Notes
Introduction: A Quintessentially American Company
Chapter 1: An Emotional Bond
Chapter 2: Three Brothers Go to New Brunswick, 1860–1968
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Notes – Page 360
Chapter 3: Mineral Twins
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Chapter 5: Birth of the Modern FDA
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Chapter 6: The Power of Pressure
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Chapter 7: A Meeting at a Harvard Hospital
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Chapter 8: Secrecy Is a Top Priority
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Chapter 1: A Sacred Cow
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Hemstock: However, they have a so-called expert on talc here who took an affidavit to the effect that it was true.
Placitella: And if that expert was never supplied with any of the testing that you actually did or you had people do for you, what would you think about that?
Hemstock: Well, I would be pretty skeptical of it for sure at the very least, yes.
Placitella: This expert Ashton, he never called you to ask you about anything, did he?
Hemstock: Nor do I know who he is.
Placitella: Right, and if he called you and said was there asbestos in the Emtal talc, you would have told him what?
Hemstock: I would have told him, as I always said, there are traces to be sure of asbestiform minerals in our talc.
Placitella: So as it’s stated here by the lawyers for Engelhard, asking for people to dismiss their lawsuits, that Engelhard’s talc did not contain asbestos, is that a true or a false statement?
Hemstock: On the face of it, it’s a false statement.
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Note: 372
Plaintiffs’ Attorney: Okay. And then there’s a line that says PR from the leaders. And then below that it says can we shut down the program; not adequately monitored and controlled; is it legal; coercion, threats, blackmail, question mark. Do you see that?
Montandon: Yes, I do.
Q: What was the reference to shutting down the program referring to?
A: I do not recall.
Q: And do you recall what your note about coercion, threats and blackmail is referring to?
Defense Attorney: Object to form.
A: No, I do not.
Q: What about your note that, is it legal, question mark, what does that note refer to?
A: I don’t recall the context of this note.
Q: Was J&J considering trying to use coercion, threats or blackmail to shut down the FDA program?
Defense Attorney: Object to form.
A: Absolutely not.
Q: Then why on earth would you write coercion, threats and blackmail in your personal notes?
Defense Attorney: Objection, argumentative, form.
A: I don’t recall the context of this exact section of these notes, but I know, having been at J&J for 27 years, in no instance has anyone ever talked about or mentioned coercion, threats or blackmail as an action the company would ever take.
Q: So was J&J thinking that they were the victim of coercion, threats or blackmail from the FDA?
Defense Attorney: Objection, asked and answered. The witness has testified extensively about this set of notes.
A: I do not recall the—the context of this note.
Q: Was it common for you to take notes about coercion, threats and blackmail in your work at J&J?
Defense Attorney: Object to form, argumentative.
A: No, it is not common.
Q: But you don’t recall the situation here with these notes saying coercion, threats and blackmail, right?
Defense Attorney: Object to form, asked and answered many times.
A: I do not recall.
Note: 373
Chapter 10: An Infamous Crime, the Birth of a Myth
Chapter 11: Problems with the Narrative
Note: 374
Chapter 12: Never an Adversarial Relationship
Notes : 375
Chapter 13: The Cost of Doing Business
Notes : 376
Chapter 14: A Valley of Death in Drug Discovery
Note:377
Chapter 15: The First Great Biotech Franchise Is Born
Notes: 378
Chapter 16: How Giving Cash to Doctors Became Good Business
Notes: 379
Notes: 380
Chapter 17: J & J’s Biggest-Selling Drug
Notes: 381
STUPAK: Anywhere in your advertising, did you say that use of Procrit for cancer patients who had tumors that Procrit would likely enlarge those tumors and endanger the lives of those patients?
TAYLOR: No, that was not a specific warning in the ads.
Q: But the FDA told you about that, and you didn’t put it in there. Don’t you think people should know that before they take your drug, that, in fact, it could worsen their condition, not make it better, by making tumors swell more and shorten their lifespan?
A: That is a theoretical concern that has been raised.
Q: Well, it has been documented, right? That tumors would swell with your stuff, the greater the Procrit they got, the quicker the tumors swell.
A: I don’t believe that that is accurate, but what we did do with the ads is we included all of the side effects that were significantly different from placebo.
Q: That would be significantly different, wouldn’t it, if you were a cancer patient and the tumors you had in your body swell when you took Procrit? Wouldn’t that be significant, especially when it shortens your life?
A: These are significant results as measured in clinical studies, so the side effects that were there, such as diarrhea and edema, were those that were significantly different from placebo.
Q: Can you point to any of the documents you submitted, anywhere, where the FDA approved Procrit for off-label use for fatigue or weakness in patients? Can you point to any one document you submitted to our committee?
A: Procrit has been approved for chemotherapy-induced anemia. Our advertisements were specifically looking at using language that would be recognizable by a consumer such as—
Q: So I take it your answer is no because you cannot point to an exhibit, as FDA wrote to you… telling you not to be using your ads for tiredness, for weakness. There isn’t a letter from FDA that said you can advertise for that.
A: In fact, all the way through, there have been discussions with the FDA about—
Q: I didn’t ask about discussion. I asked about approval for the way you marketed Procrit for seven years for an off-label use that was not approved for Procrit. Do you have any document that can show me that?
A: We have consistently, throughout, had reassurances that the way we were communicating the symptoms of anemia, such as fatigue and weakness, was appropriate to the patient group we were reaching with the DTC.
