Peter Rost, M.D., is a former Pfizer Marketing Vice President providing services as a medical device and drug expert witness and pharmaceutical marketing expert. Judge Sanders: "The court agrees with defendants' view that Dr. Rost is a very adept and seasoned expert witness." He is also the author of Emergency Surgery, The Whistleblower and Killer Drug. You can reach him on rostpeter (insert symbol) hotmail.com. Follow on https://twitter.com/peterrost
Wednesday, August 26, 2009
Tuesday, August 25, 2009
Monday, August 17, 2009
La Camisa Negra
Saturday, August 15, 2009
Wednesday, August 12, 2009
The story about Pfizer's CIA agent who caused the court to issue a restraining order against him and Pfizer goes on.
Here's a fine kettle of fish. Pfizer's lawyers hired a detective who ended upintimidating a witness the day before he was due to testify, according to this Law.com article, Why Did Pfizer Resort to Michael Clayton Tactics at First Neurontin Trial?:
Did Pfizer, the world's largest pharmaceutical company, cross the line on the eve of last month's crucial test trial involving its controversial anti-seizure medication Neurontin?As the judge puts it, though, it all has a bad feel, and she ordered the lawyers for Pfizer not to contact the witness ever again. The witness was courageous enough to testify anyway, as I'll show you, but the reason I bring it to your attention is this: the opening statements at trial are really outstanding, so much so I thought you'd enjoy reading them, despite the unsavory detail about the detective, whatever the truth is about that.
Two weeks after the trial abruptly ended with the plaintiffs agreeing to dismiss their case with prejudice, questions linger about why Pfizer sent a former CIA agent and private investigator to the home of a whisteblowing scientist the day before he was scheduled to testify. The scientist, David Franklin, told the Am Law Litigation Daily that he and his family felt harassed and intimidated by the Pfizer investigator's appearance at their home and are still shaken by the event. The judge overseeing the Neurontin multidistrict litigation, Boston federal district court judge Patti Saris, issued a restraining order instructing Pfizer and the investigator to stay away from Franklin and his family.
Pfizer, which was represented in the case by Skadden, Arps, Slate, Meagher & Flom and Boies, Schiller & Flexner, has apologized to the court for the incident, but maintains in a newly filed brief [PDF] that Franklin exaggerated the facts "to attract negative media attention to Pfizer." Skadden and Boies Schiller lawyers say in the filing that Pfizer's investigator followed standard protocols and was not hostile or threatening to the scientist or his family. They have asked Saris to lift the restraining order.
The transcript of the day of the opening statements [PDF], beginning on page 3 of the PDF, also includes the on-the-record sidebar discussions with the judge, so you can read how judges really talk to lawyers in real life in those sidebars we never get to hear in the SCO litigations. Happily, we can read it all, including his testimony, because AmLaw went to the expense of obtaining the transcript from that day (and the next), at which point in the trial, the case was over. The opening statements are not to be missed.
You can't know which side is in the right from opening statements, I must caution you, because opening statements are not evidence. They're what the lawyer on each side intends to attempt to prove with evidence during the trial, and lawyers, as you've observed, can sometimes really dance so fast and so expressively they virtually spin into the air in the opposite direction from terra firma.
But not here. All you will see is great skill, on both sides. The case is a sad one, about a woman who killed herself, leaving behind a little girl. The estate was suing, and at issue was whether or not the Pfizer drug, Neurontin, was a significant cause. Mark Lanier, who you can view teaching a class at Harvard on YouTube, represents the plaintiff, and he's mesmerizing. He's the attorney who won a $253 million judgment against pharmaceutical giant Merck & Co. over the painkiller Vioxx. If you watch the YouTube video (more Lanier videos on Harvard Law School's Project on Law and Mind Sciences site), you'll see he's trying to be mesmerizing. He says judges get bored, and so do juries, so it helps to try to be interesting. And he's effective, very skilled at explaining complicated things so they are understandable and clear. By the time he finished speaking, I was totally hating Pfizer and wanting to give that little girl some money.
By the way, on the YouTube segment, he mentions that in Texas, plaintiffs lose on appeal 87% of the time, that the appeals court in Texas is very, very political, and appeals judges there are voted into office and then tend to vote cases according to their party line, no matter what. I know. Disturbing, especially if you extrapolate to SCO. I wonder how it is in Utah? Remember how SCO, when it first sued IBM, sued in state court?
But notice in his opening statement how he takes a very difficult assignment on, to make the mother who committed suicide seem human, despite the fact that her life was deeply troubled and frankly not readily appealing. And note particularly how he explains the difference between cause and significantly contributing cause, with his baking bread metaphor on page 5 of the PDF:
MR. LANIER: There's a difference between something being the cause and a significant contributing cause. If you're baking bread even, you know, it rises in the oven -Simple. Understandable. Moisture might be important, but without yeast, there's no bread. So yeast is significant. Moisture less so. Here's a case where the issue was about whether a job was a significant contributing factor in developing carpal tunnel syndrome or not, to help you see why the definition matters, and why this attorney wanted to be sure the jury understood the distinction.
MR. OHLEMEYER: Your Honor -
THE COURT: Overruled.
MR. LANIER: -- it rises in the oven because of yeast, but it needs more than just the yeast. It needs the moisture and the food for the yeast. There are contributing causes beyond just one sole cause in many events in life. And so you'll hear the evidence and a chance to decide whether or not this drug was a significant contributing cause.
Then Boies Schiller's guy, William Ohlemeyer, stands up, on page 12 of the PDF, and he did a very effective job of raising doubts in my mind about whether the drug was actually the significantly contributing cause, including by pointing out that the doctors will be testifying that they had no contact with any Pfizer marketing and stressing how many times the mom had already tried to kill herself.
And then the whistleblower, David Franklin, takes the stand, on page 23, and he confirms everything that Lanier has told us about the company marketing of this drug. That still, by the way, doesn't mean that Neurontin caused this woman's suicide. She had tried several times before. But with such effective opening words, I know if I were on this jury, I'd be noticing every piece of evidence that matched what Lanier told us, because he made me care. See what you think.
The trial stopped after three days, subject to a deal of a kind I've never heard of happening, a friend of the family offering money to care for the little girl. Maybe Lanier's opening got to him or her also.
The transcript reveals that Pfizer tried to block Dr. Franklin's testimony. Here's what the judge thought, after a brief sidebar discussion where Boies Schiller's lawyer brings up a matter for the third time -- well, you know Boies Schiller guys never give up -- and then tries to get Franklin blocked from testifying:
JUDGE SARIS: What? Let's do it now, quick.And so they do. The jury isn't hearing this conversation, of course, but it's part of the record. See how plainly she speaks? And how she totally gets the Boies Schiller style, and she's just not having it.
MR. OHLEMEYER: Two big ones. Number one, we're very concerned that the ruling you made on the plea has been expanded upon in terms of talking about the amount of money in the plea. We don't think that should have been raised in the opening.
THE COURT: Overruled. I found the brief that was given to me yesterday was a rehash, except it added the due process argument over the others. I actually thought it was a fully appropriate opening statement, I wasn't sure what to expect after yesterday, but it was fully appropriate. It wasn't overblown, it was only mentioned in a line or two. I have nothing wrong with it. What's the next one?
MR. OHLEMEYER: In light of the opening statements, I think you now know from what's been said that Dr. Franklin's testimony is going to be about a time frame in 1996 -- let me just make my point, your Honor, please - that has no connection with the doctors in this case.
JUDGE SARIS: You have raised this point now three times, and I've overruled it three times. It goes to the corporate intent. Besides, a plea can be used to impeach someone testifying, and that the corporation's agents are testifying. I am not going to preclude Dr. Franklin from testifying. It goes to corporate intent, corporate motive, the scope of the understanding of where it was being sold, so the scope of the duty. I am not excluding the testimony. I understand you've now ramped it up by claiming it's a due process violation. It's not a due process violation. This isn't even 404(b). This is about this drug and the efforts to market this drug and how it may or may not relate to corporate intent.
You both did -- I'm telling my law clerks -- two of the best opening arguments I have heard in a very long time. The interns were here, honored to hear it. Let's just hear the evidence. Let's go.
So they lose that point and Dr. Franklin is allowed to testify. Just before he does, on that same page 23, the information about the private detective appears:
MR. LANIER: Judge, one last point that I do need to put on the record.Franklin then takes the stand, and he tells what happened the day before:
JUDGE SARIS: What?
MR. LANIER: David Franklin is going to testify about yesterday a private investigator calling himself a detective sent by Pfizer to his house would not leave his house until the police were called with 911 because of his persistence in trying to get Franklin to visit with the Pfizer people before he testified today, specifically blocking the driveway saying he would not leave, would not let anybody -
JUDGE SARIS: All right.
MR. LANIER: I just want to on the record.
JUDGE SARIS: Was it Pfizer's person?
MR. LANIER: His name was James Danforth.
MR. GOODELL: James Danforth was asked to find -
JUDGE SARIS: Who's Danforth?
MR. GOODELL: He's an investigator. He was never instructed to do that.
JUDGE SARIS: Well, then you're going to have to put him on the stand.
(End of discussion at sidebar.)
(Jury entered the courtroom.)
MR. LANIER: Your Honor, the plaintiffs at this time would call Dr. Dave Franklin to the stand.The New York Times in 2003 interviewed Franklin about his whistleblower lawsuit against Warner-Lambert, which was subsequently bought by Pfizer, and he gave more details about the threats:
DAVID FRANKLIN, having been duly sworn by the Clerk, was examined and testified as follows: ...
Q. Would you please tell us what you personally experienced yesterday morning as you got ready to deal with this case?
A. My wife and my daughter ... were home, relaxing. I was anxious about this experience.
Q. How old is [the daughter]?
A. Eight. She's eight years old.
A. So horsing around with [his daughter], playing with [her] when my wife noticed she had a voicemail. It was from someone who said he was a detective working on a federal case, and he was searching for someone who lived in Massachusetts that he believed she knew, and that he needed to contact this person immediately and needed to hear back from her immediately. This came -
Q. Did you have a chance to hear the message yourself?
A. Yes, I did.
Q. What did you observe next in regards to this message?
What happened next?
A. She called back. We -- the only federal case that investigators have ever contacted me about was involved with my experience working at Warner-Lambert, so we assumed it had something to do with that. The fact that the call came in on my wife's cell phone was unusual in that everybody else, when they try could contact me, contacts my attorney.
