decoration decoration

When you want to know more...
For layout only
Site Map
About Groklaw
Legal Research
ApplevSamsung p.2
Cast: Lawyers
Comes v. MS
Gordon v MS
IV v. Google
Legal Docs
MS Litigations
News Picks
Novell v. MS
Novell-MS Deal
OOXML Appeals
Quote Database
Red Hat v SCO
Salus Book
SCEA v Hotz
SCO Appeals
SCO Bankruptcy
SCO Financials
SCO Overview
SCO v Novell
Sean Daly
Software Patents
Switch to Linux
Unix Books
Your contributions keep Groklaw going.
To donate to Groklaw 2.0:

Groklaw Gear

Click here to send an email to the editor of this weblog.

To read comments to this article, go here
A Fine Kettle of Pfizer Fish - Updated 3Xs
Tuesday, August 11 2009 @ 07:56 AM EDT

Here's a fine kettle of fish. Pfizer's lawyers hired a detective who ended up intimidating a witness the day before he was due to testify, according to this 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?

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.

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.

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 -

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.

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.

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.

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.

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.

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.


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.)

Franklin then takes the stand, and he tells what happened the day before:
MR. LANIER: Your Honor, the plaintiffs at this time would call Dr. Dave Franklin to the stand.

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.

Q. Okay.

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 standing at 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 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.

A. Okay.

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 as 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.

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:
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.

That is when he went to talk to Thomas M. Greene, a lawyer in Boston, and soon filed the lawsuit.

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:
THE COURT: But let me just, there's one other issue. Is Dr. Franklin here?


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.

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:

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.
There 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:
He said the detective was hired to ask Franklin if he planned to testify and what he would say, a common practice during trials.

"It sounds like this didn't happen the way it should have happened," Ohlemeyer said. "We apologized to (Franklin) for what happened."

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.

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:

  • 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.
See what bothers me about this story?

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.

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.

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.

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."

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.

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.

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.

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.

There's a browsable Drug Industry Document Archive at the U. of California, San Francisco, made possible by that trial:
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.

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.

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.

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 some pharmaceutical marketing may be less opaque, deceptive, and manipulative, evidence indicates that drug promotion can corrupt the science, teaching, and practice of medicine.

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.

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.

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 fill out the IRF so that they would be covered . However, when asked if sales representatives could sign the IRFs instead of the physician, Jim Parker stated that the FDA would see that as a forgery . In a conversation on July 1, 1996 with Dr . Franklin and John Krukor, Phil Magistro said "I checked with people way over Jim Parker's head 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 I mean, these things are low priority, if something happens then we'll produce (laugh) what they want, don't worry." Krukar added, "In fact', I wish you guys would stop asking about this stuff, it just makes everybody anxious. If you guys are that anal you should rethink 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 out forms for a living, get a state job."

In the entire time Dr. Franklin worked for Parke-Davis, he never possessed a Physician Information Request Form.

This is the company whose lawyers now accuse Dr. Franklin of making up stories to get media attention. Who ya gonna believe?

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 2: In April of 2010, there was a study that found Nerontin, as well as other anticonvulsive drugs, raise the risk of suicide.

Update 3: In December of 2010, allegations surfaced that Pfizer hired investigators to dig up dirt on the then-attorney general of Nigeria to pressure him to drop litigation brought against the company for testing a drug without parental knowledge on children there.

Update: Here's Mr. Lanier's opening statement, followed by Mr. Ohlemeyer's, as text, and as you read them, I think you'll see that despite the brilliance of Mr. Lanier's performance, there was no need to send any intimidation to deal with Dr. Franklin, if that happened, as the facts were more on Mr. Ohlemeyer's side, and he has the skill to handle whatever the other side presented without the need for any English on the ball. But to me the most interesting thing to notice is how each of these attorneys handle an identical problem -- namely, that the jury might really dislike their client:



MR. LANIER: May it please the Court, good morning, ladies and gentlemen. My name is Mark Lanier. It's my honor today and throughout this trial to some degree, at least, to be able to represent Regina Bulger. Regina, would you stand up so they know who you are, please. She's that sweet little ten-year-old right there, who's just finished fourth grade and is starting fifth grade in the fall. She's in the summer. She's lives with her grandmother, Grandma Pat. Would you stand up, please, and let them know who you are. And they won't be here for very much of the trial. In fact, I'm going to ask them to leave, if you don't mind, at this point now that the jury has seen you, and thank you all for coming down here this morning.

You'll get to know more about them and you'll get to know more about why they leave as -- this gentleman who's standing up now is Dr. David Egilman. He teaches at Brown and is a doctor nearby, and is the legal representative for purposes of this lawsuit of the young lady that you've just seen, Regina. Thank you, Dr. Egilman.

This is a simple case, but it's a very serious case. It's a very serious case because it involves some delicate issues, but it involves some important policy issues 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 point are actually doing something that's extremely important as you make your way through this case. And what I get to do over the next 57 minutes at this point before I get the hook is, I get to tell you what I anticipate the evidence is going to be.

It's a case that evolves ultimately around that young girl from here on out, but she's not the main character in the past part of the story. The past part of this story involves her mother, Susan Bulger. Susan committed suicide, and it will be five years ago next week on August 4. Regina and her father, Ron, Sr., are who found the mom dangling at the end of a wire in the basement.

It's a tough, tough thing when you're dealing with suicide. Suicide is not a simple matter. And we're going to have to probe in this case, what is it that allows a person to kill themselves? It's not something that's common in the United States. Oh, it happens, and I think most of us, the older we get, we can find where we've brushed up with awareness of it somewhere in our life, but what is it that happens?

You know, the way we're made, the doctors will explain, we've got within us kind of a wall of self-preservation. There's this will that says, "I don't want to stick my hand in fire. You know, it's going to burn, it's going to hurt. I don't want to do damage and destruction to my body."

Now, some people have, some doctors call it the will to live. Some people have a really strong will to live. You probably heard stories about people the doctors thought were going to die in the hospital, but they just seemed to hang on. And doctors might say they have a strong will 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 people have a bigger wall than others, some people have a really strong will to live. Some folks, their will to live is not as strong. Some people have a very low wall, and those people are people who are susceptible to, in danger of something that might hurt themselves, some type of a suicide.

The evidence in this case is going to show you that 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 her verbally. They may have abused her physically. I don't know. But early in her life she got hooked up with a fellow named Ron Bulger. He wasn't the kind of guy that most parents want their daughters to hook up with, a tough husband. And so she's in a marriage where her husband is a drug user. He used illegal drugs, cocaine, heroin, a number of different illegal drugs.

Susan Bulger herself lived a very tough life, did many of the same things as her husband. She found herself addicted at one point in life to cocaine. She found herself addicted at one point in life to heroin. She tried to, maybe -- I mean, this is some degree of speculation, but she clearly tried to at least hurt herself and gain attention, if not actually try to commit suicide, multiple times in her life 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 early twenties. I don't have him down here. You'll understand why more and more as we go through the trial. You'll understand my concern, and what you're going to hear my evidence point to is what we need to do for this young lady and not really for the husband --

MR. OHLEMEYER: Objection, your Honor.

THE COURT: Overruled.

MR. LANIER: Not for the husband, and not even for Ron, Jr., the older brother. So the evidence is going to be targeted around the young lady, around Regina, and what I believe have been her damages and what we need to do to take care of her and keep her on a road to a good life that she's on right now.

As we look at this, though, you're going to see that the mom, Susan, and the dad, Ron, Sr., they had a son, this older brother. Susan tried hard to be a good mom. I'm sure Ron, Sr. tried hard to be a good dad. There were limits to how good they were. They were young for that child, and they had struggles. They lost custody of the child for a while because of the drug abuse in their home. It's a sad situation to sit and learn from.

If you take that social sadness, add to it -- let me add another layer now. There's not just social sadness in her life. There are lots of other physical problems she had. Susan Bulger, the mom, had rheumatoid arthritis, painful advanced rheumatoid arthritis. She had fifteen, sixteen, seventeen surgeries in her life. She lost all but four of her teeth. She had just had an elbow surgery within a few years of her suicide. She had aches and pains that required her 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 of medicines she'd been on all of her life.

At the time she committed suicide, she's on maybe five or six medicines, but over her life she'd been on a ton of them to try and deal with the pain. She was on methadone at the time of her suicide simply for pain relief. I think she was out of tablets at the time, so she was clearly hurting actually.

But this is a woman who had physical pain. She had emotional difficulties from childhood. This is a woman who had a tough marriage. She'd been talking to some people about leaving her husband. But she had a bright spot in her life, and the bright spot was that little girl she named Regina. It's Latin for "queen."

I think the evidence is going to show you that in some way, with the pregnancy of Regina, Susan Bulger tried to turn her life around. She went onto methadone and some other drugs while she was pregnant so she wouldn't be using heroin. She did what she could do to try and make sure she didn't lose this child the way she'd lost her son. You don't -- you know, there's the old expression, "You don't turn a battle ship on a dime." Well, you don't turn your life around generally -- I know historically there have been a few roads to Damascus, but you don't generally turn a life around on a dime. But you'll clearly see that there were efforts 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 best who's a good mother to the child, who loves the child. And my hope will be the Judge will let us put Regina on the stand, and you'll get to see what a wonderful young lady she is. And that's going to be your task. The stand is back here in the courtroom. I pointed the wrong way. But you'll get to judge that credibility, and I want you to. I want you to hear from her, and I want you to see what kind of girl you sit in judgment on.