Chapter 18: A Brave Researcher Breaks the Silence
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Notes: 383
Chapter 19: Miracle-Gro for Cancer
Notes:384
Chapter 20: A Path to a Normal Life
Chapter 21: A Treatment for Everything and Everyone
Notes: 385
Here is plaintiff’s attorney Tom Kline discussing the strategy with Carmen Deloria, one of Johnson & Johnson’s top marketing executives.
KLINE: And another thing that we know for sure, like, for sure, is that you can’t sell on symptoms, correct?
DELORIA: You have to also give what the indication is so you can go within in the context of what’s in the label.
KLINE: You can’t sell on symptoms alone, can we agree?
DELORIA: Correct. . . .
KLINE: Do you see the key strategies?
DELORIA: Yes.
KLINE: The key strategy is, “Sell on symptoms, not diagnosis.”
DELORIA: Correct.
KLINE: That’s wrong before the autism label, correct? It’s just wrong. You can’t do it. Can we agree?
DELORIA: You have to provide the indication.
KLINE: I didn’t ask for that. I asked you is it wrong what it says right here, to sell on symptoms, not diagnosis. That’s wrong before the autism label change. Correct? Yes or no? Yes or no?
DELORIA: I would say no.
KLINE: Want another chance at it? And it’s wrong after the autism label by the very thing you just told us, correct? Yes or no?
DELORIA: It says diagnosis, not indication.
J & J LAWYER: Objection, your Honor.
KLINE: Sir, I’ll withdraw it and I’ll apologize for saying it. Is it correct, yes or no? Let’s start again. It’s wrong, improper to sell on symptoms, not diagnosis at any time relating to Risperdal in children and adolescents, can you agree? Let’s agree because it’s so fundamental. Can you agree?
DELORIA: I would agree provided that . . .
KLINE: There’s no provided, sir. That’s what this document says. Does this document have any provided in it, yes or no?
DELORIA: No.
KLINE: The sales force was told to sell on symptoms, not diagnosis. In fact, not only— There’s no wiggle room, is there? There’s just no wiggle room because it says this is what you can’t do and this is you can’t do. It’s two can’ts. You can’t sell on symptoms unless there’s a diagnosis. Can we agree? When you’re stuck, you got to agree.
DELORIA: I’m not stuck, but when we say sell, we’re talking about . . .
KLINE: No, sir. There’s no question pending. No question pending at this point in the litigation. There’s redirect examination. My job— I’m going to ask you one more time and then maybe we can be done. Can you agree if you were given a statement, “Sell on symptoms, not diagnosis,” as to Risperdal in children and adolescents that that would be wrong. Will you agree with us at 4 p.m. today, sir? Yes or no?
DELORIA: No.
Notes: 386
A: I felt uncomfortable, yes.
Q: Could you tell the grand jury about that?
A: I felt that it was something that is not my character. I couldn’t really approach my district manager or my regional business director because out of fear I would lose my job.
Q: You were very concerned about this?
A: Yeah. I have a wife who has a disability. And I have a young daughter. And I needed to keep my job.
Notes:387
JACKS: When you spoke on TMAP, Dr. Shon, or at a continuing medical education conference that Janssen sponsored or funded in some way, isn’t it true that—that Janssen required you to submit your PowerPoint presentation to them for their review and comment?
SHON: No.
Q: That’s not true?
A: That’s not true.
Q: Let me show you Exhibit 310, Dr. Shon. And you recognize this as an email from a woman named Ann Swink to you and others dated February 18th, 2002, subject matter slides for the Janssen symposia on treating schizophrenia. Do you see that?
A: Yes.
Q: This was a symposia that you participated in—
A: Yes.
Notes : 388
Q: —in 2002?
A: Yes.
Q: Well, what it says is Ms. Swink asks you— she says in the third paragraph, “Please have your personal set of slides back to me by March 6th. We will return any feedback CNS might have on your slides to you by March 13th.” Do you see that?
A: Yes, I do.
Q: Let’s read the next sentence—sentence after that. “After Janssen has had an opportunity to review and comment on the slide, we will send you those comments to you by March 25th with final revisions due back to me from you by March 28th.” Isn’t that right?
A: Yes, that’s what it says.
Q: So, sir, doesn’t this email describe Janssen asking to review and comment on your slides before the Janssen symposia on treating schizophrenia?
A: Yes, it does.
Q: Dr. Shon, do you recall attending an outcome research advisory board for Janssen in Scottsdale, Arizona, from February 27th to March 1st, 2000?
A: I attended a couple of things in Scottsdale. It sounds familiar, but I can’t remember the exact name of it.
Q: And Exhibit 317 is a couple of pages from your calendar, plus a check for $3,000 to you at the Texas Department of Mental Health, as well as some receipts and a draft agenda. Do you see that?
A: Yes.
Q: So you personally accepted a $3,000 honorarium for this event?
A: Yes. This includes the honorarium travel.
Q: Why did you think it was proper for you to accept honorarium for this event?
A: Because it— and this is one of the ones that I talked to Cathy Campbell about and she— she said, is this— does this involve anything with your job? Is your— in terms of any projects you’re working on or anything that would influence your particular roles and functions, and I said no, this is primarily an educational program and a program where they get input.
Q: Okay, Well, if you look at your calendar on the first page, it looks like you left on Sunday, correct, on the very first page of that exhibit?
A: Oh, yes.