Q. Your wife -- did she used to work for Pfizer?
A. She did.
Q. What -- did you ever find out who this fellow was?
A. Yes, he called back again, called back, I was standing there with my wife and he called back and told him -- told my wife -- this time -- well, actually, let me correct that. My wife called him and -- returning the call, and he reiterated that he was a detective working on a federal case, the federal case was Bulger v. Pfizer, and my wife is an attorney, she doesn't practice any longer, but she did go to law school, and recognized that wasn't the way a federal agent would identify themselves. So she asked the person, Well, who -- you know, what agency do you work for? He said he didn't work for an agency. She said, Well, who do you work for? He said, A large group of law firms. And she goes, Who ultimately do you work for? He said, I work for Pfizer.
Q. Did this gentleman at any point in time come out to your house yesterday?
A. Yes. At that point my wife said I'm sorry, I don't have anything to say to you, and hung up on him. He called back about 30 minutes later and insisted that he speak to her and that he had an urgent message to deliver to me and needed to see me face to face, and that he wasn't going to accept no from her if she didn't put us in contact, he would -- he would not let it go, he would come to what he believed to be her home. He would -- this was -- the quote was, you will see me, this isn't going to end.
So at that point my wife is now a combination of agitated and terrified, and hangs up on him again.
Getting to your question, later on in the afternoon, my daughter was getting ready for karate ... it was time to leave. I was changing to meet you for the first time and noticed that there was an individual with his truck parked at the top of our driveway, and he was standing at the top of the driveway pacing back and forth, speaking on the telephone. Now, in the context of the two earlier conversations, we were alarmed that it was him.
Q. What did he look like?
A. Big guy. Granted, I'm a short guy, so everybody seemed big to me, but he was a large individual. He had said to my wife in that second conversation that he was a police - that he had been -- he was a retired police detective, but he was a big strapping guy. He wore black -- those black kind of aviator sunglasses that obscured much of his face.
So he was at the top of the driveway, apparently it looked like he was waiting for us, pacing back and forth.
Q. What did you do next?
A. Well, at that point my wife was -- we were all, quite frankly, terrified. I left Pfizer 13 years ago tomorrow, and when I was leaving, I -- we received threats that there was no way the company was going to just let this go, so after 13 years, having a Pfizer representative standingat our driveway scared the hell out of us. Couldn't believe that it was happening after 13 years.
Q. So what did you do? By the way, you said you left Pfizer 13 years ago -
A. I'm sorry, I left Warner-Lambert. I left Warner-Lambert, yes. Well, while we were trying to figure out what to do, I took [the daughter] upstairs immediately, we didn't want her exposed to any of this at all, and he disappeared. What he had actually done was came down our driveway so he was so close to the house we couldn't see him anymore, and so I from the second floor yelled down to my wife that the car is still there, he must be coming to the house, and my wife went to the front door and found him -- we have -- I'm sorry -- our front door and on either side of our front door we have a stack of windows on either side, and he was looking into the windows, saw my wife and was waving his 17 business card at her, smiling that -- he didn't say this, but he was clearly signalling that he was indeed following through with the threat that he would show up at the house earlier.
We called 911 at that point, called the police, said that there was this person doing this. My wife explained to them that I was -- in 24 hours I was scheduled to testify here and we were scared. The police showed up. So my wife had 911 on the phone and actually pressed the phone -- because he was barking things at her, she held the phone up to the pane of glass that he was looking through to demonstrate to the dispatcher on the other side that this was real, you know what I mean, this guy was angry.
So she yelled at the guy -- the dispatcher - yelled at the guy that she had called the police, this was the police, the police were on their way and he needed to leave. And he walked up the driveway, got in his car, drove away, and the police stopped him -- I didn't see this, but the police came to our house -
Q. We're not allowed to get into hearsay of what the police told you, so I'm going to set that aside.
Q. Did you have anymore intrusions into your life from this gentleman or is that the end of your direct involvement with him?
A. That was the end of -- he did not come back.
Q. And this is right before you and I met for the first time yesterday afternoon to discuss what you had to say to the jury today?
A. Yeah, literally -- I noticed that he was there was I was pulling my pants up in my bedroom. So, yeah -- we would have -
Q. You weren't doing that in front of that window pane, were you?
A. No, but he -- he was blocking the driveway, so in just a matter of moments my daughter going to karate -- my daughter would have encountered first, she was on her way to karate, they would have encountered first.
Q. At some point in time did you hear your wife say to him something to the effect of how do you even know who I am or something like that?
A. He was saying that he -- he described to her when he - when he called the second time, that there was -- that he knew everything there was to know about her, but seemed to be confused about whether or not we were actually married. And so he was asking questions about whether or not she was married to me. But he then rattled off my wife's -- lots of details about my wife, about her business, that she was - had gone to law school, that -- so he -- he demonstrated that he did know a great deal about my wife, but he was confused about whether or not we were married.
Q. In light of all of this, as I asked you yesterday afternoon, I'll ask you today in front of the jury in court, are you still willing to testify and tell the jury what happened about your time at Warner-Lambert?
A. Yes -- I've been subpoenaed, but, yes, I am. My daughter's afraid of the guy at the door, so we didn't get much sleep last night, but absolutely, no, I need to do this, yes.
He said he felt threatened when at least one executive told him that if he talked publicly about the company's marketing he would be made a scapegoat and be described as a rogue employee in a company that played by the rules.I can't help but notice that the threat was to smear him unjustly. So, getting back to the transcript of this case, the next day, as you might expect, the detective visit comes up again:
That is when he went to talk to Thomas M. Greene, a lawyer in Boston, and soon filed the lawsuit.
THE COURT: But let me just, there's one other issue. Is Dr. Franklin here?As you see, Pfizer could ask the court to remove the protection order, and they did. They did nothing wrong, they say. This detective is a fine professional, who denies it happened as Dr. Franklin claims, etc. Detectives are used all the time. Here is their side of the story:
MR. FINKELSTEIN: Yes.
MR. CHEFFO: Yes. He's in the back with Ken Fromson.
THE COURT: Let me just tell you what he reported to Mr. Alba. Whatever that guy, whoever he was and whatever he said, I think Dr. Franklin is terrified, and, more importantly, I think his daughter is terrified, and we have a thousand more cases. I can't imagine Dr. Franklin is going to travel around the country testifying in all of them, but maybe he will in a few of the lead cases. I just don't know.
I think we need to have a stay-away order from him from any private eye. I don't know who the man was, but apparently he said -- what were the words? I can bring him up here and have him say it himself.
THE CLERK: You may want to because he was very upset.
THE COURT: Yes. Dr. Franklin, come on up here.
(Dr. Franklin at side bar.)
THE COURT: Hey, how are you? Actually, you look taller when you're sitting up there.
THE COURT: Anyway, let me just say this to you, sir: I'm really taken by what you told Mr. Alba this morning, so why don't you repeat it for the --
DR. FRANKLIN: I recognize that there are two sides to every story and that I need to be fair and balanced.
THE COURT: Don't worry about that. Just --
DR. FRANKLIN: But sending a thug to my home to wave at the window at my eight-year-old daughter was unreasonable, guys. It was unreasonable.
THE COURT: Well, let me ask you, what were the words? Mr. Alba said they said something about, "We know where your daughter lives"?
DR. FRANKLIN: On the telephone, he said, "We know all there is to know about you," and then cited the location of my daughter 200 miles away at college. How the hell am I supposed to remain unbiased when you do that? It feels like a threat. It feels like a threat. Look, I know that you guys didn't tell this person to do it, but you've got to -- I believe, your Honor, that it was horribly inappropriate, and there was very few other ways of interpreting it other than really scary.
THE COURT: Dr. Franklin, this is what I'm going to do. This case, I don't know if you've heard about the resolution of it. It's likely to be dismissed.
DR. FRANKLIN: Yes. Yes, I understand. I understand, and I don't want to in any way complicate it.
THE COURT: But there are hundreds, maybe a thousand more cases, and you may be called upon to testify again. What would you like me to do at this point? Would you like a --
DR. FRANKLIN: I don't know that there's anything you can do. I would like --
MR. CHEFFO: I can make a representation. I can apologize to the extent -- see, I don't know the facts, your Honor, but profusely, I mean, to the extent that that happened, and I take you at your word. We --
DR. FRANKLIN: This can't happen 1,200 more times.
MR. CHEFFO: It's not going to happen. I'll give you my word that that's not going to happen.
DR. FRANKLIN: And I'll give you the benefit of the doubt about what happened, and I recognize --
MR. FINKELSTEIN: May I suggest, because I think it's not just Dr. Franklin, it's the rest of his family, and I think it will give him comfort to be able to walk away with this --
THE COURT: I think this is what I'm going to do right now. Until -- I understand there are two sides to every story, and Pfizer probably needs --
DR. FRANKLIN: And you had the right to question --
THE COURT: Has the right to question, I understand that. But until further order of the Court, there should be a stay-away order from any private eye with respect to Dr. Franklin or his family. And you should -- I don't know that you want to give me the names and addresses of your family. Let me just make it that specific. He's been deposed a gazillion times. Isn't that "gazillion" your term?
MR. LANIER: Yes, your Honor. It's an appropriate word.
THE COURT: And people know what he has to say, and there will be a stay-away order from anybody from Pfizer having to do with Dr. Franklin.
And you may want to do your own investigation and put your own version on the record for future -- you know, like, it may come up in Texas or Tennessee, you know, whatever. I mean, this is not the -- but I'm not necessarily saying that there isn't another side to the story. I am saying I see a terrified witness. Something happened. So whether or not he's overreacting or not, I don't know, but he's terrified, and there was a reference to his child.
And so why don't we do this: There will be a stay-away order until further order of the Court, and we will inform you of any -- I'm sure you'll want to talk to -- has anyone here talk to the private eye?
MR. CHEFFO: Well, we had a conversation last night, and, I mean, there are two sides to the story, but I think we're kind of past that right now. And, as I said, I can't say it any more, I do apologize if there was anything inappropriate. That was never an intent. Certainly we didn't advise that. There will be no more private eyes. The only thing I would ask is, to the extent that he is going to be a witness, we would like a mechanism, if he has a lawyer, a place that we can serve so there is no disputes.
THE COURT: Yes, I think Mr. Greene has historically been his lawyer, right? Tom Greene has been here since 1995. I mean, I had this case before any of you existed, so -- I think it's been that long. Isn't it Greene still? I saw him sitting back there.
DR. FRANKLIN: Yes. And in this case, I don't understand why Mr. Greene wasn't asked to talk. I had already told him, I told everybody that I will talk to anybody --
THE COURT: Yes, from now on, all communications should be through Mr. Greene.
DR. FRANKLIN: I don't understand why a private detective showed up at my home.
THE COURT: All right, so there's a stay-away order from you or any member of your family. All communications should flow through counsel. And if Pfizer, because I haven't heard the other side of the story, and if Pfizer should for the record want to put anything in and oppose this and move to vacate it, they can do that. Okay? But right now, I want to respect what you've said to me under oath yesterday and your continuing concern. And I am going to dismiss this case, but there will be another one in January-ish, February.