And that's the kind of evidence that we've got, so what happens? Why are we here? Suicide is an unfortunate thing, but you can rightly say to me, "Lanier, what does that have to do with Pfizer? It sounds like it's got to do with everything unfortunate in this woman's life, but how does Pfizer enter into the picture?"

Let me explain that to you. You're not asked as jurors to decide what the cause was of Susan Bulger's suicide. The issue that you're going to have before you is whether or not the conduct from Pfizer and its predecessor company, conduct was outside the boundaries of what's right and wrong based on what the Court tells you. You make that decision, and then you decide whether or not it was a significant contributing cause.

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 --

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. And when you start reading that evidence or hearing the evidence -- you'll get to read it because there are documents, as well as hear it from the witnesses, and maybe from some videotapes that might play of witnesses that are unavailable -- you're going to hear an interesting, sordid tale.

I've told you a sordid tale about the Bulger life. Let me tell you the tale as it stems from this drug. It's the drug Neurontin. Some of you may have some familiarity with 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 Civil War. But Parke-Davis at the time that we're interested in is owned by Warner-Lambert, Warner-Lambert, the makers of things like Listerine and other things like that.

Warner-Lambert buys Parke-Davis in 1970, I believe. And so Warner-Lambert is the company.

Now, in this case we're suing Pfizer because in the year 1999, effective, I think, January 1 of 2000, Pfizer bought Warner-Lambert and bought the right to Parke-Davis. So all of the issues that were part of Warner-Lambert are now going to be part of Pfizer, and we'll look at that. And Pfizer, I think the Court will tell you, will ultimately have the responsibility for the actions before as well as the actions after that merger, and we'll look at both of them seamlessly. I sometimes will refer to it as Pfizer. That's just my shorthand way of not getting us all jumbled up, but I'll try to be as deliberate and careful as I can. It doesn't really make a legal difference, I guess is what I'm driving at.

So you've got a company called Parke-Davis, a division of Warner-Lambert. They discover a drug in the early '90s that they call Neurontin. It's got a plain scientific name called gabapentin. And if you buy now a generic version, for example, the pharmacist will sell you gabapentin, and you'll save some bucks. But Neurontin was the real name, and for the first, oh, ten years or so the drug was sold there were no generics, so it was really just Neurontin. As long as the patent existed on the drug, nobody could make a generic.

And so you've got Neurontin. And before a company can start selling a drug they invent, the company has to go to the Food and Drug Administration, the FDA. They have to say, "FDA, we'd like to sell this drug," and the FDA says, "Well, show us what you want to do." And there's an elaborate, six-, seven-, eight-, ten-year process of shepherding a drug through the FDA. And what the company has to do is say, "Here's what the drug is." You walk through animal testing, and then you walk through human testing, and ultimately the FDA will either approve the drug and approve it for certain uses, the label, or the FDA won't approve the drug.

Now, the FDA might say, "We'll approve the drug, but you'd like the drug to work for all four of these things. 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 the FDA did an evaluation of the drug, they said, ultimately, "We're going to approve the drug, but we're going to approve the 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 drug because it doesn't seem to work as well as the other drugs on the market for epilepsy. But there may be circumstances where the better-working drug doesn't work for a particular individual, and in that situation, or maybe the best working drug would work better in tandem with Neurontin, it's a second-line drug. It's a drug that can work along with, and it's approved for that in the epileptic market for epilepsy, for the convulsant type of seizures, a certain kind that are epileptic seizures. That's how the drug was approved. Before the actual approval goes out, the FDA submits -- and you're going to get a lot of exhibits. I don't have many to show you during my opening because I want you to focus on the story. The documents you'll get from the witnesses, and we'll go through the documents in great detail. I think the documents are critically important. The problem is, anytime someone starts to show you a document in the opening, you don't get the whole thing. You get the snippets. See, I'm going to show you some snippets from this document, and ultimately you need the whole document, you need witnesses so you can find out what's on the pages I didn't show you to see if I was being fair and up front about it. So I'm careful about using documents with you, but I do want to show you a couple of snippets from this document.

MR. LANIER: Your Honor, with your permission, if I could use the Elmo?

THE COURT: Yes. Now, for those of you sitting in the back row, pull up -- it's like an airline tray table right in between there. Pull it up. You all get screens. This is a high-tech courtroom. Pull it all up. And you'll be using these a lot. I think for the public, is it working back there?

MR. LANIER: Yes, your Honor, this screen is on.

THE COURT: That screen is on? Good, so everyone can 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 document that --

THE COURT: I just want to make sure, everybody's screen is up? Good, all right.

MR. LANIER: This document you'll see is from the Division of Neuropharmacological Drug Products. This is a combined review that deals with the medical and the statistical materials that Pfizer gave the FDA. It deals with NDA, that means a new drug application, and it gives it. 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 by McCormack that was originally received January 31 of 1992, the snippets that I want to show you deal with the issue of suicide. Ultimately the question becomes, one of the questions you've got to deal with is, does Lanier have any evidence that Pfizer had a warning or had reason to warn, or reason to study, or reason to investigate, any reason at all they might suspect this drug could have problems related to suicide? And so we look at this document, and we're going to see -- let's see if I can figure out how to make it a little bigger.

These are a summary of the serious adverse events that occurred in the gabapentin, which is Neurontin, treated patients. These are ones that are considered possibly or probably drug-related by the investigator. So they want to look and see what they are. They separated them out. There's a category of "neurological." That's the epilepsy itself. Maybe this causes epilepsy or enhances it. They want to know.

They look, though, at an area called "psychiatric." Psychiatric means -- well, this is the area we want to go to to question the issue of depression and suicide and things like that. You'll see that they've got the number of each patient. They're going to have the age and the gender, the dosage the patient is on and how long the 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 see that there was this one person who was depressed and attempted suicide. You'll see here's another person who was depressed. The depression resolved when they reduced the dose.

This was not treatment-emergent because they want to 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 just there and the drug is a coincidence.

There's another person who was depressed with suicide ideation. That means they actually thought about killing themselves. They improved on tapering. That means, as the drug was being removed from their system, they got better. And they didn't have -- or the DC, and discontinuation. So their condition improved, but then the depression with suicide ideation recurred on rechallenge. What that means is, you've got this person. They're taking the drug. They're depressed. They've got suicide ideation. They're thinking about suicide. The doctor tapers them off the drug, and as he does so, it goes away. And then he puts them 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 sign that the literature even writes up because it's very serious when you have someone having a reaction they've never had before when they're on the drug. They take them off the drug; the reaction leaves. They put them back on the drug; the reaction comes back. They've got folks who tried to drug overdose. They've got people with depression and attempted suicide. They've got drug overdose. All of this is happening before the drug has ever been approved.

Pfizer -- well, Warner-Lambert is what they were called at the time -- gets this information to the FDA because they're required under law to submit the NDA, the new drug application. It's reams and reams and hundreds of boxes' 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 in here entitled "Discussion of selected serious safety findings." Discussion of selected serious safety findings, and these are certain adverse events that emerged as both serious and frequent. So we've got serious and we've got frequent adverse events. Due to the nature of the reporting process, it was initially difficult to determine the magnitude of these; therefore, how much of a safety issue they represent. These include, the serious and frequent ones include seizures and status, depression/suicide/ overdose, and cancers. And so the medical statistical analysis by the FDA gives us this indication, gives it out and gives it out early before the drug was even approved.

As we continue, they actually break out those serious events in sections. So there is a section for the depression, the suicide ideation, which is idea, thinking about or contemplating, and the actual attempted suicide. It says, in the total exposed population -- that means out of everybody who's taken this drug in the study group -- 78 of them, over 5 percent, 5.3 percent to be precise, of the patients reported depression as an adverse event. This included one subject in a phase one study. There were seven reports of depression as serious adverse events, and nine patients who withdrew from the study because of depression. Now, they also go on to say that there may be some underrepresentation of certain categories. It may not have as many people as there actually were. It goes on. For example, in some cases depression was reported as a serious adverse event, particularly if it resulted in hospitalization or was associated with suicide. You know, you go to the hospital because you're that depressed, they reported it, or suicide ideation.

But, however, numerous examples were identified among the CRFs -- those are the case reports -- where a patient developed treatment-emergent depression. That means depression that was oncoming after they started taking the drug where pharmacological intervention was required, drug intervention, and a report of a serious adverse event was not made. In other words, we got 5.3 percent suffering this problem, but there may even be more.

If you get to the conclusions section of this document as you work through it, or working toward the conclusions -- you'll see it on Page 117. It's where the section is on the drug. It's conclusions for the toxic issues. 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 may limit the drug's widespread usefulness." Now, these words are critical in this case. One of these is, "Seizures may become worse." It's what you're giving it for. A second is malignancies. But look at the third.

A third is that "Depression, while it might not be an infrequent occurrence in the epileptic population --" in other words, epileptics probably are depressed anyway to some degree "-- but it may become worse, and it may require intervention, and it may lead to suicide, as it has resulted in some suicide attempts."