Q: And then when you have Janssen CNS Summit, it goes through February 28th, 29th and March 1st, and that’s a Monday, Tuesday and Wednesday; is that correct?
A: That’s correct.
Q: But it’s your testimony to the jury that this was not job related?
A: That’s correct.
Q: Did you— how did you record your time?
A: I think I took comp time or something along that line.
Q: If you could look at the times entered for those days that you were at the CNS Summit, could you tell the jury how you recorded your time, please? On the 28th and 29th, how do you record hours worked? Is it eight hours on Monday and eight hours of Tuesday under regular hour work?
Notes: 389
A: Yes, it is.
Q: Okay. On the last page, March 2000, how did you record your time for Wednesday, March 1st? It’s at the top of that.
A: Oh, yes. Eight.
Q: Okay.
A: Eight hours.
Q: So for this trip to Scottsdale, Arizona, in which you accepted a $3,000 honorarium from Janssen from February 27th through March 1st, you not only accepted a $3,000 honorarium from Janssen, but you recorded your time with the State as eight hours of regular time worked, is that correct?
A: That’s what it appears.
Q: You talked with Mr. McDonald about this Exhibit 667, which was a document that you created after the New York Times article came out.
A: Yes.
Q: A couple of the staff actually did it at your direction?
A: Yes.
Q: But you gave them the facts?
A: Or they gathered the facts and we all went over the facts together.
Q: Well, I want to look at page 4, sir, the last full bullet point on page 4. You said that “Dr. Shon did not accept compensation for his time in such cases because Texas state employees are prohibited from accepting compensation for presentations.” Do you see that?
A: Yes.
Q: Now, that’s not true, is it, sir?
A: Well, it was true as far as I— as I recall.
Q: Well, Dr. Shon, you did accept money from Janssen in the form of honorarium. We’re going to go over some of them, but—
A: Yes. That was for— but not in relation to this project.
Q: Well, sir, you say here— Doctor, it’s stated here on Exhibit 667— I take it you reviewed this—
A: Yes.
Q: —before it was finalized—
A: Yes.
Q: —to make sure it was right?
A: Yes.
Q: Okay. Correct?
A: Yes.
Q: It says, “Dr. Shon did not accept compensation for his time in such cases because Texas state employees are prohibited from accepting compensation for presentations, consultation and other work related to their employment with the state.”
A: Yes.
Q: Did I read that right?
A: Yes.
Q: Okay. You know it’s a felony to do that, isn’t it, sir, to accept money as described in— on page 4?
A:Well, I don’t know what level of— it is, but yes, I know that that is not—
Notes: 390
Q: Well, it’s against the law.
A: —appropriate, yes.
Q: All right. And, in fact, you did accept time and again money from Janssen for going out and speaking as a result of work related to your employment with the State of Texas?
A: No, I don’t see it that way. This was not— the— the things that I went to related to my experience as an administrator across the board.
Q: Are you saying that you believe Janssen flew you all around the country and paid you thousands of dollars in honorarium because of your work in the state of California?
A: My work as an administrator for over 20 years, yes.
Q: Let me hand you what we’ll mark as Exhibit 671 to see if I can refresh your recollection about this. Do you see a check dated 1/24/2003 made out to you—
A: Yes.
Q: —in the amount—
A: Yes.
Q: —of $3,000?
A: Yes.
Q: And you received that check—
A: Yes.
Q: —didn’t you, sir? No doubt in your mind about that, right?
A: Yes. Yes.
Q: I’m going to hand you what we’ve marked as Exhibit 672. Now, Dr. Shon, you were participating, according to this document, in the strategic sales planning process. Do you see that?
A: Yes, I see that.
Q: And do you see that you’re— you’re listed on there as the medical director, State of Texas, Office of Mental Health and Mental Retardation?
A: Yes.
Q: All right. No— no mention there of your previous titles, is there, sir?
A: No.
Q: No mention of any work you’ve done for the State of California?
A: No.
Q: You’re there because you’re the medical director for the State of Texas, isn’t that right, sir?
A: I don’t know that that’s the sole reason, but that was my title and that’s what was listed, yes.
Q: Well, certainly a reason that you’re there, you would agree with me on that?
A: Probably, yeah. Probably.
Q: I want to go back to your statement earlier on Exhibit— Exhibit 667 where you— we talked about on page 4 where you said that— or the exhibit was that you did not accept compensation because Texas state employees are prohibited from accepting compensation. But, in fact, sir, you accepted $3,000 in September of 2003.
Notes:391
A: Okay. That’s what it appears.
Q: Well, sir, here’s the thing. I mean, you answered all these questions from Janssen’s lawyer about how various statements in Exhibit 667 were right and accurate and you were trying to correct the record, but when it came down to the money, Exhibit 667 is just flat wrong about that because you did take money from Janssen while you were and on— and on account of your position as a state employee. Isn’t that right, sir?
A: Yes, actually I did. And I did that with other consultations, which we’ve talked about.
Q: But you— you agree that part of it, part of the reason you were being asked— even under your testimony, part of the reason you were being asked was because of your position as medical director of the State of Texas, isn’t that correct?
A: That I was an administrator in the State of Texas as part of my career and that’s part of what I was asked— why I was asked, I’m sure.
Q: Exhibit 674 is some information related to the very summit we were just discussing for which you received $3,000, right?
A: Yes.
Q: It’s the meeting in Amelia Island, Florida, correct?