PRELIMINARY STATEMENTThere you are. This part of the filing is followed by legal arguments, and you can read them all for yourself. The reference to the mystery about donating money is explained in this article, which at least includes a more noble response from Ohlemeyer:
In issuing the restraining, or “stay-away,” order on July 29, 2009, this Court recognized that it had heard only one side of the story – Mr. Franklin’s – and that Pfizer could submit papers to clarify the record and move to vacate the order. (See Exh. A, 7/29/09 Hr’g Tr. at 15-17.) An accurate statement of the facts, as set forth in the accompanying Declaration of James Danforth, confirms that a restraining order involving Mr. Franklin is unwarranted and unnecessary.
As this Court is aware, both Plaintiffs and Defendants have routinely used investigators in this litigation. Pfizer certainly did not, as Mr. Franklin told this Court, “send a thug to [his] home to wave at the window at [his] eight-year-old daughter.” (7/29/09 Hr’g Tr. at 13:16-17.) Mr. Danforth is a 54-year-old former police officer and an experienced and highly regarded licensed professional detective and investigator. On the afternoon of Monday, July 27, he made a brief and unobtrusive attempt to contact Mr. Franklin simply to determine whether he was available to speak with counsel for Defendants. Mr. Danforth did not know, and had no basis to know, that Mr. Franklin was represented by counsel in connection with this personal injury litigation, which comes years after the separate Neurontin qui tam litigation in which he was a party. Mr. Danforth properly identified himself to Mr. Franklin’s wife as a detective who was working with counsel for Pfizer in the case of Bulger v. Pfizer, and promptly left Mr. Franklin’s property after his wife indicated that neither she nor Mr. Franklin would speak with him and that he should leave. (Exh. B, Danforth Decl., at ¶¶ 12, 17.)
As Mr. Danforth’s Declaration establishes, the facts surrounding his brief contact with Mr. Franklin and his wife are not as Mr. Franklin represented them before this Court. Nor was Mr. Franklin’s claimed reaction of fear reasonable based on the facts. Rather, it appears that Mr. Franklin’s exaggerated account was calculated to inflame the jury against, and attract negative media attention to, Pfizer. Indeed, as soon as they had dismissed the Bulger case on July 29, Plaintiff’s lawyers began giving interviews to the press about Mr. Franklin’s testimony about Mr. Danforth, undoubtedly to distract the media from the fact that Plaintiff had just dismissed the case with prejudice after only one day, and to divert questions about who paid the minor Plaintiff and why Ronald Bulger, Jr.’s claims were dismissed by Plaintiff David Egilman without any payment to him.
The corrected record confirms that a restraining order against Pfizer and Mr. Danforth, based solely on Mr. Franklin’s inaccurate representation of the facts and unfounded claims of fear for his family, is not warranted and is likely only to unfairly impact the reputation and livelihood of Mr. Danforth. Moreover, the order is unnecessary. Although Pfizer believes Mr. Danforth had the right to determine whether Mr. Franklin was available and to ask to speak with him based on his reasonable understanding that he was not represented by counsel in this litigation, Pfizer will, consistent with this Court’s guidance, contact Mr. Franklin only through the counsel he subsequently designated (Thomas Greene), and Mr. Danforth will not attempt to contact Mr. Franklin or his family.
On July 20, 2009, counsel for Plaintiff in Bulger indicated that Mr. Franklin, a non-party, may be called as a live witness at trial the following week. (See 7/20/09 Hr’g Tr. at 11:16-18.) In an effort to identify Mr. Franklin’s contact information and determine, before the start of trial, whether he was available to testify, Pfizer retained the services of Mr. Danforth, a licensed private detective.
Mr. Danforth is a graduate of Merrimack College in Andover and a former U.S. Marine. He served as a federal agent and a detective and officer in the Fort Lauderdale Police Department before becoming a licensed detective and private investigator in Massachusetts 1994. (Danforth Decl. ¶¶ 3-5.) He has served as a consultant and provided expert testimony in civil and criminal cases. (Id. ¶ 5.) Mr. Danforth has never been the subject of any sanction, reprimand, censure, investigation, or charge in connection with his work as a private investigator, and has never before been the subject of a restraining order. (Id. ¶ 6.) He has never, to his knowledge, been described as having a threatening, intimidating, or menacing appearance or demeanor. (Id. ¶ 7.)
Mr. Danforth went to Mr. Franklin’s home in the afternoon on July 27 after he was unable to confirm, through searches of publicly available records, a business or home telephone number for him. (Id. ¶¶ 9-17.) Mr. Danforth had also been unable to confirm Mr. Franklin’s address or contact him by telephoning Ann Laquerre, a Massachusetts attorney whom Mr. Danforth believed was possibly, and who indeed is, Mr. Franklin’s wife. (Id. ¶¶ 11-13.) Mr. Danforth had told Ms. Laquerre over the phone that he was a private detective working for several law firms representing Pfizer in connection with a federal case and that he was trying to locate a possible witness named David Franklin. (Id.) During two telephone conversations with Mr. Danforth, Ms. Laquerre never confirmed that Mr. Franklin was her husband, never advised Mr. Danforth that Mr. Franklin was represented by counsel, and never told Mr. Danforth that she had given Mr. Franklin the message and that Mr. Franklin did not want to speak to him. (Id.)
When he attempted to contact Mr. Franklin at his home, Mr. Danforth was wearing typical workday professional clothing. (Id. ¶ 15.) When he arrived at the house, Mr. Danforth parked on the street, in a large space between the driveway to Mr. Franklin’s house and the house next to it, and made sure that his car was not blocking either driveway. (Id. ¶ 13.) After confirming with a neighbor who was standing outside that he had found the correct address for Mr. Franklin, Mr. Danforth walked to the front door of the Franklin residence, rang the doorbell, presented his business card through the window to Ms. Laquerre, and indicated, through the door, that he was there to speak with Mr. Franklin, if he was available. (Id. ¶ 15.) Ms. Laquerre responded that she had called the police. Mr. Danforth then left his business card in the door, returned to his car, stood outside his car briefly to call David Chaffin, counsel for Defendants, and then drove away. (Id. ¶¶ 17-18.) When Mr. Danforth encountered a police car driving towards Mr. Franklin’s street, he waved the car down, provided identification and his business card to the officer, and explained that he was a detective and private investigator and had been trying to speak with Mr. Franklin at his house. (Id. ¶ 18.) The officer called Mr. Danforth a short time later, after speaking with Mr. Franklin or his wife, and Mr. Danforth advised the officer that he would have no further contact with Mr. Franklin, and should it become necessary to contact Mr. Franklin in the future, he would contact the officer or one of his colleagues to accompany him. (Id.) Mr. Danforth did not make any further attempt to contact Mr. Franklin and will not attempt to contact him or anyone in his family in the future. (Id. ¶¶ 18, 20.)
Mr. Danforth has attested:I take my work and reputation as a meticulous, reliable, and law-abiding licensed private detective and investigator very seriously and am very concerned about the entry of a restraining order by this Court in connection with my attempt to contact David Franklin. I was stunned to read what Mr. Franklin said about my conduct and interaction with Ann Laquerre. I do not feel that I did anything improper or unusual in my attempt to contact Mr. Franklin. I acted professionally at all times and followed the normal standards and procedures that I use in attempting to contact any witness. I never acted hostilely or with malice. I never threatened or harassed Ms. Laquerre, Mr. Franklin, or anyone in their family. I never told Ms. Laquerre that I knew everything there was to know about her or her family or that I knew the location of their daughter in college. What I told Ms. Laquerre is that I knew that she and Mr. Franklin had resided in the same household and that they shared business interests, in the hope of gaining her cooperation.
He said the detective was hired to ask Franklin if he planned to testify and what he would say, a common practice during trials.I think if they'd left it like that, made their record without trying to smear Dr. Franklin, it would have looked better. It's an appropriate thing to do, to apologize to someone who says you have disturbed and frightened him, even if you didn't mean to or think they are overreacting, don't you think? In other words, I don't think they had to demean Franklin to get the order removed. You make your choices. And here is who wrote the motion, or more accurately who signed it: Mark Cheffo of Skadden Arps, William Ohlemeyer of Boies Schiller, and Scott Sayler of Shook, Hardy, along with the local MA firm for Pfizer, David Chaffin of White & Williams. He served it, so he may have written it.
"It sounds like this didn't happen the way it should have happened," Ohlemeyer said. "We apologized to (Franklin) for what happened."
Logic interferes with me fully believing the Pfizer document about the detective. Did you notice the first story is that they just wanted an address so as to serve him? Then, in the document, it was that they wanted to talk to him. But it also says the detective was trying to determine his address. But the account about the detective says, "After confirming with a neighbor who was standing outside that he had found the correct address for Mr. Franklin, Mr. Danforth walked to the front door of the Franklin residence..." If he just wanted to confirm an address, there was no need to walk to the front door. So I think we can rule out that story.
If they wanted to talk to him, the day before his testimony, then it makes more sense. But who wanted to talk to him? The lawyers or the detective? By confirming the address with the neighbor, having already spoken to someone there by phone, his wife, he also by then knew the phone number to reach Dr. Franklin, no? So the lawyers had what they needed to call him any time. The document says it was the lawyers who wanted to talk to him. So what was the detective there for? Did the attorneys intend for the detective to speak with Franklin first? The article says the detective was to ask him about his testimony of the next day. The lawyers wouldn't do that themselves?
And speaking of logic, try putting these two sentences together in your brain simultaneously, if you can:
See what bothers me about this story?
- Mr. Danforth properly identified himself to Mr. Franklin’s wife as a detective who was working with counsel for Pfizer in the case of Bulger v. Pfizer, and promptly left Mr. Franklin’s property after his wife indicated that neither she nor Mr. Franklin would speak with him and that he should leave.
- During two telephone conversations with Mr. Danforth, Ms. Laquerre never confirmed that Mr. Franklin was her husband, never advised Mr. Danforth that Mr. Franklin was represented by counsel, and never told Mr. Danforth that she had given Mr. Franklin the message and that Mr. Franklin did not want to speak to him.
By the way, I found a publicly available business phone number for Dr. Franklin, but I'll never tell you where, so he doesn't get harassed. But if I can do it, why couldn't anyone? Maybe I should go to work for the CIA or be a private detective.