So this is the information that the drug company has 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-line treatment. That's the key. They issue -- and they say, "Okay, look, guys --" and it makes sense. You'll hear the evidence about this. Epilepsy is a tough situation. There are not a lot of good drugs out there for epileptics, so the FDA is always tending to approve drugs that -- I think that you'll see that they will approve a drug more readily if there's a limited usefulness and there's not a lot of drug availability. So, yes, they approved this drug. And they've got all the standard language that it's safe and appropriate for approved uses, blah-blah-blah, within the caveats or the warnings or the exceptions that are provided.

What happens from here? Neurontin is approved for epilepsy. Warner-Lambert does an internal study trying to figure out how much money they're going to make off this drug. So they do their market analysis, how big is the market 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 a little more. I think that sounds like a lot of money to us. If you take fifty of us, that gets us each $1 million, you know, $50 million. But in the world of drugs, that's not a big one. It's not what they call a blockbuster. You've got to top the billion-dollar mark for a blockbuster.

I'd love to show you the difference in stacks of money between $50 million and a billion because it's a huge difference. Okay, we just think in terms of the words and they both sound like a lot of money, but, I mean, it's the difference between a -- it's big. Do the math and you'll just start -- it's lots of millions. It's a thousand millions instead of fifty. It's the difference between having $50 and $1,000.

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."

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. There's actually a joke that's made by the drug company bosses telling their salespeople to go out and sell the drug for a myriad of diseases. You know, we saw that it looks like it may cause depression, you saw that in the document. They got their salespeople out telling the doctors it's a cure for depression. It may cause different -- they've got them out there telling them it works for -- "Oh, write it for this, that."

In fact, the drug company executives themselves say, "When you show this next slide to the doctors as you're selling them on it, you've got to warn them ahead of time, 'Hey, this looks like a snake oil salesman approach,' off of the old snake oil salesmen, you know, that had the snake oil that was a cure for everything. They said, "Warn them. Otherwise, the doctors when they see that we're claiming it might cure all these things, they'll laugh you out of the room. But if you warn them ahead of time and say, 'Hey, I look like a snake oil salesman when I show you this next slide, but it's the truth,' they won't laugh you out of the room."

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, watch you write the prescription. Be clear, I'm not paying you for writing it. I'm paying for the honor of learning how you do it."

Or, "Hey, Doctor, would you like to be a paid consultant for our drug company? Here's what we're doing. We're going to have a phone conference coming up, and you can participate as a paid consultant. We'll pay you 750 bucks to be in on this phone conference. Now, if you want to do it, though, the people on the conference are consultants, and what that means is, you need to write a couple of Neurontin prescriptions so that on the phone conference you can say that 'Hey, I've written some prescriptions,' and tell whether or not they're doing any good. 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 drug company has the information that enables them to know which doctors are writing the biggest number of prescriptions for pain, for depression, for all the different things they're looking for. And they find those doctors, they target those doctors, and then they monitor through the record service that they have how many prescriptions that doctor is writing for Neurontin versus other drugs. And so they keep very clear 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, but would you like to come to a seminar? It will be an all-expense-paid trip for you and your family." Let's say the Olympics were in Atlanta in 1996. "Why don't you come down to Atlanta. We'll get you into some Olympic games. You can stay at the Chateau Elan," which is this wonderful spa resort. I mean, it looks like a castle. "You can have all the massages you want. Don't pay for a thing. Just write '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 or two or three of doctors' presentations on how wonderful the drug Neurontin is for reasons it's never been approved for off-label."

I've got a list of things they did. I hadn't covered half of it. You're going to hear this from David Franklin. It's the effort to get that snowball rolling down the hill with some momentum.

Oh, here's one. Doctors listen to other doctors to get ideas on medicines, so the sales force was trained to go to one doctor and to say, you know, "Can I get you to do it?" And when that doctor does it, then they'd go to the next doctor, almost like a door-to-door book salesman, the same technique, and say, "Hey, Dr. Smith, you know, Dr. Jones down the hall, your buddy, he's writing these Neurontin prescriptions, so excited about it. We want to give you a chance to get on the bandwagon too." And then they'd go to Dr. McDonald: "Dr. McDonald, Dr. Smith and Jones, you know those two guys, they're doing this, and, man, this is the bandwagon you need." And they'd do this like an intense spiderweb, you know, interweaving of all of the different doctors together.

Then that not being enough, they -- doctors not only listen to other doctors, but doctors, some, read the literature. So they're thinking, "How do we get in the literature, the medical journals, information that says our drug is really good in all these areas where the FDA never said it was good? We didn't have enough proof for the FDA to get it approved for any of these areas, but how can we get the doctors to think it's good for them anyway? We need some people to write some articles."

So what the drug company did is, they hire a PR firm, and they figure out how to write these articles, and then they go find doctors and they pay doctors to put the doctor's name on the article so it can be published under the doctor's name, with no reference to the PR firm or to the drug company that really authored it. So they're seeding the literature with that.

Now, I say seeding. "Seeding" has a buzz word in their 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 on this stuff because you will hear David Franklin explain that the people in his job, he was told, "Do not be putting much of this stuff we're doing in writing." As one of the coworkers said, "It just takes one phone call to turn us all in." They're not allowed to leave the slide, the snake oil salesman slide, they're not allowed to leave those presentations with the doctors. They go to seminars where they're taught how to do this, and they're handed tablets, and across the tablets it says "Ladies and gentlemen of the jury" to remind them what kind of trouble the company can get in if people write stuff down. So any note that they would take they would take understanding ultimately a jury may get to see it one day. So a lot of what was done was done by phone, it was done face-to-face. Or there was a time where they were taught how to give a fair and balanced presentation on a videotape. And so the videotape plays, and as the videotape plays, the executives stop the videotape, and they say to everybody, "Okay, now, ignore everything you just heard, and let me tell you how we're going to do it. We were required to show you that."

This is what happens, and as it happens -- oh, the seeding study, I got distracted. Excuse me. The seeding study, what they do -- we think of studies, I hope, as the scientist 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 full disclosure of what that study is for, and what are the possible consequences, and that we have read it and we understand it and we're agreeing to be the guinea pig. And the scientists are supposed to set it out with very clear standards so that the results can be very clear and can be adequately analyzed and calculated. That's the scientific process that should be producing these drugs to our benefits, or at least produce drugs that might benefit us with a clear and fair warning so that we and our doctors can make an adequate assessment of whether or not we want to gamble and risk taking the drug.

No, they've got their marketing people devising some of their studies. The marketing people devised the step study. This is one that they internally called a "seeding study" because it's like sewing seeds hoping for that bumper crop. You know, the seeds off of one ear of corn ought to be able to produce enough to feed a family. They're going to seed, they're going to plant the seeds and just watch it grow.

Here's what they did: They'd go find doctors and say, "Doctors, would you like to participate in our step study? You could be one of the doctors. Here's all you need to do. Just put a couple of people, we'd like you to put ten, but put some people on Neurontin and keep up with them for a period of time, and we'll pay you for each one of those people in the study. If at the end of the study you decide Neurontin is helping them and you're going to keep them on Neurontin, we'll pay you a bonus."

This is what the drug company would consider a study, but it's not a study. That's not a fair, rigorous scientific study. Trust me, nobody signed a consent form saying, "Yes, I'll take this drug knowing I'm a guinea pig by the marking department to see if they're going to be able to sell more of these drugs by getting the doctors used to writing the prescriptions and the patients used to taking the drugs," but that's what we have.

Now, David Franklin figures this out and after four months says "no" and quits. He's what's called a whistleblower. And he went out and he sought legal help, and he brought a complaint against at the time Warner-Lambert. Pfizer buys them in the middle of this mess, and so we can start using the term "Pfizer" now. And ultimately Pfizer is fined and signs a guilty plea. But their fine is 400 and some odd million dollars. Meanwhile, this drug has started selling billions of dollars. Just between the time Pfizer bought the company in 2000 and the time that the drug goes off patent, Pfizer sells $10 billion of this drug, the drug that has a market of $50 million.

Oh, that market expanded. A couple of the tests that Pfizer did, or Warner-Lambert, showed that the drug might also have some pain relief help for a condition we call "shingles." The doctors call it "postherpetic neuropathy." Neuropathic pain is a pain that's deemed to be part of the nerve system. You're doing the hook at fifteen after?



You're going to hear tons about this at a later time, but I will tell you, I want to take advantage of this format to plug you into one more thing on that issue as I get close to summing up, and that is, there is a whole area of pain that's called "neuropathic pain." I'll abbreviate it as "neuropain," and it even gets that abbreviation in the industry. They'll call it NP sometimes, neuropathic pain. One kind of neuropathic pain carries the abbreviation PHN. It's post, meaning after, herpetic, it comes from herpes because it's the herpes virus of sorts, postherpetic neuropathy, or neuropain.

Now, that's one kind of neuropathic pain, and ultimately the drug company is able to get approval for using this drug Neurontin in that one area, that slim part of 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 what Pfizer does. This is from Pfizer's 2001 U.S. operating plan. And, again, I'm nervous about showing you an exhibit when you don't get to see the whole thing. I'll tell you why in a minute in more detail, but I can only show you a little bit right now. I'll ask the Court to let this whole exhibit go back into evidence.