A: Yes.
Q: Now, one of the things that was discussed at this summit was Risperdal CONSTA, right?
A: I believe so.
Q: Isn’t it true that as a matter of chronology, Dr. Shon, that after you attended the Amelia Island presentation and received $3,000 from the folks at Janssen, a presentation at which CONSTA was discussed, that subsequent to that, the folks from Janssen came to you and talked to you about the idea of putting Risperdal CONSTA on the TMAP algorithm? Is that true or not true?
A: The chronology is correct.
Q: Let me ask you this, Doctor. How many times did Janssen pay for you to go anywhere in the world before TMAP was implemented?
A: I don’t think they did.
Q: How much— how many— how much cash money did Janssen pay you in the form of honoraria or otherwise at any time prior to the implementation of TMAP in Texas?
A: Probably nothing. I don’t recall any.
Q: From last time and from this time, I count six different CNS conferences that you attend for which you received $3,000. Let me run them over with you.
A: Yes.
Q: So three in Arizona that you recall at 3,000 a pop, one in Florida that’s 3,000. That’s— that’s four. We’ve established there’s one in Princeton, New Jersey where you got 3,000. That’s—
A: Yes.
Q: That’s five.
A: Yes.
Q: Dr. Shon, with respect to the thousands of dollars you received from Janssen in connection with these meetings and conferences, what did you do with the money?
A: Deposited them in my personal account.
Q: You didn’t take those honoraria checks and give them to TDMHMR, correct?
A: Correct.
Q: Kept that money for your own personal use, correct?
A: Correct.
Notes:392
Chapter 22: Serious Red Flags
Notes: 393
Chapter 23: A Big Target
Notes: 394
Notes: 395
McCORMICK: Turn to the top of the next page, please, page 261. See where it says, “Risperdal use in the child/adolescent population is exploding?” Is that correct?
GORSKY: That’s what it says, yes.
Q: Then down below, it says, “Key Base Business Goals— Well, strike that. I’m sorry. “Risperdal use in the child/adolescent population is exploding,” but in this time frame, 2001/2002, Risperdal is not indicated by the FDA for any pediatric use, is it?
A: Again, we did not have the specific indication, as we discussed earlier, until 2006. I don’t remember exactly what the labeling said regarding use in children, but as I discussed earlier, there was a significant— there appeared to be a significant increase in the recognition of this condition in children and adolescents during this time, which was substantiated by data and its occurrence. And physicians have an opportunity to use a treatment that they perceive to be appropriate and effective in a particular patient population, and that’s clearly what we were seeing happening in this area.
Q: Look down at the head that says, “Key Base Business Goals and Objectives.” Do you see that?
A: Yes.
Q: And the fifth of the Key Base Business Goals says, “Grow and protect share in child/adolescents.” Is that right?
A: Yes, that’s correct.
Q: My question is, how can Johnson & Johnson grow a share in a child and adolescent market when the drug isn’t even indicated for use in the child and adolescent market?
A: Well, my interpretation of that is, this is in fact a marketing plan, not a selling plan. As a marketing plan, its intent is to cover a wide range of activities regarding the development as well as the promotion of Risperdal. That being said, all of our actual promotion to the physicians would follow what was outlined in our package insert and all of our materials went through a significant review process, and that’s the way our representatives were trained. And in an area such as this, this is a marketer versus a sales representative, their language. And when in fact physicians took it upon themselves and their patients to prescribe the product, their statement would in fact be correct: To ensure that when a physician made that choice, that it was in fact Risperdal.
Q: You were the vice-president of sales and marketing at this time frame, 2000/2001, correct?
A: It depends when this was actually previewed. I don’t know if there’s a date on here or not, but I think that’s the case, yes.
Q: You became vice-president of sales and marketing in December of 1999, correct?
A: My statement related to— I believe I became president of Janssen in late 2001.
Q: Okay. Even if a doctor can prescribe Risperdal for an off-label use and create a market share, you still cannot or Janssen still cannot market the drug to that doctor, a pediatric doctor, for use, can you?
A: To the best of my knowledge, we did not promote the use of Risperdal in that patient vis-a-vis direct promotional programs.
Q: Okay. Even though it says grow the share in child and adolescents on this bullet point as a key base business goal, right?
A: Yes— again, this was a marketing document, not a sales-direction guideline.
Q: Well, it’s a marketing document, but it’s still an internal Janssen document. You don’t think the people in marketing knew that Janssen didn’t have— or Risperdal didn’t have an indication for pediatric use?
A: I’m certain they realized that. And they realize, also, that all of the promotional materials would go through a review process to ensure that they were consistent with our labeling.
Notes: 396
Chapter 24: Ice Cream and Popcorn Parties
Notes: 397
Q: And did you ever at any time have any discussion or any thought in your head that my boy is developing actual breast tissue?
PLEDGER: No. I thought it was the weight gain, and I thought that as long as I kept trying to help him with his weight and exercise, that’s all I could do. I would just have to fight the weight as much as possible. I did not know that his breasts were for any other reason than that.
Q: Okay. And did you at any time know that there was any increased risk, of any kind, of your son developing what we in this courtroom have been calling gynecomastia?
PLEDGER: No. I knew nothing of that— I did not know boys could develop breasts or [if] it was a side effect from the medicine at all.
Q: If you knew that, would you have allowed your son to be on this drug?
PLEDGER: No.
Q: Can you tell that to us absolutely and categorically?