Here's why I tend to believe Dr. Franklin, anyway. When he's telling about how he came to get the job at Warner-Lambert, now Pfizer, he tells how in his job interview, they asked him several times questions about how he has handled bending the rules in gray areas in his life. He's such a straight arrow, he can't think of ever having done so:
And so I was prepared for that type of very technical scientific conversation, even though I knew that I was applying for -- I had initially applied for a -- excuse me, a sales job. At this point I knew that I was actually applying for the medical and scientific liaison position. So I expected a science sort of discussion. ... So when I got down there, the conversations were much more, in retrospect, sales oriented. The primary theme of the -- the theme that stood out was -- everybody that I interviewed with was -- either asked me or prepared me to answer questions about times when I've had to bend the rules. Give me examples of when you found yourself in conflict or you found yourself in a place where you were working in a gray area, how did you handle that? And boy, that wasn't in the how to interview book, and I really -- I had a difficult time. I struggled with coming up with an example of a case of where I had been in a gray area or I had to bend the rules.Is that not touching? He comes across as a really honest guy, who doesn't even understand the question about bending the rules, so foreign a concept it is to this man. An honest, decent person, from all appearances, caught in the maws of a large corporation's law firms, willing to hire detectives to show up at people's houses the day before they are due to testify. To me, you see, it doesn't matter how the detective behaved that day. Let's credit his account. Showing up at *all* that day -- that is the questionable conduct to me. And I doubt there is a human being in the world, on a jury or not, who wouldn't agree and who wouldn't think to him or herself that when a witness has a detective show up like this at the home, the witness is likely telling the absolute truth.
Q. And did this come up once? You called it a theme. How often were you talking -- asked about or discussed with in this interview process bending rules or gray areas?
A. Three separate times.
Q. What did you tell them?...
A. So what Mike was -- he asked me directly to give him an example of where I needed to bend the rules or work in the gray area, and I struggled with it. I did one of those awkward sort of sweating trying to come up with the -- an example. And the example I had come up with, I had as a graduate student I had designed an exam and made the rules -- I structured the question and instructed the grading of the exam so that the student -- one of the students -- this was a microbiology class, actually figured out -- found a loophole in the way I had structured the exam so that if you didn't answer any questions, he actually got -- he would get an A. And so he handed in a blank exam and then pointed out to me that the way I had structured the exam there was no way I could fail him, and he was correct. He was right on that.
Q. Did you become most popular professor on campus at that point?
A. I corrected that error quickly, and he was the only one who figured it out. So I attempted -- I explained that, where I had created the problem and had somebody that was taking advantage of a mistake that I had made that was clearly not within the spirit of exam taking, but it clearly did not -- that kind -- that conversation of how I dealt with the student, talked to the student about him not appreciating the point of taking an exam, he might clearly -- that was not my -- what my response did not answer his question.
I know. There's two sides to every story. But sometimes only one of them is so. By the way, guess what Pfizer wanted Dr. Franklin to do? His testimony is that they wanted him to visit doctors and convince them that Neurontin was fabulous for things the FDA hadn't approved the drug for. I didn't know that CVS and Walmart sell their lists of what doctors prescribe to companies that then sell them to companies like Pfizer. That's got to ring the chimes of yuckiness pretty loudly. But apparently that is what happens. So he was supposed to go down the list, calling on these doctors, focusing on the ones who prescribed the most in the areas of interest.
Lanier explained how that off-label selling works in his opening:
They have a market of $50 million, so they start trying to figure out what they can do to expand the market. The drug company makes a conscious decision to do something that is illegal. The law says the drug company can only market the drug for its approved purposes. That law doesn't apply to doctors. Doctors can write prescriptions all the time for whatever the doctor thinks is appropriate, but the drug company can't go out there and market and sell the drug for what's called "off-label." Important words, if you don't mind me just writing them down for a minute. "Off-label." Off-label marketing is "illegal."It goes on, and I'll never fill a prescription again as long as I live without thinking of this and wondering if I really need it or if it's really safe.
Now, that may seem oversimplistic, and I'm not trying to turn this into law school, but it's illegal. You can't do it. The drug companies can't do it, and they know it. The thing is, the drug company figures out there's a world of people paying big dollars for drugs for things that Neurontin has not been approved for, but Neurontin falls into this class of drugs called antiepileptic drugs, AED. Anti, against, epileptic, epilepsy, drugs. And some doctors have used antiepileptic drugs before to help people with pain. Well, that would be huge. The pain market is big.
So what the drug company starts doing is making a deliberate effort to illegally market this drug off-label. I don't know what it is in your life, there's got to be something in your life that relates this way to you. The picture I always get in my brain is from cartoons growing up. When I grew up, you remember we had the Bugs Bunny - some of you may be too young to remember that -- but the Bugs Bunny cartoons and all of that? Have you ever seen the cartoon where they have the snowball that starts at the top of the hill and it starts rolling down, and as it gathers momentum, it just gets bigger and bigger; and then, you know, you've got arms and legs of people in the way flying out and all, and it's gets on down the hill.
What the drug company does is makes a conscientious decision to market this off-label in a way where it takes on a life of its own, and it becomes a massive growing snowball that nothing really is going to get in the way and stop. They enter into an elaborate programmed plan to deliberately get doctors and people thinking that this drug is the wonder drug that will cure anything that ails you....
Our first witness is a fellow named David Franklin, and we'll start him with the Court's permission before today is over, but it will take through tomorrow to finish him up with all the questions that we've got and that they've got. David Franklin is an interesting fellow. He graduated with an undergraduate degree in microbiology from the University of Rhode Island. Then he gets his Ph.D. from there, and he's working at Dana Farber as a cancer researcher and doing cancer work over at Dana Farber.
He gets a job going to work for the drug company. When he gets the job, he's being told -- now, he's not a medical doctor. You'll hear all about this. He's just a Ph.D. He doesn't wear a stethoscope, he can't write prescriptions, but gets hired at triple his former salary so that on behalf of the drug company he can go into the doctors' offices where he's introduced as a doctor, never being told, well, not really a medical doctor. And he sits there and he's trained to teach these doctors and convince these doctors to write prescriptions for Neurontin for off-label reasons, to write prescriptions for Neurontin to cure ADD in children, to write prescriptions for Neurontin to do all sorts of different things. I'll ask him; you'll get to hear him.
He'll tell you that that wasn't the only thing; that the drug company also told him to go out there and to convince the doctors to write what's called megadosing. You see, it's not enough that the drug company is going to try and expand their profit margins by selling it off-label. The FDA only approves it in dosages up to, I think at the time it was 1,800 milligrams, but the salespeople are told to go out there and to convince the doctors that they can do not 1,800. "Give them 21, give them 25, give them 28, give them 31, give them 4,000, give them 4,800 a day, more and more and more pills. Get it up as high as you can." There's a joking memo about one woman who's on the drug who winds up trying to commit suicide, and she's taken hundreds of them to try and do it, and the joke within the drug company was, "That was the world's most expensive suicide attempt." But they're pushing this drug in ways outside the label and at dosages not approved. Now, there are some restrictions on how they can do this and what they can do with the doctors. You, for example, if you're a drug company are not allowed to pay a doctor to write a prescription, and aren't we glad? Wouldn't you hate -- golden rule, excuse me, your Honor. It's a good thing that drug companies don't have the power to pay doctors behind our back to write prescriptions for us. That's an important public health policy. But the drug company found what they thought was a way around that. They would go to the doctors, and they would say, "Doctor, I can't pay you to write a prescription, but I'll tell you what I can do. If you'll let me watch you write the prescription, we'll say that I'm learning from you. I'm learning how you sign your name. I'm learning how you write a prescription. And I can pay you 350 bucks if you'll let me do that.
So it's illegal, but this honest man was being trained to do it, and his conscience troubled him. On the stand he is asked by Lanier if he felt a letdown when he realized what the job really was:
A. No -- I think the question -- that doesn't capture - how do I put it? It wasn't a letdown. I knew I was applying -- I had applied for a sales job. Eventually I realized that I was in a sales position. If I had taken the sales job and found myself, you know, four months later in a sales position, I would have gotten what I expected, where the disappointment or the letdown was that the sales position -- the sales that I was responsible for were sales that were prohibited by the -- by law. And so my letdown, if you will, was that I was selling products illegally. So it -- how do I put it -- that -- I guess I've answered it with a long answer, is the letdown, because I applied for a sales job, I found myself in a sales job would be -- letdown wouldn't actually capture that. That would be what I actually expected. What the letdown actually was, was that I was in a sales job where my responsibility was to sell products illegally.So, he left, and if you read this affidavit [PDF] from his earlier qui tam, which means whistleblower, lawsuit regarding Neurontin, which resulted in a $430 million fine against Pfizer, you learn he only worked there for four months before quitting. You can read about the earlier case, and find out what all that money in damages went to fund here:
In December of 1993, Parke-Davis, then a subdivision of Warner-Lambert, received approval for its drug Neurontin® (gabapentin) by the Food and Drug Administration (FDA). The original FDA approval stipulated that Neurontin® could be used in conjunction with another drug to control epileptic seizures. Since 2002 Neurontin® has been approved by the FDA to control residual pain after shingles. In 1996 the manufacturer hired Dr. David Franklin, a microbiologist and former fellow at Harvard Medical School, as a medical liaison, an expert field scientist to answer prescriber questions. Soon after Dr. Franklin started the job he had tremendous qualms about what he was doing. Franklin says “he became part of a broad mission to deceive, even entice doctors to prescribe drugs to patients whether it was scientifically justified or not.” One of things Dr. Franklin was hired to do was to push the off-label uses of the drug Neurontin®. Prescribers may prescribe an off-label use for a medication if it is good medical practice to do so. However, manufacturers are prohibited from marketing medications for off-label uses.There's a browsable Drug Industry Document Archive at the U. of California, San Francisco, made possible by that trial:
Dr. Franklin filed a federal qui tam, or whistleblower lawsuit against Pfizer, which had acquired Warner-Lambert and its Parke-Davis division in 2000, charging the company with violations of the False Claims Act. Profits for sales of Neurontin® were increasing from $97.5 million in 1995 to $2.5 billion in 2003. Further, Warner-Lambert reported in 2000 that up to 78% of the prescriptions for Neurontin® were for off-label purposes. The U.S. Attorney’s office in Boston intervened, brought more charges under FDA criminal statutes. This private/public charge on pharmaceutical industry giant Pfizer forced a settlement in the amount of $430 million, the second largest settlement of its kind. While Direct-to-Consumer advertising is rampant, what is more hidden is the industry tactics to influence the prescribing practices of doctors. In this case, we are given a glimpse into the $20 billion spent annually on marketing and promotion by the pharmaceutical industry.
The Drug Industry Document Archive (DIDA) contains over 1500 documents about pharmaceutical industry clinical trials, publication of study results, pricing, marketing, relations with physicians and involvement in continuing medical education.If you search for Franklin, David, you'll find buckets of documents from the trial, including the complaint. If you click on the link to transcripts, you'll find all the filings in the case, and some depositions. It's a gold mine. The author of this Annals of Medicine article actually read 8000 pages of those documents, and analyzes them, confirming Franklin's account. Here's a resources page on the case, which includes a link to the Department of Justice press release from 2004 about the settlement, which included agreeing to a guilty plea by the company.