The 2001 U.S. Operating Plan of Neurontin -- this is by Pfizer at this point in time -- if we look on Page 503 by the Bates number, your Honor, for the record, here's what we see: The medical strategic plan for Neurontin in 2001 is a neuropathic pain filing. They want to ask the FDA to let them use it for neuropathic pain, but here are the tactics they're going to use. To get it for neuropathic pain, they're going to develop a relationship with the American Pain Society. They're going to publish and present new data at key pain congresses. They're going to have a so-called independent group working. They're going to develop and publish diagnostic tools. They're going to do things that try to push this drug for the whole neuropathic pain category, not simply folks suffering from shingles. And the drug company continues to do it. They continue to sell this to people who never had epilepsy, who never 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're going to get into evidence some information where the FDA continued to monitor some things, and we'll be able to show you that Pfizer themselves are guilty of marketing it off-label illegally.

MR. OHLEMEYER: Objection, your Honor. There will be no evidence of that.

THE COURT: As I said, this is not a substitute for evidence.

MR. LANIER: And the Judge will throw me in jail if I say it's evidence because it's not. I think that's what the evidence will show. I think that's what you'll sea. You hold me accountable. You can write it down. If I can't show it, I can't show it, but I think you'll see the evidence of it.

I think ultimately you're going to see the FDA finally catches up and figures out what's going on because the FDA finally reports, the FDA finally says, "All of these antiepileptic drugs, these eleven that we looked at, all of these seem to have some effect on depression and suicide ideation and suicide." And the FDA ultimately will say, "Antiepileptic drugs are associated with increased risk of suicidality. The effect appears consistent among the group of 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. They didn't realize that these two drugs seemed to be the bad guys and that we are innocent because ours wasn't." No, we'll sort through all of that. That's why we don't put documents up on a select basis. You've got to read the whole document, and I'll put them in front of you, and we'll sort through them with witnesses, but beware of anyone who says that --

MR. OHLEMEYER: I object to this, your Honor. It's not proper. It's argument.

THE COURT: Overruled. You have about five, seven minutes.

MR. LANIER: Thank you, Judge.

And so Neurontin now, now, after the drug is off patent, now that most people can buy it as gabapentin and buy it outside, after they've made all of the big money that they're going to make on the drug, now the label is changed. And now Pfizer, now Pfizer, 2009, tells people that, "By the way, we still don't know how the drug works," and they don't, just seems to, but under "Warnings," their first very big warning is "suicidal behavior and ideation." They said, "Antiepileptic drugs, including Neurontin, increase the risk of suicidal thoughts or behavior in patients taking these drugs 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 not what's being published. This is not the insight and information people are getting. It's not at all. So as you listen to me try and present this evidence, you've got to integrate it with what you're going to be hearing from these drug company lawyers because they've got their perspective that they want to give you. I think what you're going to hear and what I want you to sort through is evidence that tries to put all of the blame on this on Susan Bulger.

I suspect you're not going to hear them accept one ounce of responsibility. I suspect they're going to say, "Hey, this woman was --" and they'll do it politely. They won't say "loser," but they're going to say this woman had, you know, such a horrible life, she was -- I'll tell you what. Every time they point out something bad about Susan Bulger or a difficulty in her life, what that tells me is, this is the last person in the world who ought to be on a drug that increases suicide ideation. This is the last person in the world, especially, especially if one of the reasons her doctor is prescribing it is for depression. Mood disorder, affective mood disorder, that's one of the reasons the doctor is giving her the drug. He's hoping this drug will help treat the depression. Little does he know he's been beguiled by this world, and the drug is not going to help treat the depression; it's going to make it worse. If the truth had been in the label, if the label had said what it should have said back when Susan Bulger was taking it, the doctor would not have said, "Hey, you're depressed. I understand from this massive snowball rolling down the hill that Neurontin is good for depression. Let me give you some Neurontin. It will help." Instead maybe he'd have given her some drugs that would have helped. I don't know, but he shouldn't be adding fuel to the fire. She's the last person in the world that ought to be taking this drug.

I think you'll hear from the defense side that the FDA approved the drug, so it must be safe. Well, they've got -- and I almost brought a deck of cards, but I didn't decide 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 I held up the jack of diamonds and said, "That's a jack of diamonds," and then I set the whole deck of cards aside and I said, "Well, now we know that deck is full of diamonds, nothing else," you would laugh me out of the courtroom and say, "Lanier, give me a break. You just showed us two of the cards."

What they're going to do is parade certain studies -- it's like parading certain pages of exhibits and leaving out other pages -- they're going to parade certain studies in front of you that all seem to show this to be a jack of diamonds drug.

THE COURT: You need to finish in about three minutes.

MR. LANIER: Okay, thank you, Judge.

And all I can say is just hold on and wait because it's my obligation and duty to show you the rest of the deck so that you know what all the cards are on the table, and that's what my job is, and that's what I'll do. So the final thing I have to say in the last two minutes is, when you analyze this, don't ever be persuaded that you're trying to look for the cause of the suicide. The question is, in the great wealth of the world, was this drug a significant contributing cause? Was it a significant contributing cause, not was it the cause? The cause is way too complicated.

So those are what I anticipate the trial is going to unfold, both the themes that the parties will have as well as how we're going to approach it. We're going to do it through witnesses. We'll try and do it as quickly as possible. We've got a number of lawyers working on the case, and we'll see how it all shakes out. But we appreciate very much your time and attention, and I look forward to getting to know you, indirectly, over the next couple of weeks.

Thank you, your Honor.

THE COURT: Thank you. Why don't we stand up and stretch. You need to set up.

MR. OHLEMEYER: Just for a minute, your Honor. Thank you.



MR. OHLEMEYER: May it please the Court, counsel --

THE COURT: Why don't we wait till everyone -- all set?

MR. OHLEMEYER: Thank you, your Honor.

THE COURT: I can barely see you surrounded by all those.

MR. OHLEMEYER: Snippets.

Ten years before Mrs. Bulger died and before she ever took Neurontin, she told her doctors that the disease had made her depressed, that she was always depressed because the disease had taken the life right out of her, a life that had been active but now was one where she just existed with no desire whatsoever, in which she was moody each and every day.

THE COURT: A little bit louder.

MR. OHLEMEYER: The evidence you're going to hear in this case, as Mr. Lanier said, is that suicide can be difficult to explain, and at other times it has a sense of inevitability about it, unfortunately. But it's never far from depression, pain, substance abuse, and the things that make a life difficult. And the evidence you'll hear in this case is that Mrs. Bulger had medical conditions that are known causes of suicide, that increased her risk of committing suicide, and actually caused her to attempt suicide before she ever took Neurontin. The Neurontin Mrs. Bulger was taking, you'll hear from the doctors, is actually one of the few things in her life that was not making it more difficult.

Now, I agree with Mr. Lanier that the life you're going to hear about is a tragic life, and it raises a question: What caused this woman to commit suicide? What caused Susan Bulger to commit suicide? The plaintiffs say it's Neurontin, and that's what they've alleged, and that's what they believe. But beliefs and allegations aren't evidence, and the evidence you're going to hear from the witnesses who testify will have to prove those beliefs, because at the end of the day, we're going to have to try to answer my question, what caused Mrs. Bulger's suicide?

Good morning again. My name is Bill Ohlemeyer, and with Charlie Goodell and Rick Barnes, we're going to present Pfizer's evidence to you. And you're going to hear about Pfizer and you're going to hear about Neurontin, but you're going to hear a lot about Mrs. Bulger because it's impossible to understand suicide without hearing the personal history of the victim. We're not going to present that evidence to you to judge Mrs. Bulger, we're not presenting that evidence to you to blame Mrs. Bulger, but it's impossible to understand how Mrs. Bulger died unless you understand how she lived, so we're going to present the story of her life to you so you can answer the questions that have to be answered in this case with confidence.

The evidence I'm going to present involves four major issues, and the first one will discuss the circumstances in Mrs. Bulger's life that may explain why people make this tragic choice and why specifically Mrs. Bulger may have made it. You're going to hear evidence about Neurontin and whether it or something else was a substantial factor, or whether anyone can determine what the substantial factor was in causing Mrs. Bulger's suicide. Mr. Lanier described a company that you might think sounds reckless, and we're going to present evidence about Pfizer so that you can answer the question, is Pfizer a reckless company? And we're going to tell you what the evidence is that connects Neurontin to suicide and what the data is when people actually try to do these tests and answer these questions.

So you're going to hear that Neurontin is an important medicine that actually helped people who weren't being helped by other medicines. You're going to hear how it was tested, how it was monitored, how it was labeled, and you're going to hear how Pfizer helps doctors help their patients.

I said it once and I'm going to say it again. Mostly you're going to hear about Mrs. Bulger because this is a case about Susan Bulger. The plaintiff in this case is the estate of Susan Bulger. It's not Regina Bulger. It's the estate of Susan Bulger. Mr. Lanier represents the estate. Mr. Egilman who you met is the administrator of the estate. And because it's a case about Mrs. Bulger, that's what I want to start talking about this morning.

Susan Bulger lived a life filled with pain beginning when she was about seventeen. The doctors that you'll hear testify will tell you that healthy people don't understand what it's like to live in constant pain; not just muscle aches and backaches and headaches, as difficult as that can be, but what doctors call neuropathic, which is pain in the nerves, or chronic pain, pain you can't treat with aspirin or Tylenol.

Mrs. Bulger's difficult life began when she was a child. You'll see medical records. And these are excerpts. They're not snippets. You'll see the whole record. These records are available to Mr. Lanier. He's actually seen these records before this morning.