PLEDGER: Absolutely not. I— I can— I can’t fight breast growth. I felt like with the weight gain, we could exercise— You can’t fight something like that. I didn’t even know that was a possibility.
Notes:398
Q: The truth is, there were how many people in the study?
A: 592
Q: And how many had a prolactin-related adverse event, of those 592?
A: 2.2 percent.
Q: Sir, the jury is looking squarely at Table 2, okay. They see that there were 30 who had a— a SHAP, correct? That means . . .
A: SHAP A.
Q: Sir, let’s put aside SHAP A and SHAP B—
A: No, that’s crucial.
Q: —because you invented SHAP A—
A: That doesn’t matter we invent. It’s crucial.
Q: How many patients. How many patients— You know where this is going. You know that I’m going to show you the abstract, and the abstract only shows 2.2 percent.
A: Obviously.
Q: And you also know that that’s misleading?
A: No, I don’t agree.
Q: There’s 592 patients, correct?
A: Yes.
Q: 30 of them had a prolactin-related averse event, correct?
A: Under the— under the definition of SHAP A.
Q: Yes. Under the definition of all the patients, if you took all the patients—
A: No, no. Under the definition of SHAP A.
Q: The definition of SHAP A is all the children in the study.
A: No.
Q: All the children with side effects in the study—
A: No, no, no, no.
Q: Sir, there are 592 patients, correct?
A: Yes.
Q: And there are 30 adverse events, correct?
A: In SHAP A.
Q: And that is 5.1 percent, correct?
A: Yes.
Q: What you do here in the abstract is you take the total number of patients, correct?
A: Yes.
Q: That would be SHAP A?
A: No, no, no.
Q: No, that would be—
A: Total number of patients.
Q: Total number of patients. Yeah.
A: Exactly.
Notes:399
Chapter 25: A Turning Point
Chapter 26: One of the Most Alarming Warnings
Notes: 400
Chapter 27: They Knew They Were a Good Company
Chapter 28: An Epidemic Foretold
Notes: 401
Notes:402
Notes: 403
Chapter 29: Opium Blossoms in Tasmania
Notes:404
Chapter 30: Less Prone to Abuse
Q: Let’s go to the next one. July 29, 2003. This is Page 15, Line 216. Holly Abraham, Oklahoma City. He uses Oxy and MS Contin. Now, let’s stop there. Oxy and MS Contin were Purdue drugs, correct?
A: Yes.
Q: And by 2003, MS Contin was also a generic. Did you know that?
A: I believe so, yes.
Q: Okay. Now, in 2003, this says: Went over Allan study to show that Duragesic offers better patient functionality as well as pain control, right?
A: I see that, yes.
Q: And that’s going about the efficacy of the drug, right?
A: Well, that’s talking to functionality.
Q: Now, next it says: Told me about pain conference he attended. And speaker said patients are putting Duragesic in mouths to get high. Asked if they mentioned abuse of other medicine. Do you see that?
A: I see that, yes.
Q: And he said yes, right?
A: Yes.
Q: So specifically, there’s a doctor asking about abuse of Duragesic and other pain meds, right?
A: Well, he stated it.
Q: And then your rep says: Went over DAWN data, right?
A: It says that, yes.
Notes:405
Notes:406
Chapter 31: Evolve the Value Discussion
Q: By the way, how come after 2008, 2009, you stopped using texts? You’ve referenced next calls. Why did you-all just stop doing this?
A: Because the reps are very busy, and we just streamlined situations so there’s drop-downs now.
Q: Didn’t have anything to do with the fact that Purdue got charged with a federal crime and pled guilty to it for things that were recorded in their call notes?
A: I’m not aware of that.
Q: I mean, you just got busier, that’s why?
A: That’s what I understand.
Notes : 407
Chapter 32: The Pill and the Patch
Notes: 408
Chapter 33: The FDA Goes Looking for a Savior
Chapter 34: Two Terrible Dilemmas
Lanier: So let’s start out this morning with a pretty simple question, I hope: Why didn’t you test the Pinnacle metal-on-metal in people before selling it on the mass market?
Ekdahl: Number of reasons.
Q: Okay. Let’s list them.
A: Okay. So, first of all, the— the— there were predicate devices, Ultima and one-piece metal-on-metal that we were comfortable with.
Q: Wait a minute. So the first reason is y’all were comfortable with other devices?
A: Our own predicate devices.
Notes: 410
Q: Comfortable with other ones. These are different ones?
A: They’re the predicate devices.
Q: Excuse me. These are different devices, right?
A: There are some differences, yes.
Q: Okay. So you were comfortable with different devices. So you didn’t feel like you needed to test this one?
A: Devices—
Q: Okay. What were the other reasons you didn’t test it before you sold it?
A: There were other metal-on-metal devices in the market that had been performing well.
Q: Okay. So—
A: —in particular—
Q: I didn’t mean to interrupt you. I apologize. So because your competitors could make them that work well, you assumed yours would. Is that what I’m hearing?
A: No. I’m saying that there were other devices that worked well that we had tested as well—
Q: Wait. Wait. Wait though. You said Sulzer and I thought you said competitive devices. In other words, your competitors had devices on the market, and you assumed that you could make one that would work as good as theirs. Is that what I’m hearing?
A: Sulzer had a metal-on-metal device—
Q: You’re talking about the Metasul?
J & J lawyer: I don’t think he was finished with his answer.