Most of these previously secret documents were made public as a result of lawsuits against the following pharmaceutical companies: Merck & Co., Parke-Davis, Warner-Lambert, and Pfizer. For further information on documents connected to these lawsuits, please consult The Documents.
And the Journal of Medicine published an article in January, The Neurontin Legacy — Marketing through Misinformation and Manipulation about the case, which you can purchase or read if you have a prescription, or read it here. The authors mention the legacy of this case includes this:
What is Neurontin's legacy? First, we have learned that pharmaceutical marketing can be comprehensive, strategic, well financed, disguised as "education" and "research," influential, and very effective. Promotion of Neurontin was neither discrete, compartmentalized, nor readily apparent; instead, it was intercalated in nearly every aspect of physicians' professional lives, from the accoutrements of practice to lectures, professional meetings, and publications. Although somepharmaceutical marketing may be less opaque, deceptive, and manipulative,evidence indicates that drug promotion can corrupt the science, teaching, and practice of medicine.However, Dr. Franklin stood up and refused to do it. And when he did, he changed the world for the better. That is the man that these lawyers have just described as some kind of dishonest media hound.
Second, such comprehensive marketing involved many people and institutions that apparently failed to recognize the serious ethical and legal problems with their actions. Employees of Parke–Davis, the medical-education companies it hired, and many physicians (consultants, advisors, educators, and researchers) all participated knowingly. Universities, hospitals, professional organizations, and foundations also participated, and oversight agencies such as the FDA and the Department of Justice did not intervene quickly. Apparently, there was a shared acceptance that Parke–Davis's marketing was simply business as usual.
There is an intriguing detail in this document from the earlier case, Disclosure of Information by Relator David P. Franklin Pursuant to 31 U.S.C. § 3730 b(2), in the DIDA collection:
Under initial training for medical liaisons, they were told,after the video tape had been turned off, that if they were cold-calling with a sales representatives, have the representative fillout the IRF so that they would be covered . However, when asked ifsales representatives could sign the IRFs instead of the physician,Jim Parker stated that the FDA would see that as a forgery . In aconversation on July 1, 1996 with Dr . Franklin and John Krukor,Phil Magistro said "I checked with people way over Jim Parker'shead and it's okay to have the sales reps sign the IRF forms.Really, don't worry about it, nobody checks those things anyway."Dr . Franklin replied, "I can't even get the forms themselves."Both Magistro and Krukar laughed and Magistro said, "See what Imean, these things are low priority, if something happens thenwe'll produce (laugh) what they want, don't worry." Krukar added,"In fact', I wish you guys would stop asking about this stuff, itjust makes everybody anxious. If you guys are that anal you shouldrethink if you should be part of this team . We're going places,you don't go anywhere filling out forms. If you want to fill outforms for a living, get a state job."This is the company whose lawyers now accuse Dr. Franklin of making up stories to get media attention. Who ya gonna believe?
In the entire time Dr. Franklin worked for Parke-Davis, henever possessed a Physician Information Request Form.
I'm mentioning all these resources, because it's important to make clear that Franklin's allegations against Pfizer are not untested. He, and the DOJ, won the case. There is a record here as to Dr. Franklin's believability, even if the company has had its Road to Damascus moment and has turned itself around since. And I know how it feels to be smeared. And I know it matters to put the truth out there to counter smears, so I wanted to put that information here, right beside the smear, all in one place, so that when people, including this ethical man's daughters, read about this case after finding it on Google, they'll have the entire picture.
Update: Here's Mr. Lanier's opening statement as text:
OPENING STATEMENT BY MR. LANIER:
MR. LANIER: May it please the Court, goodmorning, ladies and gentlemen. My name is Mark Lanier.It's my honor today and throughout this trial to somedegree, at least, to be able to represent Regina Bulger.Regina, would you stand up so they know who youare, please. She's that sweet little ten-year-old rightthere, who's just finished fourth grade and is startingfifth grade in the fall. She's in the summer. She's liveswith her grandmother, Grandma Pat. Would you stand up,please, and let them know who you are. And they won't behere for very much of the trial. In fact, I'm going to askthem to leave, if you don't mind, at this point now that thejury has seen you, and thank you all for coming down herethis morning.
You'll get to know more about them and you'll getto know more about why they leave as -- this gentleman who'sstanding up now is Dr. David Egilman. He teaches at Brownand is a doctor nearby, and is the legal representative for purposes of this lawsuit of the young lady that you've justseen, Regina. Thank you, Dr. Egilman.
This is a simple case, but it's a very seriouscase. It's a very serious case because it involves somedelicate issues, but it involves some important policyissues as well. And those at this point, eight of you --no, nine of you, one, two, three, four, five, six, seven,eight, nine of you that are left on this jury at this pointare actually doing something that's extremely important asyou make your way through this case. And what I get to doover the next 57 minutes at this point before I get the hookis, I get to tell you what I anticipate the evidence isgoing to be.
It's a case that evolves ultimately around thatyoung girl from here on out, but she's not the maincharacter in the past part of the story. The past part ofthis story involves her mother, Susan Bulger. Susancommitted suicide, and it will be five years ago next weekon August 4. Regina and her father, Ron, Sr., are who foundthe mom dangling at the end of a wire in the basement.
It's a tough, tough thing when you're dealing withsuicide. Suicide is not a simple matter. And we're goingto have to probe in this case, what is it that allows aperson to kill themselves? It's not something that's commonin the United States. Oh, it happens, and I think most of us, the older we get, we can find where we've brushed upwith awareness of it somewhere in our life, but what is itthat happens?
You know, the way we're made, the doctors willexplain, we've got within us kind of a wall ofself-preservation. There's this will that says, "I don'twant to stick my hand in fire. You know, it's going toburn, it's going to hurt. I don't want to do damage anddestruction to my body."
Now, some people have, some doctors call it thewill to live. Some people have a really strong will tolive. You probably heard stories about people the doctorsthought were going to die in the hospital, but they justseemed to hang on. And doctors might say they have a strongwill to live or they need to let go or something like that,but there is this wall of self-preservation that we have.And I think the evidence is going to indicate some peoplehave a bigger wall than others, some people have a reallystrong will to live. Some folks, their will to live is notas strong. Some people have a very low wall, and thosepeople are people who are susceptible to, in danger ofsomething that might hurt themselves, some type of asuicide.
The evidence in this case is going to show youthat Susan Bulger, Regina's mom, had a very low wall. She had a very, very tough life. She had a tough childhood.She grew up in an abusive home. Her parents abused herverbally. They may have abused her physically. I don'tknow. But early in her life she got hooked up with a fellownamed Ron Bulger. He wasn't the kind of guy that mostparents want their daughters to hook up with, a toughhusband. And so she's in a marriage where her husband is adrug user. He used illegal drugs, cocaine, heroin, a numberof different illegal drugs.
Susan Bulger herself lived a very tough life, didmany of the same things as her husband. She found herselfaddicted at one point in life to cocaine. She found herselfaddicted at one point in life to heroin. She tried to,maybe -- I mean, this is some degree of speculation, but sheclearly tried to at least hurt herself and gain attention,if not actually try to commit suicide, multiple times in herlife from a very early age, four, five, six times maybe,depending on how you take certain events.
She and her husband Ron, they had a son, Ron, Jr.,and you'll hear about Ron, Jr. Ron, Jr. is now in his earlytwenties. I don't have him down here. You'll understandwhy more and more as we go through the trial. You'llunderstand my concern, and what you're going to hear myevidence point to is what we need to do for this young ladyand not really for the husband --
MR. OHLEMEYER: Objection, your Honor.
THE COURT: Overruled.
MR. LANIER: Not for the husband, and not even forRon, Jr., the older brother. So the evidence is going to betargeted around the young lady, around Regina, and what Ibelieve have been her damages and what we need to do to takecare of her and keep her on a road to a good life that she'son right now.
As we look at this, though, you're going to seethat the mom, Susan, and the dad, Ron, Sr., they had a son,this older brother. Susan tried hard to be a good mom. I'msure Ron, Sr. tried hard to be a good dad. There werelimits to how good they were. They were young for thatchild, and they had struggles. They lost custody of thechild for a while because of the drug abuse in their home.It's a sad situation to sit and learn from.
Ifyou take that social sadness, add to it -- let me addanother layer now. There's not just social sadness in herlife. There are lots of other physical problems she had.Susan Bulger, the mom, had rheumatoid arthritis, painfuladvanced rheumatoid arthritis. She had fifteen, sixteen,seventeen surgeries in her life. She lost all but four ofher teeth. She had just had an elbow surgery within a fewyears of her suicide. She had aches and pains that requiredher to be on more medicines, I'd almost say more than Pfizer makes, but that's not true. I mean, just lots of medicines.I could give you big charts with 80 gazillion types ofmedicines she'd been on all of her life.
At the time she committed suicide, she's on maybefive or six medicines, but over her life she'd been on a tonof them to try and deal with the pain. She was on methadoneat the time of her suicide simply for pain relief. I thinkshe was out of tablets at the time, so she was clearlyhurting actually.
But this is a woman who had physical pain. Shehad emotional difficulties from childhood. This is a womanwho had a tough marriage. She'd been talking to some peopleabout leaving her husband. But she had a bright spot in herlife, and the bright spot was that little girl she namedRegina. It's Latin for "queen."
I think the evidence is going to show you that insome way, with the pregnancy of Regina, Susan Bulger triedto turn her life around. She went onto methadone and someother drugs while she was pregnant so she wouldn't be usingheroin. She did what she could do to try and make sure shedidn't lose this child the way she'd lost her son. Youdon't -- you know, there's the old expression, "You don'tturn a battle ship on a dime." Well, you don't turn yourlife around generally -- I know historically there have beena few roads to Damascus, but you don't generally turn a life around on a dime. But you'll clearly see that there wereefforts made. There weren't suicide attempts anymore.There weren't issues of abject drug usage, illegal drugs,cocaine, heroin, that kind of stuff.
You've got a woman who's trying to do her bestwho's a good mother to the child, who loves the child. Andmy hope will be the Judge will let us put Regina on thestand, and you'll get to see what a wonderful young lady sheis. And that's going to be your task. The stand is backhere in the courtroom. I pointed the wrong way. But you'llget to judge that credibility, and I want you to. I wantyou to hear from her, and I want you to see what kind ofgirl you sit in judgment on.
And that's the kind of evidence that we've got, sowhat happens? Why are we here? Suicide is an unfortunatething, but you can rightly say to me, "Lanier, what doesthat have to do with Pfizer? It sounds like it's got to dowith everything unfortunate in this woman's life, but howdoes Pfizer enter into the picture?"