Mrs. Bulger told her doctors she had a lousy childhood in which she was constantly physically abused. She ended up in a foster home. She was diagnosed with depression in the 1980s, and she suffered from it her entire life. Mrs. Bulger had substance abuse problems as you've heard, alcohol and cocaine, crack cocaine, and even heroin. And unfortunately she suffered from a degenerative, incurable autoimmune disease called rheumatoid arthritis, and she was diagnosed with rheumatoid arthritis when she was seventeen.

Rheumatoid arthritis is a disease that causes the body to slowly fall apart. By the time she was thirty-nine, Mrs. Bulger had more than a dozen surgeries, including two complete elbow replacements, a wrist fusion, and an amputation of one of her toes. Rheumatoid arthritis is the disease she was talking about when she told the doctors at Brigham and Women's in 1993 that she was always depressed because the disease had changed her life.

And sometimes you'll see handwritten medical records in this case. Sometimes it will be Mrs. Bulger's writing. Sometimes it will be doctors who are taking information down from her. And one of the challenges in this case and one of the difficulties in this case is, there's a lot of personal information we're going to have to present to you, and it's difficult but it's important to know it to understand the issues. And this information came from medical records. It comes from conversations Mrs. Bulger is having with her doctors, and we're going to share that information with you so you can understand what was going on in her life.

Mrs. Bulger also had serious and long-standing problems with her husband. She had an abusive and controlling husband. They had financial problems throughout their marriage. They even lost custody of their son for a while in the '90s. Mrs. Bulger also attempted to commit suicide several times, long before she ever started taking Neurontin. And you'll hear doctors, every doctor who testifies in the case will tell you that people who attempt to suicide are at a significantly greater risk of actually committing suicide in the future.

And Mrs. Bulger also had a variety of serious medical problems for which she was taking a variety of prescription drugs. In the last five years of her life, she took more than 30 different prescription drugs, including antidepressants, pain pills, and pills that were designed to help her with her anxiety disorder and some of her mood problems. You'll hear and you'll see testimony about Mrs. Bulger and these medicines.

At the time of her death, Mrs. Bulger had prescriptions for five prescription medicines. Including methadone, OxyContin, Effexor that she was taking in two different doses, Klonopin, and Neurontin. And the reason I said she was supposed to be taking some of these is because at the time of her death, the police asked Mr. Bulger to provide them with all of the prescription medicine that was in the house the night of her death. And based on records of her prescriptions, and you'll hear the doctors testify about this, there should have been 84 methadone tablets in a bottle in the home, but none were provided to the police. There should have been somewhere between 18 to 21 OxyContin tablets. None were provided. None appeared to be in the home.

This is important medicine. She's taking methadone for substance abuse and pain. She's taking OxyContin for her pain. The Effexor is an antidepressant that the doctors were giving her in two different dosages. Klonopin is an antianxiety drug, and Neurontin of course you've heard about. The Effexor, there should have been 12 of the 150-milligram pills. There were only six. And there should have been none of the 37.5-milligram pills, and there were six. So it appears that Mrs. Bulger was taking the methadone and OxyContin she was supposed to be taking and wasn't taking the Effexor, the antidepressant, as directed. Klonopin, there was nothing found, and nothing should have been found. If she took it as prescribed, she would have run out of the prescription on that day. And the Neurontin, there were 44 pills provided to the police that night. There should have been 24, which again tells you Mrs. Bulger was not taking Neurontin as directed. There was more medicine in the house than there should have been.

Now, Mrs. Bulger also had a history of not taking medicine as directed. You'll see and you'll hear more than a dozen different times in the medical records she tells her doctors that she stopped taking medicine on her own, antidepressants, pain pills, other anti-anxiety medicines, and even Neurontin a couple times. You'll hear about that in a minute. She told the doctors that she didn't like the way it made her feel, or she didn't like the side effects, or she didn't think they were working, and you'll hear testimony about this throughout the trial.

Let me tell you a little bit about the two doctors who actually prescribed Neurontin to Mrs. Bulger. These doctors treated Mrs. Bulger for nearly four years prior to her death. They were trying to help her manage a variety of medical conditions, including her pain. Dr. Crognale went to Salem State, got his M.D. at UMass, trained at Beverly Hospital, and he's an internist in family practice.

Dr. Goldman got a bachelor of science at Wesleyan, a master's in public health at UCLA, got his medical degree at BU, trained at Boston City, and also has a family practice. Unfortunately, Dr. Goldman died recently, so you'll hear his testimony through a videotape deposition. Dr. Crognale has moved to Africa where he's actually working in a village in Africa. He too will testify through a videotape deposition.

You'll hear these doctors tell you that they treat people with chronic pain, with neuropathic pain. And everybody's different, so they use a variety of prescription and over-the-counter medicines to treat their patients. But Neurontin is one of the medicines they use for people like Mrs. Bulger who had problems that weren't being successfully treated by other medicines.

Now, Neurontin is not something you can buy at the CVS without a prescription. Your doctor has to prescribe it to you. And to make a decision like that, these doctors had to decide that it was going to help Mrs. Bulger. They thought Neurontin made sense for Mrs. Bulger because it wouldn't interact with the other medicines she was taking, and it wasn't addictive, and she had a problem with substance abuse.

Now, you're going to hear that companies like Pfizer, and Pfizer in particular, are in business to provide doctors like these with tools they can use to help their patients. They do well by doing good. They're not perfect, and you're going to hear how they were called to account for the mistakes they made, but they do well by doing good. These doctors are trying to help Mrs. Bulger. They were well aware of her background, they were well aware of her medical conditions, they were well aware of her problems, but they thought Neurontin had the best chance of helping her, and the evidence you will hear is that it did.

Now, Mrs. Bulger's pain is described in a letter she wrote in her handwriting to a Dr. Jacobs in 2002, and she told Dr. Jacobs that she was diagnosed in 1982 with rheumatoid arthritis, and she hasn't had a day go by without experiencing pain, pain she describes as excruciating, and she told the doctor every day was a pain-filled challenge for her. This doctor was talking to Mrs. Bulger about prescription medicines, particularly narcotics, and he wanted her to make sure she understood the risks and the benefits of those medicines, and she told him in this letter, "There are drawbacks to pain medication such as addiction, tolerance, and damage to organs. That goes for arthritis medicine too. I have been on medicine that's made my bones brittle, my hair fall out, made me gain a bit of weight, put stress on my arthritis, and the side effects can affect my liver. But to me any medication, be it narcotics or arthritis medication, has adverse effects, but I need the medicine because of the pain." And you'll see and hear more testimony about this from Dr. Jacobs.

Not treating Mrs. Bulger's pain was not an option for Drs. Crognale and Dr. Goldman. Pain is important. It causes other problems. It actually can increase depression. So they had to do something for her. Other medicine that she was taking had side effects, it didn't work, or it was addictive. Fortunately for Mrs. Bulger the Neurontin that they prescribed to her for per pain worked, and you're going to see here why.

You'll see and you'll hear from doctors that Mrs. Bulger had been treated with a variety of different medications to treat her pain, none of them effectively. In 1996 her doctors noted that she was overusing Percocet because it was the only way she could get pain relief. Again, it's an addictive narcotic. You don't want your patients overusing it, especially if there are other alternatives.

So in 1999 an arthritis specialist noted that Mrs. Bulger had tried numerous disease-modifying antirheumatic drugs, but that either had bad side effects or they didn't work, lack of efficacy. "Efficacy" is the word you'll hear a couple times. It means they didn't work. Methotrexate caused her hair to fall out. That's what alopecia is. Imuran didn't help, and gold shots helped her once but not again.

Then she sees Dr. Jacobs, as we just said, and in that same letter she tells him, "The arthritis medicine I was put on, such as gold shots, methotrexate, Imuran, took weeks to work, and if and when they finally did, didn't seem to last long or protect my joints. Therefore I've had all these operations."

She sees Dr. Goldman in 2003, and he notes that she's been on everything for her pain; nothing has had any long-term effect, but the Neurontin was helping her significantly with both her affective disorder, with her moods, and her pain.

These doctors prescribed Neurontin to Mrs. Bulger because it made sense to them, and they'll tell you that Neurontin doesn't have many side effects. It's not metabolized by the liver. It basically leaves your body unchanged. It doesn't have toxicity risks. It doesn't interact with other medicines you're taking. You can't really overdose on it. And Mr. Lanier's joke was based in science in a sense. You can't overdose on Neurontin, which is important for a woman who's had a prior suicide attempt by overdose, and you'll hear about that. It has a speedy half-life of five to seven hours, which means that it doesn't stay in your body very long. You can take multiple doses. It's not addictive, and it's a good option for patients who are refractive. And the doctors you'll hear testify will tell you that refractive means nothing is working for them. So Neurontin, when you think about Mrs. Bulger with a history of substance abuse, some possible addiction problems, and prior suicide attempts, was the choice that these doctors made.

Now, the reason they made this choice is not because of something a salesman told them. You heard a lot of discussion from Mr. Lanier about evidence that he expects to present about Pfizer and Warner-Lambert and doctors. The two doctors who testify about Mrs. Bulger are going to tell you that they made this decision based on their background, their education, their experience, what they knew about Neurontin because they'd used it with other patients, what they'd heard about it from other doctors, but not because of anything that Pfizer told them or Warner-Lambert told them. They will tell you that they were never at the Chateau Elan in Atlanta, they were never involved in any of these things you've heard talked about. They prescribed Neurontin to Mrs. Bulger because they were trying to help her and they thought it would work, and the undisputed evidence is that it did help her.