Lanier: I didn’t mean to interrupt. Are you talking about Metasul?
Ekdahl: I’m talking about Metasul as a metal-on-metal that was available.
Q: With a poly liner between the metal cup and metal liner?
A: Yes.
Q: So competitors had a product on the market, and you assumed yours would work as well as theirs?
A: Correct.
Q: And did competitors have a 36-millimeter on the market?
A: I believe— I’m going from memory, so forgive me. I believe Biomet had a 36- or 38-millimeter device—
Q: But this—
A: —approved.
Q: But the Sulzer— Look, we’ll talk about the competitors in more detail in a minute.
A: Okay.
Q: But just right now let’s make a little note on this extra page I’m using. The Sulzer Metasul that you’re saying worked well had a— was a different device that had a poly insert in between the cup and liner, right?
A: That’s correct.
Q: And it was 28 millimeters. It wasn’t the large one that y’all were trying to sell, was it?
A: I believe it was 28 and 32.
Q: And y’all were looking to sell 36, weren’t you?
A: Well, we had 28 and 36.
Notes:411
Q: 36 was your principal seller. That was your big market?
A: It was the one mostly prescribed, yes.
Q: Okay. So competitors had some, and so you didn’t feel like you needed to test yours because the competitors were selling theirs so surely they had tested theirs?
A: I’m giving you all of the information here.
Q: Yeah. Any other reasons y’all didn’t test it?
A: We had significant bench testing, our own wear simulator testing that—
Q: Right. But that’s not in people.
A: No. That’s correct.
Q: That’s not going to tell you what the result of the debris and ions are in people, is it?
A: No. But it’s going to help you understand the amount of wear that may or may not be generated.
Q: No question about that. I’m asking about the effects in people. You understand that— that’s the concern in the trial, right?
A: I understand.
Q: In other words, your concern is not when you put this in a machine and you do a back and forth same process a million times how much is left in the liquid of the debris; our concern is what effect does the debris and ions have in people when people have it in them. You understand?
A: No, I understand.
Q: All right. So that’s my question, is: Why didn’t you test it in people? The simulator is not going to give you any results of what the metal ions can do in people, right?
A: That’s correct.
Q: Okay.
A: But it’s part of the body of evidence that I’m using— I’m answering your question.
Q: Okay. The simulator showed debris. What else? Any other reasons that y’all did not test it in people before you sold it?
A: The— I’m sorry. I’m again going from memory here. I think— The other piece I think that it’s important to understand is this is exactly the same process as polyethylene-on-metal—or sorry—the metal-on-polyethylene, the Marathon product.
Q: Wait. You’re saying you didn’t test the Pinnacle metal-on-metal because you don’t test any of your products on people; is that what I’m hearing?
A: No. I’m saying that would be another example— I’m saying that we went through the same process for metal-on-metal as metal-on-poly.
Q: All right. The fourth reason is y’all just don’t test any of your products in people?
A: And then I think the final piece is that this is a process that’s used for essentially all devices. I guess what I’m saying is we followed the industry norm of testing devices with our predicate devices, looking what our competitors had, using simulator data. We followed that with Marathon. And then overarching all of that, that is industry norm.
Notes:412
Q: Okay. I’m trying to figure out have you just bled through two of them in one or do I need to write them both down? Are you saying that y’all didn’t test your other devices either? You didn’t test your Marathon so why should you test metal-on-metal? That was a reason? Y’all just don’t test your products before you sell them?
A: No.
Q: I mean, should I write that down, we don’t test our plastic either? Do you want me to write that down as one of the reasons y’all didn’t test it?
A: I’m just saying we didn’t test the plastic either.
Q: All right. So don’t test a lot of stuff.
A: I wouldn’t characterize it like that.
Q: Well, I mean, you had Marathon in multiple sizes. I’m assuming you’re saying you didn’t test any of that. Am I right?
A: We tested it. We tested it in simulators, we tested it—
Q: In people.
A: So let’s— That’s correct. We— we did not test it in people.
Q: Okay.
A: But we tested.
Q: And then the fifth reason was you didn’t think anybody else tests it. Nobody tests.
A: I’m just saying there is an industry norm around using all of these various tests in predicate devices for new products.
Q: In other words, you’re saying nobody tests. Do you really want to say that under oath that nobody tests their products other than—
A: I didn’t say.
Q: Okay.
A: You said that. I didn’t say that.
Q: All right. Good. Let’s cross that out then. Let’s don’t say nobody tests. Now, don’t test a lot of stuff.
A: I disagree with that because we do test.
Q: In people. We’re talking about in people. See, I’ve underlined “in people.” That’s the only thing I’m asking you.
A: A lot of our products aren’t tested in people.
Q: People. Well, then we need to keep that on there. You don’t test a lot of your stuff. You just said, “A lot of our products aren’t tested in people.” So we’re going to keep that now, right?
A: In people.
Q: Okay. You understand, I’ve written this down so we can all see it together. Do you understand I’m asking you why you didn’t test it in people? That’s the only thing we’re concerned about right here. All right?
A: I understand.
Q: So you don’t test a lot of your stuff in people, right?
A: That’s correct.
Q: All right. Now, simulator showed debris. Competitors had some metal-on-metal products. Of course, all metal-on-metal is not the same, right?
A: That’s correct.
Q: All right. We know that all metal-on-metal— In fact, your company ade a big deal out of this, telling the world this. All metal-on-metal is not the same, right?