Let me explain that to you. You're not asked asjurors to decide what the cause was of Susan Bulger'ssuicide. The issue that you're going to have before you iswhether or not the conduct from Pfizer and its predecessorcompany, conduct was outside the boundaries of what's rightand wrong based on what the Court tells you. You make that decision, and then you decide whether or not it was asignificant contributing cause.
There's a difference between something being thecause and a significant contributing cause. If you'rebaking bread even, you know, it rises in the oven --
MR. OHLEMEYER: Your Honor --
THE COURT: Overruled.
MR. LANIER: -- it rises in the oven because ofyeast, but it needs more than just the yeast. It needs themoisture and the food for the yeast. There are contributingcauses beyond just one sole cause in many events in life.And so you'll hear the evidence and a chance to decidewhether or not this drug was a significant contributingcause. And when you start reading that evidence or hearingthe evidence -- you'll get to read it because there aredocuments, as well as hear it from the witnesses, and maybefrom some videotapes that might play of witnesses that areunavailable -- you're going to hear an interesting, sordidtale.
I've told you a sordid tale about the Bulger life.Let me tell you the tale as it stems from this drug. It'sthe drug Neurontin. Some of you may have some familiaritywith it, some of you may not, but it's a fascinating story.The story starts with a drug company called Parke-Davis,which is actually the oldest pharmaceutical company in America. It was started in the 1800s right after the CivilWar. But Parke-Davis at the time that we're interested inis owned by Warner-Lambert, Warner-Lambert, the makers ofthings like Listerine and other things like that.
Warner-Lambert buys Parke-Davis in 1970, I believe. And soWarner-Lambert is the company.
Now, in this case we're suing Pfizer because inthe year 1999, effective, I think, January 1 of 2000, Pfizerbought Warner-Lambert and bought the right to Parke-Davis.So all of the issues that were part of Warner-Lambert arenow going to be part of Pfizer, and we'll look at that. AndPfizer, I think the Court will tell you, will ultimatelyhave the responsibility for the actions before as well asthe actions after that merger, and we'll look at both ofthem seamlessly. I sometimes will refer to it as Pfizer.That's just my shorthand way of not getting us all jumbledup, but I'll try to be as deliberate and careful as I can.It doesn't really make a legal difference, I guess is whatI'm driving at.
So you've got a company called Parke-Davis, adivision of Warner-Lambert. They discover a drug in theearly '90s that they call Neurontin. It's got a plainscientific name called gabapentin. And if you buy now ageneric version, for example, the pharmacist will sell yougabapentin, and you'll save some bucks. But Neurontin was the real name, and for the first, oh, ten years or so thedrug was sold there were no generics, so it was really justNeurontin. As long as the patent existed on the drug,nobody could make a generic.
And so you've got Neurontin. And before a companycan start selling a drug they invent, the company has to goto the Food and Drug Administration, the FDA. They have tosay, "FDA, we'd like to sell this drug," and the FDA says,"Well, show us what you want to do." And there's anelaborate, six-, seven-, eight-, ten-year process ofshepherding a drug through the FDA. And what the companyhas to do is say, "Here's what the drug is." You walkthrough animal testing, and then you walk through humantesting, and ultimately the FDA will either approve the drugand approve it for certain uses, the label, or the FDA won'tapprove the drug.
Now, the FDA might say, "We'll approve the drug,but you'd like the drug to work for all four of thesethings. We're only going to say it's approved for one."It's all a question of what the FDA chooses to do.The FDA did an evaluation of this drug, and as theFDA did an evaluation of the drug, they said, ultimately,"We're going to approve the drug, but we're going to approvethe drug as a second-line epileptic drug." A second line,what does that mean? It means doctors shouldn't use it as the primary drug. It shouldn't be the first go-to drugbecause it doesn't seem to work as well as the other drugson the market for epilepsy. But there may be circumstanceswhere the better-working drug doesn't work for a particularindividual, and in that situation, or maybe the best workingdrug would work better in tandem with Neurontin, it's asecond-line drug. It's a drug that can work along with, andit's approved for that in the epileptic market for epilepsy,for the convulsant type of seizures, a certain kind that areepileptic seizures. That's how the drug was approved.Before the actual approval goes out, the FDAsubmits -- and you're going to get a lot of exhibits. Idon't have many to show you during my opening because I wantyou to focus on the story. The documents you'll get fromthe witnesses, and we'll go through the documents in greatdetail. I think the documents are critically important.The problem is, anytime someone starts to show you adocument in the opening, you don't get the whole thing. Youget the snippets. See, I'm going to show you some snippetsfrom this document, and ultimately you need the wholedocument, you need witnesses so you can find out what's onthe pages I didn't show you to see if I was being fair andup front about it. So I'm careful about using documentswith you, but I do want to show you a couple of snippetsfrom this document.
MR. LANIER: Your Honor, with your permission, ifI could use the Elmo?
THE COURT: Yes. Now, for those of you sitting inthe back row, pull up -- it's like an airline tray tableright in between there. Pull it up. You all get screens.This is a high-tech courtroom. Pull it all up. And you'llbe using these a lot. I think for the public, is it workingback there?
MR. LANIER: Yes, your Honor, this screen is on.
THE COURT: That screen is on? Good, so everyonecan see?
MR. LANIER: Now, let's see if it's working.We'll ask it this way by putting something up.
THE COURT: Is everyone seeing? Yes, all right.
MR. LANIER: So, for example, this is a documentthat --
THE COURT: I just want to make sure, everybody'sscreen is up? Good, all right.
MR. LANIER: This document you'll see is from theDivision of Neuropharmacological Drug Products. This is acombined review that deals with the medical and thestatistical materials that Pfizer gave the FDA. It dealswith NDA, that means a new drug application, and it givesit. It's that drug Neurontin which has the name gabapentin.You're able to see that, I hope.
The snippets I want to show you from the review byMcCormack that was originally received January 31 of 1992,the snippets that I want to show you deal with the issue ofsuicide. Ultimately the question becomes, one of thequestions you've got to deal with is, does Lanier have anyevidence that Pfizer had a warning or had reason to warn, orreason to study, or reason to investigate, any reason at allthey might suspect this drug could have problems related tosuicide? And so we look at this document, and we're goingto see -- let's see if I can figure out how to make it alittle bigger.
These are a summary of the serious adverseevents that occurred in the gabapentin, which is Neurontin,treated patients. These are ones that are consideredpossibly or probably drug-related by the investigator.So they want to look and see what they are. Theyseparated them out. There's a category of "neurological."That's the epilepsy itself. Maybe this causes epilepsy orenhances it. They want to know.
They look, though, at an area called"psychiatric." Psychiatric means -- well, this is the areawe want to go to to question the issue of depression andsuicide and things like that. You'll see that they've gotthe number of each patient. They're going to have the ageand the gender, the dosage the patient is on and how longthe patient was on the drugs. They break all of that out.
But then they give information about the event.And so if we go over to the events, you'll seethat there was this one person who was depressed andattempted suicide. You'll see here's another person who wasdepressed. The depression resolved when they reduced thedose.
This was not treatment-emergent because they wantto note that the plaintiff had had depression in the past,so this wasn't the first time this patient was depressed.That's important. You don't know if the drug is causing it,or if the drug is bringing it back out, or if it's justthere and the drug is a coincidence.
There's another person who was depressed withsuicide ideation. That means they actually thought aboutkilling themselves. They improved on tapering. That means,as the drug was being removed from their system, they gotbetter. And they didn't have -- or the DC, anddiscontinuation. So their condition improved, but then thedepression with suicide ideation recurred on rechallenge.What that means is, you've got this person. They're takingthe drug. They're depressed. They've got suicide ideation.They're thinking about suicide. The doctor tapers them offthe drug, and as he does so, it goes away. And then he putsthem back on the drug, and it comes back.
You're going to hear evidence from some people that that is an absolute key test and a huge warning signthat the literature even writes up because it's very seriouswhen you have someone having a reaction they've never hadbefore when they're on the drug. They take them off thedrug; the reaction leaves. They put them back on the drug;the reaction comes back. They've got folks who tried todrug overdose. They've got people with depression andattempted suicide. They've got drug overdose. All of thisis happening before the drug has ever been approved.
Pfizer -- well, Warner-Lambert is what they werecalled at the time -- gets this information to the FDAbecause they're required under law to submit the NDA, thenew drug application. It's reams and reams and hundreds ofboxes' worth of material. They give all of this to the FDA,and the FDA works through it.
The FDA ultimately has what they call a section inhere entitled "Discussion of selected serious safetyfindings." Discussion of selected serious safety findings,and these are certain adverse events that emerged as bothserious and frequent. So we've got serious and we've gotfrequent adverse events. Due to the nature of the reportingprocess, it was initially difficult to determine themagnitude of these; therefore, how much of a safety issuethey represent. These include, the serious and frequentones include seizures and status, depression/suicide/ overdose, and cancers. And so the medical statisticalanalysis by the FDA gives us this indication, gives it outand gives it out early before the drug was even approved.
As we continue, they actually break out thoseserious events in sections. So there is a section for thedepression, the suicide ideation, which is idea, thinkingabout or contemplating, and the actual attempted suicide.It says, in the total exposed population -- that means outof everybody who's taken this drug in the study group -- 78of them, over 5 percent, 5.3 percent to be precise, of thepatients reported depression as an adverse event. Thisincluded one subject in a phase one study. There were sevenreports of depression as serious adverse events, and ninepatients who withdrew from the study because of depression.Now, they also go on to say that there may be someunderrepresentation of certain categories. It may not haveas many people as there actually were. It goes on. Forexample, in some cases depression was reported as a seriousadverse event, particularly if it resulted inhospitalization or was associated with suicide. You know,you go to the hospital because you're that depressed, theyreported it, or suicide ideation.
But, however, numerous examples were identifiedamong the CRFs -- those are the case reports -- where apatient developed treatment-emergent depression. That means depression that was oncoming after they started taking thedrug where pharmacological intervention was required, drugintervention, and a report of a serious adverse event wasnot made. In other words, we got 5.3 percent suffering thisproblem, but there may even be more.
If you get to the conclusions section of thisdocument as you work through it, or working toward theconclusions -- you'll see it on Page 117. It's where thesection is on the drug. It's conclusions for the toxicissues. It says it doesn't look like it's got hepatic --that's blood -- or bone marrow toxicity. In other words,it's not going to kill your bones or your bone marrow.
It says, "Less common but more serious events maylimit the drug's widespread usefulness." Now, these wordsare critical in this case. One of these is, "Seizures maybecome worse." It's what you're giving it for. A second ismalignancies. But look at the third.