You'll see and you'll hear about all the references in the medical records to Neurontin. This is the time line. This is every reference to Neurontin in Mrs. Bulger's medical records. Dr. Crognale was not the first doctor to prescribe it to her. Another doctor prescribed it to her in 1999. She took it for about six weeks, stopped taking it without telling that doctor. In October then she starts to see Dr. Crognale, and in that time period from January to October, her medical conditions got worse. But she told Dr. Crognale the first time she saw him, "I used to take Neurontin, but I stopped because it made me feel out of it."

She sees Dr. Crognale from January of 2000 to May of 2002, and you're going to see some of those records, and her medical conditions don't get any better. They continue to get worse. He puts her back on Neurontin in 2002, May of 2002. She never says to him, "I don't want to take it." She never says, "It made me feel depressed, it made me feel suicidal." She told him that "Way back when I stopped taking it once because it made me feel out of it."

By August of 2002, the records that Dr. Crognale is taking of each visit with Mrs. Bulger report that he's getting good results with Neurontin for sleep. It's helping her sleep, helping her pain so she can sleep better. By November of 2002, Mrs. Bulger stops taking it again without telling Dr. Crognale; and she later tells him, well, she sees him a month later, she says, "It made me feel moody."

Now, the evidence in this case will be, there's nothing unusual about a patient with the kind of medical problems Mrs. Bulger suffered from feeling moody. In fact, you'll remember when she talked to the doctors at Brigham and Women's in 1993, she told them, "I'm usually very moody most days because of the arthritis."

Dr. Crognale puts her right back on Neurontin in December of 2002 and increases her dose to 1,800 milligrams a day. So she's taking three pills in the morning, three pills at night, and she does it for about a year at that dose. That's a higher dose than she was taking at the time of her death, or was supposed to be taking at the time of her death.

In April of 2003 Dr. Crognale continues to see Mrs. Bulger. He specifically notes she's not thinking about suicide. This is while she's on Neurontin at a higher dose. By May of 2003, Mrs. Bulger is complaining to Dr. Crognale that her insurance company isn't paying for her Neurontin. Now, she's never, once again, said it made her feel out of it, never once again said it made her feel moody, never said it made her feel depressed, never said it made her feel suicidal; and in fact she's complaining because she's not getting it as quickly and as cheaply as she'd like to get it.

He also points out in that same visit that it's helping her with her mood stability, she's less depressed, she's less anxious because in combination with another medicine called Lexapro, she's feeling more even, and she's having no side effects. Neurontin is helping her sleep better. Unlike Klonopin -- remember, Klonopin was one of the medicines she had a prescription for on the day of her death, which she'd been taking but thought worsened her depression.

By September of 2003 Mrs. Bulger starts to see Dr. Goldman. He continues to prescribe Neurontin for her pain. She sees him nearly every month in the year before she dies. In January 2004 she asks him to fill out some paperwork to get something called Prescription Advantage. Again, it's a way for her to get Neurontin at a reduced cost, which Dr. Goldman says took a load off her mind and a load off her wallet.

By April of 2004, Dr. Goldman notes that the pain medication is not working as well as it used to because she's developing tolerance to the antidepressant and the methadone. The entire time that Mrs. Bulger was taking Neurontin after Dr. Crognale prescribed it to her in May of 2002, with one exception, she never stopped taking it, never complained about taking it, never said, "I don't like the way it makes me feel," never said, "It makes me feel depressed," never said, "It makes me feel suicidal."

And these doctors were paying attention to those kinds of things. They were talking to her about depression and about suicide at nearly every visit. They were keeping track of her medicines, and they were asking her how her medicines made her feel.

Dr. Goldman in March of 2004 points out that Mrs. Bulger is doing pretty well, but she ran out of her Effexor and she started to feel lousy. Effexor is the antidepressant that he told her not to stop taking under any circumstances, and, again, on the day of her death, it doesn't appear she was taking it as directed. These doctors knew what to look for, they knew what to talk about with their patients, and they kept track of Mrs. Bulger because they were trying to help her.

Now let me turn to a more difficult subject in a way, and that's suicide itself. There are 30,000 suicides in this country last year. It's about 84 every day, which means three times an hour somebody makes that choice. And people have studied it. The American Psychiatric Association, the National Institute of Mental Health have determined that there are known causes of suicide. people who have depression, people who have anxiety disorders, people who have pain are at increased risks for suicide. It's not because of my medicines they're taking. It's because of their underlying medical conditions. Those are the same kinds of people, though, who have to take medicine to try to treat those conditions.

There are other risk factors for suicide that you'll hear about, and they are things that people have studied and published, and the doctors who will testify will tell you about that. And you'll hear that some people, you know, that some people have many risk factors for suicide but don't commit suicide, and other people have very few or no apparent risk factors and actually commit suicide. It's very difficult to know why, but what the doctors who testify will tell you is, 20 to 40 percent of the people who commit suicide don't even have depression or anxiety disorder. Their substance abuse and their pain is enough of an explanation.

You're going to hear testimony and you're going to hear evidence that Neurontin has been prescribed to millions of people since 1993. Nearly 14 million people have taken it, and in that time the suicide rate in the United States has not gone up; it's actually gone down. There have been hundreds and thousands of studies published and you're going to see and hear about them where people have actually looked at the questions Mr. Lanier raised, and the evidence you're going to see, and I'm going to show you some of it in just a few minutes, is going to show that Neurontin doesn't cause people to commit suicide, it doesn't contribute to their suicides.

The one thing we do know about Mrs. Bulger, though, is, before she ever took Neurontin, she was at an increased risk of suicide. She had medical conditions that are causes and known causes of suicide, and she had tried to commit suicide.

The American Psychiatric Association has published a guidebook for doctors, Practice Guidelines for Assessment and Treatment of Patients With Suicide Ideation. And you're going to hear a witness from Harvard, a witness from McLean, local doctors who will tell you that they treat people with these problems, they do research in this area. You're even going to hear from one of the doctors who was involved in preparing this book for other doctors, and they will tell you that the most significant risk factors for suicide are anxiety disorders and depression, things like post-traumatic stress disorder. Physical illness including chronic pain is a risk factor for suicide. Psychosocial problems, Mr. Lanier mentioned some of them; the lack of social support, an unstable domestic situation, unemployment, stressful life events, financial problems. Childhood traumas, whether it's sexual or physical abuse, can be an increased risk for suicide. And, of course, as I said, people who think about and actually try to commit suicide are at a significantly greater increased risk of actually committing suicide. And, unfortunately, when you see and hear the evidence in this case, Mrs. Bulger's life never got very far from that list, and let me show you in some time sequence how some of these problems showed up in her life. Mrs. Bulger was diagnosed with depression in 1986, and every doctor you'll hear from and every medical record you'll see was that depression was a constant theme throughout Mrs. Bulger's life. She told Dr. Crognale the first time she saw him that she was significantly depressed, that she'd had severe depression in the past, and she was feeling that way at that visit. Now, this is nearly a year after she had stopped taking Neurontin. It's four years before her suicide. She talks about the stress she has at home, both financial and otherwise. And you're going to hear unfortunately that parenting was an issue for Mrs. Bulger, in part because of her physical problems. She talked to her doctors frequently about her doubts about her ability to be a parent with some of the physical and psychological problems she had.

She told him that a doctor told her she might be bipolar. There's going to be a little bit of testimony about that, but there's really no doctor who's going to say that Mrs. Bulger was actually suffering from that. She tells her doctors that she was experiencing depression her entire life. She tells Dr. Crognale that medicine like Prozac isn't helping her depression. She has a long history of abuse, and he and she agree she has post-traumatic stress disorder related to that. He encouraged Mrs. Bulger to seek counseling. You know, and she did seek counseling for a while right after the birth of her daughter, and unfortunately when her daughter was born, her daughter had to be detoxed. Mrs. Bulger was using illicit during her pregnancy and --

MR. LANIER: Objection, your Honor. It wasn't illicit drugs. It was methadone she was on. THE COURT: Overruled. You'll hear the evidence. Remember, this isn't a substitute for the evidence.

MR. OHLEMEYER: Thank you, your Honor.

You're going to hear that Mrs. Bulger was encouraged to and actually did start going to counseling and therapy after the birth of her daughter. That lasted until August of 2003. And as part of that therapy, she had to get urine tests and she had to keep the therapy treatments, and you'll see some of those records. Unfortunately she stopped doing that in August of 2003, the year before she died, and that might have contributed to some of the problems that led to her death, but she did seek counseling and she was being counseled during the time she saw Dr. Crognale.

Dr. Crognale was talking with her about depression and pointed out to her that if she had increasing signs of depression, she should talk to him about that. The counseling records, the Center For Addictive Behaviors where she was getting her counseling and therapy, discuss the post-traumatic stress disorder, the anxiety, and her problems with Mr. Bulger, all of which you'll see and you'll hear about when the doctors come testify.

Pain was something we already talked about, and Mrs. Bulger obviously had a significant amount of pain, and she had a dozen surgeries before she died. So depression and pain were always a part of Mrs. Bulger's life, even before she ever started taking Neurontin. Dr. Goldman sees her in December of 2003 and points out that even though she's doing okay, she's never without pain.