A: That’s correct.
Notes:413
Q: In fact, one reason y’all sold your ASR XL here in the U.S. without testing it on people is because you were comfortable with the Pinnacle. And you said ASR and Pinnacle are the same thing, right? For safety and efficacy?
A: I’m not sure. Did I say that? I didn’t say that.
Q: Well, the company said that. The company swore to the FDA that ASR had the same safety and efficacy as Pinnacle.
A: I’m not sure what we say.
Q: All right. Well, let’s do it this way. Can I suggest to you that maybe you’ve left out the real reason why? The real reason why is it’s all about money?
A: I disagree with your statement, so—
Q: It would have cost y’all money to test and it would have cost you profits and market share to take the time to test the Pinnacle metal-on-metal in people. True?
A: I disagree with you.
Q: Okay. We’re going to go through that, and we’re going to look at it together then. By the way, to test that— Let me ask you this question: What was the downside to testing it in people? Let’s— let’s weigh the downside. Can you tell that to the jury, please?
A: I’m not sure what we would have learned.
Q: Okay. So one downside is you don’t know that— you don’t know the answer to the testing before you test it. Don’t know answer before you test it. But that’s not a downside. That’s why you test it, isn’t it? Can you answer that question I just asked, sir?
A: I’m sorry. Can you ask it again?
Q: Yeah. Your suggested answer number one is you don’t know the answer that testing might show before you test it. In other words, I don’t know what it would have shown. Isn’t that why you test something, because you don’t know the answer?
A: No, I’m— I’m saying, Mr. Lanier, I don’t know what testing we could have done and what it would have shown. I don’t— I’m not an expert in that. I don’t know how to answer the question, to be candid.
Q: But, sir, if you don’t know what the testing will show, you don’t know the results of the testing, that’s a reason to do the tests, isn’t it?
A: I don’t even know how to answer that. I apologize.
Q: That’s okay. Can you think of any other downside to testing other than you wouldn’t know what the testing would be or would show?
A: Off the top of my head I don’t know how to answer the question. I apologize.
Q: Well, there are other reasons— a downside to testing. One is you’ll lose market share because you’ve got competitors that are beating you out there. Right?
A: I don’t think so, no.
Q: You don’t think you would lose market share
A: No.
Q: And you would lose profits that come from that selling?
A: I disagree.
Notes: 414
Lanier: So y’all changed the clearance and didn’t tell the truth to the FDA. Correct?
Turner: No.
Q: Ma’am, y’all changed the clearance?
A: We did change the clearance.
Q: You changed the clearance in the countdown, didn’t you?
A: We changed the clearance.
Q: And you didn’t tell the FDA you changed the clearance, did you?
A: We told them we had the same effective radius.
Lanier: Objection, nonresponsive.
Judge: Sustained.
Lanier: Ma’am, do you know the difference between “clearance” and “effective radius”?
Turner: Yes.
Q: Answer my question about the clearance then. Okay? And don’t pivot to the effective radius.
A: I’m just trying to tell the whole truth here. I’m sorry.
Q: Okay. Well, the whole truth starts with answering the question, ma’am, so answer the question. Do you need Pam to read it back?
A: Did we mention the clearance? No, we did not mention a change in the clearance, if that was the question.
Q: Yes, ma’am. Because the jury got to hear from you and Mr. Quattlebaum talking about your submission to the FDA. Do you remember that?
A: Yes.
Q: And you never showed ’em the chart that y’all gave to the FDA, did you?
A: I don’t remember if we showed the chart or not.
Q: Because there was a chart, wasn’t there?
A: Yes. The chart I referenced.
Q: Defendant’s Exhibit 467. This is what you gave to the FDA, isn’t it?
A: Yes.
Q: The FDA has a device description, and it’s got articulation requirements. Do you see that?
A: Yes.
Q: And we’ve got a column here for the 28-millimeter and we’ve got a column here for the 36-millimeter. Correct?
A: Yes.
Q: So we can see the 28-millimeter, 40 to 80 microns clearance. Do you see that?
A: Yes.
Q: And this is what you swore to or verified to the FDA.
A: It was part of a document, yes, an affidavit that I signed, yes.
Notes: 415
Q: And then for the 36-millimeter you swore to the answer being the same, even though the truth of the matter is it wasn’t. Correct?
A: Based on the date of that document, that is the correct information. The wrong table with the date of the 13th was not submitted.
Lanier: Objection, nonresponsive.
Judge: Sustained.
Lanier: Ask the witness be instructed to answer, please, Your Honor.
Judge: Answer the question, please, ma’am.
Turner: I’m sorry, can you please repeat the question?
Lanier: Yes, ma’am. What you gave to the FDA was false?
A: Inconsistent. This table is incorrect information.
Q: That’s what—
A: Yes.
Q: “False,” you know what it means. Ma’am—
A: Yes.
Q: —do you know what false means?
A: Yes.
Q: It means not true; incorrect; or wrong, is the primary meaning. Do you see that?
A: Yes.
Q: So this was false by the primary meaning of the word, wasn’t it?
A: That is, yes.
Q: So you gave false information to the FDA.
Notes:416
Lanier: Well, option 1 was “Continually grow the complaint department to match the upward trend.” Y’all did not choose option 1, and you never grew the complaint department out of this, did you?
Plouhar: I— I would— I think I disagree.
Q: You think you did?
A: I think I— I disagree, yes.