A third is that "Depression, while it might not bean infrequent occurrence in the epileptic population --" inother words, epileptics probably are depressed anyway tosome degree "-- but it may become worse, and it may requireintervention, and it may lead to suicide, as it has resultedin some suicide attempts."
So this is the information that the drug companyhas that's issued by the FDA's review of their product back in 1992 before it's ever approved. What does the FDA do?Oh, they approved the product for epilepsy as a second-linetreatment. That's the key. They issue -- and they say,"Okay, look, guys --" and it makes sense. You'll hear theevidence about this. Epilepsy is a tough situation. Thereare not a lot of good drugs out there for epileptics, so theFDA is always tending to approve drugs that -- I think thatyou'll see that they will approve a drug more readily ifthere's a limited usefulness and there's not a lot of drugavailability. So, yes, they approved this drug. Andthey've got all the standard language that it's safe andappropriate for approved uses, blah-blah-blah, within thecaveats or the warnings or the exceptions that are provided.
What happens from here? Neurontin is approved forepilepsy. Warner-Lambert does an internal study trying tofigure out how much money they're going to make off thisdrug. So they do their market analysis, how big is themarket for epilepsy, and how much do you think we can make?And they figure that they're looking at making maybe$50 million a year, maybe not; maybe not that much, maybe alittle more. I think that sounds like a lot of money to us.If you take fifty of us, that gets us each $1 million, youknow, $50 million. But in the world of drugs, that's not abig one. It's not what they call a blockbuster. You've gotto top the billion-dollar mark for a blockbuster.
I'd love to show you the difference in stacks ofmoney between $50 million and a billion because it's a hugedifference. Okay, we just think in terms of the words andthey both sound like a lot of money, but, I mean, it's thedifference between a -- it's big. Do the math and you'lljust start -- it's lots of millions. It's a thousandmillions instead of fifty. It's the difference betweenhaving $50 and $1,000.
They have a market of $50 million, so they starttrying to figure out what they can do to expand the market.The drug company makes a conscious decision to do somethingthat is illegal. The law says the drug company can onlymarket the drug for its approved purposes. That law doesn'tapply to doctors. Doctors can write prescriptions all thetime for whatever the doctor thinks is appropriate, but thedrug company can't go out there and market and sell the drugfor what's called "off-label."
Important words, if youdon't mind me just writing them down for a minute."Off-label." Off-label marketing is "illegal."
Now, that may seem oversimplistic, and I'm nottrying to turn this into law school, but it's illegal. Youcan't do it. The drug companies can't do it, and they knowit.
The thing is, the drug company figures out there'sa world of people paying big dollars for drugs for things that Neurontin has not been approved for, but Neurontinfalls into this class of drugs called antiepileptic drugs,AED.
Anti, against, epileptic, epilepsy, drugs.
And somedoctors have used antiepileptic drugs before to help peoplewith pain. Well, that would be huge. The pain market isbig.
So what the drug company starts doing is making adeliberate effort to illegally market this drug off-label.I don't know what it is in your life, there's got to besomething in your life that relates this way to you. Thepicture I always get in my brain is from cartoons growingup. When I grew up, you remember we had the Bugs Bunny --some of you may be too young to remember that -- but theBugs Bunny cartoons and all of that? Have you ever seen thecartoon where they have the snowball that starts at the topof the hill and it starts rolling down, and as it gathersmomentum, it just gets bigger and bigger; and then, youknow, you've got arms and legs of people in the way flyingout and all, and it's gets on down the hill.
What the drug company does is makes aconscientious decision to market this off-label in a waywhere it takes on a life of its own, and it becomes amassive growing snowball that nothing really is going to getin the way and stop. They enter into an elaborateprogrammed plan to deliberately get doctors and people thinking that this drug is the wonder drug that will cureanything that ails you. There's actually a joke that's madeby the drug company bosses telling their salespeople to goout and sell the drug for a myriad of diseases. You know,we saw that it looks like it may cause depression, you sawthat in the document. They got their salespeople outtelling the doctors it's a cure for depression. It maycause different -- they've got them out there telling themit works for -- "Oh, write it for this, that."
In fact, thedrug company executives themselves say, "When you show thisnext slide to the doctors as you're selling them on it,you've got to warn them ahead of time, 'Hey, this looks likea snake oil salesman approach,' off of the old snake oilsalesmen, you know, that had the snake oil that was a curefor everything. They said, "Warn them. Otherwise, thedoctors when they see that we're claiming it might cure allthese things, they'll laugh you out of the room. But if youwarn them ahead of time and say, 'Hey, I look like a snakeoil salesman when I show you this next slide, but it's thetruth,' they won't laugh you out of the room."
Our first witness is a fellow named DavidFranklin, and we'll start him with the Court's permissionbefore today is over, but it will take through tomorrow tofinish him up with all the questions that we've got and thatthey've got.
David Franklin is an interesting fellow. He graduated with an undergraduate degree in microbiology fromthe University of Rhode Island. Then he gets his Ph.D. fromthere, and he's working at Dana Farber as a cancerresearcher and doing cancer work over at Dana Farber.He gets a job going to work for the drug company.
When he gets the job, he's being told -- now, he's not amedical doctor. You'll hear all about this. He's just aPh.D. He doesn't wear a stethoscope, he can't writeprescriptions, but gets hired at triple his former salary sothat on behalf of the drug company he can go into thedoctors' offices where he's introduced as a doctor, neverbeing told, well, not really a medical doctor. And he sitsthere and he's trained to teach these doctors and convincethese doctors to write prescriptions for Neurontin foroff-label reasons, to write prescriptions for Neurontin tocure ADD in children, to write prescriptions for Neurontinto do all sorts of different things. I'll ask him; you'llget to hear him.
He'll tell you that that wasn't the only thing;that the drug company also told him to go out there and toconvince the doctors to write what's called megadosing. Yousee, it's not enough that the drug company is going to tryand expand their profit margins by selling it off-label.The FDA only approves it in dosages up to, I think at thetime it was 1,800 milligrams, but the salespeople are told to go out there and to convince the doctors that they can donot 1,800. "Give them 21, give them 25, give them 28, givethem 31, give them 4,000, give them 4,800 a day, more andmore and more pills. Get it up as high as you can."
There's a joking memo about one woman who's on thedrug who winds up trying to commit suicide, and she's takenhundreds of them to try and do it, and the joke within thedrug company was, "That was the world's most expensivesuicide attempt." But they're pushing this drug in waysoutside the label and at dosages not approved.
Now, there are some restrictions on how they cando this and what they can do with the doctors. You, forexample, if you're a drug company are not allowed to pay adoctor to write a prescription, and aren't we glad?
Wouldn't you hate -- golden rule, excuse me, your Honor.It's a good thing that drug companies don't have the powerto pay doctors behind our back to write prescriptions forus. That's an important public health policy.
But the drugcompany found what they thought was a way around that. Theywould go to the doctors, and they would say, "Doctor, Ican't pay you to write a prescription, but I'll tell youwhat I can do. If you'll let me watch you write theprescription, we'll say that I'm learning from you. I'mlearning how you sign your name. I'm learning how you writea prescription. And I can pay you 350 bucks if you'll let me do that, watch you write the prescription. Be clear, I'mnot paying you for writing it. I'm paying for the honor oflearning how you do it."
Or, "Hey, Doctor, would you like to be a paidconsultant for our drug company? Here's what we're doing.We're going to have a phone conference coming up, and youcan participate as a paid consultant. We'll pay you 750bucks to be in on this phone conference. Now, if you wantto do it, though, the people on the conference areconsultants, and what that means is, you need to write acouple of Neurontin prescriptions so that on the phoneconference you can say that 'Hey, I've written someprescriptions,' and tell whether or not they're doing anygood. We'll pay you money to do that."
And then the drug company goes to these doctors.Now, they're not doing this to every doctor. The drugcompany has the information that enables them to know whichdoctors are writing the biggest number of prescriptions forpain, for depression, for all the different things they'relooking for. And they find those doctors, they target thosedoctors, and then they monitor through the record servicethat they have how many prescriptions that doctor is writingfor Neurontin versus other drugs. And so they keep veryclear tabs, and they target specific doctors.
Oh, they'll go to the doctors and say, "Doctors, we cannot pay you to write a prescription for Neurontin, butwould you like to come to a seminar? It will be anall-expense-paid trip for you and your family." Let's saythe Olympics were in Atlanta in 1996. "Why don't you comedown to Atlanta. We'll get you into some Olympic games.You can stay at the Chateau Elan," which is this wonderfulspa resort. I mean, it looks like a castle. "You can haveall the massages you want. Don't pay for a thing. Justwrite 'Parke-Davis' on the ticket. We'll pick up the tab.And then what you'll need to do is to sit in to an hour ortwo or three of doctors' presentations on how wonderful thedrug Neurontin is for reasons it's never been approved foroff-label."
I've got a list of things they did. I hadn'tcovered half of it. You're going to hear this from DavidFranklin. It's the effort to get that snowball rolling downthe hill with some momentum.
Oh, here's one. Doctors listen to other doctorsto get ideas on medicines, so the sales force was trained togo to one doctor and to say, you know, "Can I get you to doit?" And when that doctor does it, then they'd go to thenext doctor, almost like a door-to-door book salesman, thesame technique, and say, "Hey, Dr. Smith, you know,Dr. Jones down the hall, your buddy, he's writing theseNeurontin prescriptions, so excited about it. We want to give you a chance to get on the bandwagon too." And thenthey'd go to Dr. McDonald: "Dr. McDonald, Dr. Smith andJones, you know those two guys, they're doing this, and,man, this is the bandwagon you need." And they'd do thislike an intense spiderweb, you know, interweaving of all ofthe different doctors together.
Then that not being enough, they -- doctors notonly listen to other doctors, but doctors, some, read theliterature. So they're thinking, "How do we get in theliterature, the medical journals, information that says ourdrug is really good in all these areas where the FDA neversaid it was good? We didn't have enough proof for the FDAto get it approved for any of these areas, but how can weget the doctors to think it's good for them anyway? We needsome people to write some articles."
So what the drug company did is, they hire a PRfirm, and they figure out how to write these articles, andthen they go find doctors and they pay doctors to put thedoctor's name on the article so it can be published underthe doctor's name, with no reference to the PR firm or tothe drug company that really authored it. So they'reseeding the literature with that.