Now, there are other issues that you'll hear about that contribute to an increased risk of suicide, including what are called psychosocial features. And you'll see and you'll hear testimony about the Bulgers' marriage. You'll see and hear testimony about their financial problems; they have a couple of bankruptcies. But most importantly you'll see and you'll hear testimony that Mrs. Bulger unfortunately didn't have a lot of friends. She was very isolated. She didn't have the kind of support system that people who are at risk for committing suicide need as a protective factor to help prevent these things from happening.

You've seen Mrs. Bulger's reference already to her childhood. The doctors who will testify about suicide will tell you that childhood abuse and childhood trauma is enough in and of itself to cause somebody to think about and commit suicide later in life. It's unfortunately one of the most difficult and hard things to overcome for people.

Substance abuse Mr. Lanier talked about and you'll hear about. Again, it's one of the unfortunate things that cause or contribute to cause suicide in people, and Mrs. Bulger had a long history of substance abuse, again, before she ever started taking Neurontin, which put her at risk for suicide.

And you'll see and you'll hear that Mrs. Bulger attempted to commit suicide multiple times, again, before she ever took Neurontin. Remember, Mrs. Bulger only took Neurontin from May of 2002 to 2004. She took it for a few months back in 1999 right at the end of the year; but all of these problems, these known causes of suicide, these medical conditions that increase your risk of committing suicide, that caused her to attempt to commit suicide, occurred before she ever started taking Neurontin.

Mrs. Bulger's first suicide attempt occurred in 1978. She cut her wrists when she was fourteen. It followed some problems she had at home with her mother. In 1982, she drove a car off a cliff with the intent to hurt herself. And you'll see a pattern in these attempts. They almost always follow a domestic disturbance and a substance abuse problem, overuse of substances or being high and out of control, as her sister testifies.

In September of 1989, she goes to the emergency room and tells them, "I'm afraid I'm going to try to hurt myself." In 1990 she overdoses on Valium and cocaine and cuts her wrists and has to be taken to the hospital. In 1993 Mrs. Bulger was in a coma for four days because she overdosed on an antidepressant drug called Elavil following a dispute with her husband and an effort to stop taking it. She was not taking it on her own. She became more depressed and overdosed and nearly died. The doctors will testify that Mrs. Bulger was very fortunate to have survived four days in a coma. There's another episode of cutting her wrists in February of 1998, and then, unfortunately, as we know, Mrs. Bulger committed suicide in September of 2004.

Now, there's no way to know for sure that Mrs. Bulger took Neurontin on the day she died. You'll hear testimony about this, but there was no eyewitness who actually saw her take it. There was no autopsy conducted, there was no blood test done, and there's evidence that she wasn't taking Neurontin as directed. But if -- if you want to assume she did take Neurontin the day she died, you have to assume she took it the day before, the week before, the month before, and for two years without it causing any problems for her. She took Neurontin for nearly 600 days, which is more than 2,300 tablets, without ever complaining about it, without ever not taking it, without ever telling her doctors it was making her depressed or suicidal, which are subjects she was talking about with them all the time. Now, evidence comes in a lot of different forms.

You know, in a DWI case, you have a blood alcohol test. In an asbestos case, you can look at an X ray to see the damage that asbestos does to people's lungs. In this case, you're not you're not going to see any evidence that says this has to have been a suicide caused by Neurontin. There's no signature or distinctive issue that shows us that this was caused by Neurontin.

The evidence you're going to see and you're going to hear is that Mrs. Bulger was taking Neurontin for nearly two years before she died at a higher dose for a period of that time than she was supposed to be taking at her death. She never claimed it made her feel depressed, and her doctors believed that it was helping her. They never said in those medical records it isn't helping her.

At the same time Mrs. Bulger has other issues in her life that have put her at risk for suicide before she ever takes Neurontin. And pain increases somebody's risk of suicide two to five times over the general population's risk. Substance abuse increase it fourteen to twenty times.

If you have major depression, you are twenty-one times more likely to commit suicide than people who don't have that. Now, as we know, Mrs. Bulger committed suicide on August 4, 2004, and why she chose that moment to do that is something that nobody is going to be able to answer for you in this lawsuit. The best we can do is look at the events that led up to it to try to see what was going on in her life at that time. And we know that prior to August, 2004, Mrs. Bulger had depression, pain, psychosocial problems, childhood trauma, substance abuse, and prior suicide attempts. They were preexisting risk factors for suicide.

At the same time, in the weeks and months leading up to her death, you're going to hear evidence and testimony that she really was isolated from her friends and family. In fact she and her sister were making some plans for her to leave Mr. Bulger that he got in the way of and prevented from happening. They had a recent bankruptcy.

Mrs. Bulger was facing her fourteenth operation, and it was one she knew was not going to solve her problems or end her pain. She was having a bad flare-up of her arthritis. Two days before her death she called her doctor and says, "I'm out of methadone," which he thought was odd because she should have had more, "and I'm having a bad flare-up of arthritis. I need something for my pain." She actually filled a prescription the day she died for prescription-strength ibuprofen. She was out of methadone. She was missing prescriptions. She might have been in withdrawal because she wasn't taking the methadone, and you're going to hear some disturbing testimony from a neighbor of Mr. Bulger's that Mrs. Bulger might have been actually abusing crack cocaine in the days and weeks leading up to her death. You'll also hear that same kind of testimony from her sister.

So there are a lot of things, unfortunately, going on in Mrs. Bulger's life in August of 2004 that are better explanations for what happened than the Neurontin that she might have been taking, the Neurontin that she was taking that there is no evidence, and there will be no evidence, was making any of these problems that she had any worse, and in fact the evidence will be that it was actually helping her.

All right, let me shift gears for a minute now and talk about Pfizer and Neurontin. As Mr. Lanier told you, Pfizer didn't invent Neurontin. It wasn't the first company to manufacture Neurontin. It was developed by a company called Warner-Lambert. Pfizer merged with Warner-Lambert, and Neurontin then became a Pfizer product.

Neurontin was approved by the FDA, as Mr. Lanier told you, to treat epileptic seizures. It's an antiepileptic drug. It was also approved again in 2002 to treat postherpetic neuralgia, the pain associated with postherpetic neuralgia. And you're going to see and hear that the development of Neurontin began a long time before that. The development of a medicine like Neurontin begins with a scientist who discovers something in the laboratory that he or she thinks is going to help improve human health. It's a compound at that point. And then it goes through preclinical testing, usually with animals, and that took seven years. Then you go into clinical trials, which are studies in people, and you're going to hear a lot more about that than the evidence Mr. Lanier talked with you about. And then, finally, the FDA reviews that information and approves the drug for specific uses.

You're going to hear that Dr. McCormack, the Dr. McCormack who was involved at the FDA, who was involved in some of those things Mr. Lanier showed you where there were some questions about depression and suicide in those clinical trials, looked at the information, and a year and a half later reported that, no, there is no evidence to suggest that those problems were caused by the medicine. And that's because the people who were in these trials and the people who take these medicines have medical problems that in and of themselves cause those kinds of problems. There's a background rate of these kinds of medical problems in the population of people who take Neurontin.

So the reason the FDA requires you to submit these trials, these tests, is to demonstrate that the medicine does what it's supposed to do but doesn't cause any unnecessary risk to the people who are taking it. And the way you do that and the way the FDA requires you to do that is to do a controlled study, a randomized placebo-controlled clinical trial. It's a long way of saying that you measure it instead of looking at it. Just because somebody who takes Neurontin or any other medicine has a problem doesn't mean that problem was caused by the medicine. It might be something else, or it might be something that they're taking the medicine for that is producing the problem. So you do a study like this: You take a group of people who are identical in every way. You divide them into two groups randomly. You give one group the medicine; you give one group something called a placebo, a sugar pill. Nobody knows what they're taking. You give them the medicine, you keep track of them, and you record how they react, positive and negative. And then at the end of it all, you do some statistical analysis to make sure what you are seeing is not a coincidence or is not what you expect to find in that group of people but is actually a difference caused by the medicine.

Those kinds of studies were done, and you're going to see and you're going to hear a lot of testimony and a lot of evidence about them. They're the most reliable and scientific way to answer the question this lawsuit raises, which is, can Neurontin cause suicide in anyone, before we even start asking the question, what about Mrs. Bulger?

These kinds of studies were conducted, and they were submitted to the FDA multiple times. They were reviewed by the FDA. All of the information you're going to see comes from Pfizer or Warner-Lambert and was given to the FDA, and it was analyzed for a variety of different reasons. And never before Mrs. Bulger's death did anyone look at that information and say, there should be more information in this label that is given to doctors that tells them about suicide and suicidal thinking, because there was no evidence to suggest there was.

When you go back and look at that data from the controlled clinical trials for suicide and suicide attempts, the evidence you'll see is that there was nobody in those clinical trials, those controlled studies, who committed suicide or attempted to commit suicide. In fact, suicidal ideation, which is thinking about suicide, the people on the medicine, on Neurontin, were essentially no different than the people on the placebo. There were two out of 5,200 versus one out of 2,600. You see that statistically it's about the same. So when you do the controlled study, you don't see people thinking about suicide more often who are taking Neurontin than people who are taking the placebo. They looked a little closer at the issue of depression. When you look at depression -- and this was something that was submitted to the FDA and that the FDA looked at back in 1992, and this is where Dr. McCormack, who said before we should be careful about this, looked at it, looked at the data, and then said later, "There's no evidence here to suggest people who take this drug are more depressed than we would expect them to be." 1.8 is more than 1.1, but you'll hear that's a statistical tie, that essentially that's no difference.