Now, I say seeding. "Seeding" has a buzz word intheir industry because they also did what's called a"seeding study," and they called it that internally. Please understand, you're not going to have a lot of documents onthis stuff because you will hear David Franklin explain thatthe people in his job, he was told, "Do not be putting muchof this stuff we're doing in writing." As one of thecoworkers said, "It just takes one phone call to turn us allin." They're not allowed to leave the slide, the snake oilsalesman slide, they're not allowed to leave thosepresentations with the doctors. They go to seminars wherethey're taught how to do this, and they're handed tablets,and across the tablets it says "Ladies and gentlemen of thejury" to remind them what kind of trouble the company canget in if people write stuff down. So any note that theywould take they would take understanding ultimately a jurymay get to see it one day. So a lot of what was done wasdone by phone, it was done face-to-face. Or there was atime where they were taught how to give a fair and balancedpresentation on a videotape. And so the videotape plays,and as the videotape plays, the executives stop thevideotape, and they say to everybody, "Okay, now, ignoreeverything you just heard, and let me tell you how we'regoing to do it. We were required to show you that."
This is what happens, and as it happens -- oh, theseeding study, I got distracted. Excuse me. The seedingstudy, what they do -- we think of studies, I hope, as thescientist writing and devising a very clear study with safety parameters. When somebody is in a study for a drug,an experimental study, we're supposed to have a fulldisclosure of what that study is for, and what are thepossible consequences, and that we have read it and weunderstand it and we're agreeing to be the guinea pig. Andthe scientists are supposed to set it out with very clearstandards so that the results can be very clear and can beadequately analyzed and calculated. That's the scientificprocess that should be producing these drugs to ourbenefits, or at least produce drugs that might benefit uswith a clear and fair warning so that we and our doctors canmake an adequate assessment of whether or not we want togamble and risk taking the drug.
No, they've got their marketing people devisingsome of their studies. The marketing people devised thestep study. This is one that they internally called a"seeding study" because it's like sewing seeds hoping forthat bumper crop. You know, the seeds off of one ear ofcorn ought to be able to produce enough to feed a family.They're going to seed, they're going to plant the seeds andjust watch it grow.
Here's what they did: They'd go find doctors andsay, "Doctors, would you like to participate in our stepstudy? You could be one of the doctors. Here's all youneed to do. Just put a couple of people, we'd like you to put ten, but put some people on Neurontin and keep up withthem for a period of time, and we'll pay you for each one ofthose people in the study. If at the end of the study youdecide Neurontin is helping them and you're going to keepthem on Neurontin, we'll pay you a bonus."
This is what the drug company would consider astudy, but it's not a study. That's not a fair, rigorousscientific study. Trust me, nobody signed a consent formsaying, "Yes, I'll take this drug knowing I'm a guinea pigby the marking department to see if they're going to be ableto sell more of these drugs by getting the doctors used towriting the prescriptions and the patients used to takingthe drugs," but that's what we have.
Now, David Franklin figures this out and afterfour months says "no" and quits. He's what's called awhistleblower. And he went out and he sought legal help,and he brought a complaint against at the timeWarner-Lambert. Pfizer buys them in the middle of thismess, and so we can start using the term "Pfizer" now. Andultimately Pfizer is fined and signs a guilty plea. Buttheir fine is 400 and some odd million dollars. Meanwhile,this drug has started selling billions of dollars. Justbetween the time Pfizer bought the company in 2000 and thetime that the drug goes off patent, Pfizer sells $10 billionof this drug, the drug that has a market of $50 million.
Oh, that market expanded.A couple of the tests that Pfizer did, orWarner-Lambert, showed that the drug might also have somepain relief help for a condition we call "shingles." Thedoctors call it "postherpetic neuropathy." Neuropathic painis a pain that's deemed to be part of the nerve system.You're doing the hook at fifteen after?
THE COURT: Yes.
MR. LANIER: Okay.
You're going to hear tons about this at a latertime, but I will tell you, I want to take advantage of thisformat to plug you into one more thing on that issue as Iget close to summing up, and that is, there is a whole areaof pain that's called "neuropathic pain." I'll abbreviateit as "neuropain," and it even gets that abbreviation in theindustry. They'll call it NP sometimes, neuropathic pain.One kind of neuropathic pain carries theabbreviation PHN. It's post, meaning after, herpetic, itcomes from herpes because it's the herpes virus of sorts,postherpetic neuropathy, or neuropain.
Now, that's one kind of neuropathic pain, andultimately the drug company is able to get approval forusing this drug Neurontin in that one area, that slim partof neuropathic pain, as well as in epilepsy, seizures. Now,that's it. That's all this drug ever gets approved for.
Boy, Pfizer takes it on the road. Look whatPfizer does. This is from Pfizer's 2001 U.S. operatingplan. And, again, I'm nervous about showing you an exhibitwhen you don't get to see the whole thing. I'll tell youwhy in a minute in more detail, but I can only show you alittle bit right now. I'll ask the Court to let this wholeexhibit go back into evidence.
The 2001 U.S. Operating Plan of Neurontin -- thisis by Pfizer at this point in time -- if we look on Page 503by the Bates number, your Honor, for the record, here's whatwe see: The medical strategic plan for Neurontin in 2001 isa neuropathic pain filing. They want to ask the FDA to letthem use it for neuropathic pain, but here are the tacticsthey're going to use. To get it for neuropathic pain,they're going to develop a relationship with the AmericanPain Society. They're going to publish and present new dataat key pain congresses. They're going to have a so-calledindependent group working. They're going to develop andpublish diagnostic tools. They're going to do things thattry to push this drug for the whole neuropathic paincategory, not simply folks suffering from shingles.And the drug company continues to do it. Theycontinue to sell this to people who never had epilepsy, whonever had shingles. That's the minor part of their market.The major part of the market is all this other stuff. They make a lot of money; they do a lot of damage. I think we'regoing to get into evidence some information where the FDAcontinued to monitor some things, and we'll be able to showyou that Pfizer themselves are guilty of marketing itoff-label illegally.
MR. OHLEMEYER: Objection, your Honor. There willbe no evidence of that.
THE COURT: As I said, this is not a substitutefor evidence.
MR. LANIER: And the Judge will throw me in jailif I say it's evidence because it's not. I think that'swhat the evidence will show. I think that's what you'llsea. You hold me accountable. You can write it down. If Ican't show it, I can't show it, but I think you'll see theevidence of it.
I think ultimately you're going to see the FDAfinally catches up and figures out what's going on becausethe FDA finally reports, the FDA finally says, "All of theseantiepileptic drugs, these eleven that we looked at, all ofthese seem to have some effect on depression and suicideideation and suicide." And the FDA ultimately will say,"Antiepileptic drugs are associated with increased risk ofsuicidality. The effect appears consistent among the groupof eleven drugs."
Oh, they're going to come in and say, "No, no, no, no, the FDA, they were a bit dim-witted on that. Theydidn't realize that these two drugs seemed to be the badguys and that we are innocent because ours wasn't." No,we'll sort through all of that. That's why we don't putdocuments up on a select basis. You've got to read thewhole document, and I'll put them in front of you, and we'llsort through them with witnesses, but beware of anyone whosays that --
MR. OHLEMEYER: I object to this, your Honor.It's not proper. It's argument.
THE COURT: Overruled. You have about five, sevenminutes.
MR. LANIER: Thank you, Judge.
And so Neurontin now, now, after the drug is offpatent, now that most people can buy it as gabapentin andbuy it outside, after they've made all of the big money thatthey're going to make on the drug, now the label is changed.And now Pfizer, now Pfizer, 2009, tells people that, "By theway, we still don't know how the drug works," and theydon't, just seems to, but under "Warnings," their first verybig warning is "suicidal behavior and ideation." They said,"Antiepileptic drugs, including Neurontin, increase the riskof suicidal thoughts or behavior in patients taking thesedrugs for any indication."
That warning should have been on there before. You'll hear the doctors that wrote these prescriptions.They had no idea. This was not being told. This is notwhat's being published. This is not the insight andinformation people are getting. It's not at all.So as you listen to me try and present thisevidence, you've got to integrate it with what you're goingto be hearing from these drug company lawyers becausethey've got their perspective that they want to give you. Ithink what you're going to hear and what I want you to sortthrough is evidence that tries to put all of the blame onthis on Susan Bulger.
I suspect you're not going to hear them accept oneounce of responsibility. I suspect they're going to say,"Hey, this woman was --" and they'll do it politely. Theywon't say "loser," but they're going to say this woman had,you know, such a horrible life, she was -- I'll tell youwhat. Every time they point out something bad about SusanBulger or a difficulty in her life, what that tells me is,this is the last person in the world who ought to be on adrug that increases suicide ideation. This is the lastperson in the world, especially, especially if one of thereasons her doctor is prescribing it is for depression.Mood disorder, affective mood disorder, that's one of thereasons the doctor is giving her the drug. He's hoping thisdrug will help treat the depression. Little does he know he's been beguiled by this world, and the drug is not goingto help treat the depression; it's going to make it worse.If the truth had been in the label, if the labelhad said what it should have said back when Susan Bulger wastaking it, the doctor would not have said, "Hey, you'redepressed. I understand from this massive snowball rollingdown the hill that Neurontin is good for depression. Let megive you some Neurontin. It will help." Instead maybe he'dhave given her some drugs that would have helped. I don'tknow, but he shouldn't be adding fuel to the fire. She'sthe last person in the world that ought to be taking thisdrug.
I think you'll hear from the defense side that theFDA approved the drug, so it must be safe. Well, they'vegot -- and I almost brought a deck of cards, but I didn'tdecide to use it, but if I took a deck of cards right here,and I held up the 3 of diamonds, and you look at it and say,"Hey, that's a diamond, isn't it?" and I put it down, and Iheld up the jack of diamonds and said, "That's a jack ofdiamonds," and then I set the whole deck of cards aside andI said, "Well, now we know that deck is full of diamonds,nothing else," you would laugh me out of the courtroom andsay, "Lanier, give me a break. You just showed us two ofthe cards."
What they're going to do is parade certain studies -- it's like parading certain pages of exhibits andleaving out other pages -- they're going to parade certainstudies in front of you that all seem to show this to be ajack of diamonds drug.
THE COURT: You need to finish in about threeminutes.
MR. LANIER: Okay, thank you, Judge.
And all I can say is just hold on and wait becauseit's my obligation and duty to show you the rest of the deckso that you know what all the cards are on the table, andthat's what my job is, and that's what I'll do.So the final thing I have to say in the last twominutes is, when you analyze this, don't ever be persuadedthat you're trying to look for the cause of the suicide.The question is, in the great wealth of the world, was thisdrug a significant contributing cause? Was it a significantcontributing cause, not was it the cause? The cause is waytoo complicated.
So those are what I anticipate the trial is goingto unfold, both the themes that the parties will have aswell as how we're going to approach it. We're going to doit through witnesses. We'll try and do it as quickly aspossible. We've got a number of lawyers working on thecase, and we'll see how it all shakes out. But weappreciate very much your time and attention, and I look forward to getting to know you, indirectly, over the nextcouple of weeks.
Thank you, your Honor.