They looked a little harder at what are called psychobiologic events. These are events like hostility, anger, you know, things that change your behavior. And, again, when you look in the epilepsy trials, people who have medical problems who are being given Neurontin, that the placebo patients actually had a higher incidence of adverse psychobiologic events than the Neurontin patients.

In the postherpetic neuralgia application that Mr. Lanier told you about, and these are the patients who are closer to people like Mrs. Bulger, you'll see that the placebo patients again had essentially the same or a little bit higher incidence of depression than people on the pill, which again tells you that the medicine is not causing new or additional problems in the people who are taking it.

Now, the FDA reviews all of this, and this label that Mr. Lanier showed you and talked about is the label that goes to doctors. It's the information the doctors get. The FDA reviews this. They tell the company where to put these results and how to describe them. And nowhere in this label before 2004, before Mrs. Bulger died, did the FDA tell Pfizer or anyone else that you have to tell people that Neurontin causes suicide or suicidal thinking because the evidence didn't suggest it did.

Now, Mr. Lanier also talked to you about this challenge-rechallenge kind of test where you give somebody the medicine, and you take it away, and you give it back. You'll see and you'll hear that the people who were on placebo had the same kind of phenomenon. You could see the same kind of results when you give somebody the placebo. They say, "Oh, I think it's making me feel more depressed." You take the placebo away, they feel better; you give them the placebo back, it makes them feel worse.

So there's going to be a lot of evidence about scientific data, and the two things I think are important to remember is that there are controlled studies that measure things. We compare two groups of people in a controlled setting to see whether there's really a difference. And then there are observations, things that we observe in people. And the fact that you observe something in someone doesn't mean it's a cause of what you're observing. There might be other explanations, or there might be more information that needs to be reviewed.

Now, the idea that you are going to use an antiepileptic drug to treat pain is not something that Pfizer thought up on its own. Doctors have been using antiepileptic drugs to treat pain since the 1960s. It was reported in the medical literature for a variety of reasons. It seemed to help people with pain. That kind of prescription, as Mr. Lanier told you, is called an off-label use of a medicine. It is not illegal to prescribe medicine off-label. There are strict rules, though, about how you can promote medicine off-label, and you're going to hear about the violation of those rules.

Off-label medicine is allowed because the FDA doesn't regulate the practice of medicine. They want doctors to be free to use their judgment to help their patients. The FDA has said that off-label prescriptions are accepted, rational, and of great value. They're not illegal. But there are rules, again, about how you can promote medicines for off-label.

Off-label helps patients who aren't being helped by other medicines. It gives doctors the ability to treat people with medicine and to take advantage of medical developments that occur faster than the FDA process.

It's very common. Using oral contraceptives to treat acne is an off-label use of a medicine. Using blood pressure medicine to treat migraines is an off-label use of medicine. In fact the majority of prescriptions for antiepileptic drugs are off-label prescriptions for the most part to treat pain.

Now, as Mr. Lanier pointed out, there are rules about how you can promote off-label use, and Warner-Lambert violated those rules. And it's a strict liability violation. Even if what you tell the doctor is absolutely true, you're not allowed to do it, and they were held to account for it. They paid a fine for it. But there was no charge that they'd said anything false or misleading. There was no claim of fraud. It was a violation of the rules. It was a serious violation. They paid a serious fine.

None of that has anything to do with Mrs. Bulger. It occurred before Mrs. Bulger ever took Neurontin. It occurred before Warner-Lambert and Pfizer merged. It occurred in 1995 and 1996 in a limited part of the country, and the doctors who prescribed Neurontin to Mrs. Bulger, Dr. Goldman and Dr. Crognale, will tell you that they prescribed Neurontin to Mrs. Bulger because of their judgment, not because of something anyone from Pfizer or Warner-Lambert told them. In fact, they had a hard time remembering specifically ever seeing anyone from Pfizer or Warner-Lambert, and they specifically said they had no recollection of anyone trying to promote Neurontin to them for off-label uses.

Neurontin was tested in controlled studies in people who were part of a vulnerable population, people who had medical problems that put them at risk for other problems. The fact that Mrs. Bulger took Neurontin while she had other problems or at the time she committed suicide doesn't prove it was a substantial factor in causing her disease. You have to look at controlled data. People who studied this look at controlled data, and the data didn't prove that Neurontin had anything to do with those problems.

So without data, without results from these tests, you're going to hear testimony from some witnesses that Mr. Lanier is going to call about a theory that somehow Neurontin might increase depression and therefore contribute to suicide. You're going to hear that that's a theory, that it's contradicted by what scientists and other doctors have read and written about and researched, but it really doesn't answer the question that has to be answered here. And in fact you're going to see and you're going to hear testimony that when you do a controlled study to see what happens when people take Neurontin, that it does not increase the chemicals in the brain that those doctors will tell you contribute to depression and contribute to suicide.

So the last thing we're left with are statistics, and Mr. Lanier told you about the FDA's recent statistical analysis of antiepileptic drugs. And what the FDA did is, they asked the manufacturers of eleven different antiepileptic drugs to "Send us your controlled data, send us your clinical trials. We're going to analyze this because we're concerned that this medicine might have something to do with people thinking about suicide."

Now, when they looked at that data, they saw some things that have to be considered if you're going to answer the question, what does this have to do with Mrs. Bulger? The first thing that you have to understand is that Neurontin, gabapentin, is a different chemical than the other ten drugs that were looked at. They're all different drugs. They're made differently. They do different things in the brain. They have different chemical structures. They're different chemical compounds.

Well, why is that important? Because when you look at the data from each of those eleven drugs, they don't behave the same way. Remember I showed you earlier the controlled clinical trial data from Neurontin as it related to suicide and suicidal thinking, and there was really no difference between the Neurontin and the placebo when those tests were conducted. When you look at those other eleven drugs, you'll see that two drugs, lamotrigine and Topiramate, actually accounted for a large number of cases of suicidal thinking. If you study the other drugs by themselves, you don't see the same kinds of results. The Neurontin data is different than the lamotrigine data. It's different than the Topiramate today. The FDA, though, says -- and this is what the FDA does, and you're going to hear there's nothing wrong with this, but it's different than the question we have to answer -- the FDA says, "We're going to treat all eleven drugs the same. In fact, we're going to treat all antiepileptic drugs the same, whether they were in the study or not." So if you make an antiepileptic drug, you have to put this label on it, and the label is: It might cause someone to think about suicide who wouldn't otherwise have done it. In fact, the statistics are that one out of 530 people might have had a suicidal thought who wouldn't otherwise have had one if they'd taken an antiepileptic drug. That means 99 percent of the people won't, but it doesn't change the fact that the Neurontin data is inconsistent with that.

If the question you have to answer is, from a public policy or public health perspective, should antiepileptic drugs all have the same label and should they say you might have an extra suicidal thought, it's a different question than did Neurontin have anything to do with Mrs. Bulger's suicide?

The evidence you're going to hear about Pfizer and the evidence you're going to hear about Neurontin is going to prove at least this much, and you're going to hear more and it will prove more: Neurontin really helps people with pain. It was studied for years in thousands of patients. There's no scientific evidence -- I shouldn't say scientific. There's no controlled studies, there's no reliable evidence that shows it causes suicide or makes depression worse. I mean, the observations you're going to hear about and the challenge-rechallenge, that's scientific. It's just not controlled, and there's a difference. That's an observation, not a measurement.

Neurontin has always had FDA-approved language on suicide and depression. The FDA has reviewed those labels. They've asked the company to make minor changes in them, and it wasn't until just recently that they said, "Make this change that we're making in all antiepileptic drugs." And even today after years of use with millions of patients and close scrutiny, even the FDA statistical analysis doesn't say antiepileptic drugs cause suicide. It says it may cause suicidal thinking in a small number of people, again, all based on data from two drugs, not eleven different drugs.

So let me summarize and thank you for your time and attention. I know it's warm up here. This is going to be a difficult case, in that we're all going to learn more over the next three weeks about suicide, I think, than we probably want to know. And the reason we're going to do it, again, is because we're trying to answer the question of what caused Susan Bulger to make this decision, and the evidence you're going to see and the evidence you're going to hear is that she had risk factors for suicide. We know that because she tried to commit suicide before she ever took Neurontin.

If she had never taken Neurontin but committed suicide, doctors will tell you that they could explain this to the best of their ability as doctors. And, of course, they will also tell you that you don't need Neurontin to make sense of what happened to Mrs. Bulger. Neurontin actually might have been helping Mrs. Bulger, and it probably was helping her because there was never a reference to suggest it wasn't.

Mrs. Bulger had a short, difficult life, and it was full of a lot of difficult, challenging circumstances that alone or in combination you'll hear are explanations for what happened to her. There's going to be evidence to answer the questions that are raised by this lawsuit, and the answer to that question is going to be that Neurontin was not a substantial factor in causing Mrs. Bulger's suicide. Thank you.

Thank you, your Honor.

  View Printable Version

Groklaw © Copyright 2003-2013 Pamela Jones.
All trademarks and copyrights on this page are owned by their respective owners.
Comments are owned by the individual posters.

PJ's articles are licensed under a Creative Commons License. ( Details )