Q: Are you suggesting that the two Kelley temps were the growth of the department, complaint department, not adequately resourced? Use of Kelley temps in permanent roles.
A: That’s what the document says. I think that was a statement of what the current state of the department was.
Q: So option 2, you don’t think y’all chose. Ma’am, isn’t it appalling that y’all would even put down as an option to retrain the sales force not to report every revision? Isn’t that appalling?
A: It’s an option. I think that we were trying to identify what the options were.
Chapter 35: God, Nazis, and Hip Implants
Notes:417
Notes:418
Lanier: You’re saying that the doctor sat on it and didn’t give the information to the company. Is that what you’re saying?
Plouhar: We did not have the case report forms.
Q: I’m sorry, ma’am, is that what you’re saying?
A: I’m saying that they were not reported to the company.
Q: You understand some of these doctors that y’all claim wrote this paper (indicating) are the same doctors that you’re saying sat on the information and didn’t give it to you.
A: I’m saying that we did not have all the case report forms.
Lanier: Objection, nonresponsive.
Judge: Sustained.
Plouhar: We had not received the case report forms from the sites.
Lanier: Ma’am, that still wasn’t my question. I said you understand the doctors that you say wrote this paper are some of the very doctors that you’re now saying they never told us about the data.
A: I’d have to look in detail at the case reports. I don’t know which surgeons submitted the case report forms. I know—
Q: Dr. Barrett was one of them?
A: Yes. Dr. Barrett was one.
Q: So Dr. Barrett himself, if he truly wrote this paper, you sure would think he doesn’t have the excuse of saying, well, I didn’t know that I’d revised that hip?
A: I don’t know. You would have to talk to Dr. Barrett.
Notes:419
Q: I mean, but you’re sitting here telling— By the way, you won’t agree this was ghostwritten, even though y’all ghostwrote it?
A: It was not ghostwritten.
Q: Yeah. You think Dr. Barrett actually wrote this paper?
A: He participated in it.
Q: He didn’t write a word of this paper, did he?
A: He participated in it.
Q: By participated, you’re telling us he hid his revisions from you?
A: No.
Q: Did y’all know about his revisions?
A: We knew that he had a case that had been revised for infection.
Q: Did y’all know about the other revisions, or did your investigators hide ’em from you?
A: I don’t think that they were hiding them from us. Sometimes it just takes time to get data.
Chapter 36: Never Stop Moving
Notes: 420
Lanier: If I buy a, I don’t know, if I buy an iPhone and it doesn’t work or a Galaxy phone and it catches on fire and I take it back and they swap it for one that works, y’all don’t swap it for one that works, y’all sell ’em another one, don’t you?
A: Yes.
Q: So everyone that has the metal-on-metal revision just needs a new one just buys it from you. That’s the system you’ve got, right?
A: I disagree. They could buy it from everybody. They could buy all the parts.
Q: Sir, you know there’s a lot involved in cutting out this cup?
A: Yes.
Q: This cup’s got this real weird-looking rough stuff on the back because it truly grows straight into the bone, doesn’t it?
A: Yeah. The bone grows into it.
Q: So surgeons don’t take these things out lightly. That involves destroying bone and doing a whole lot of work, right?
A: Correct.
Q: But y’all have come up with a system where the surgeon doesn’t have to take it out. He just pops out the metal liner, pops off the metal ball, puts on a new ball, puts in a poly liner, and life goes on.
A: Yeah. Modularity is in demand from surgeons.
Notes:421
Chapter 37: A Cure for Sag
Notes:422
Chapter 38: “Usually Minor and Well Manageable”
Chapter 39: A Rare Shot at Redemption
Notes:423
Notes: 424
Notes:425
Notes: 426
Notes:427
Q: It’s a very general statement, but they should abide by the regulations and rules.
Q: Sir, this is a simple— I promise you, it’s not a trick question. Drug companies should be honest with the public, right?
A: Again, honesty is a very broad term. I would say they should abide by the regulations and rules.
Q: Okay. That’s— In fact, I am going to write that one down so I remember it. ‘Honesty is a broad term.’
Q: These numbers are not in the letter to the editor, are they, Dr. Coppola?
A: No, it—
Q: They are not, correct?
A: Dr. Bilker didn’t for whatever reason put them in the letter.
Q: We have in the letter— and maybe we can put these side by side. I don’t know if it will work side by side, but you and I can agree that those results did not make it into the letter to the world to see, correct?
A: Correct.
Q: They were not provided to the Food and Drug Administration, true?
A: Correct.
Q: They have not been provided as far as you know to Dr. Findling and Dr. Daneman?
A: I have no idea. I assume that Dr. Bilker shared all of this information.
Q: They have not been provided to the journal, correct?
A: No.
Q: Right here in this book, what we are seeing are different numbers than what were in the published paper, correct?
A: Yes.
Notes:428
Q: Do you remember way back when we started your discussion when we discussed lying? About scientific misconduct? We talked about a drug company should avoid scientific misconduct, correct?
A: Correct.
Q: You told us that was a 10, correct?
A: Yes.
Q: One of the things that was included in scientific misconduct was hiding data, correct?
A: Yes, and I— I never saw— I don’t know what this data—
Q: Let’s be real clear, right? The reason for this whole letter to the editor besides litigation is because Table 21 was never turned over way back when in 2003, correct?
A: No.
Q: Table 21 was never part of the original analysis, correct? It’s not in the original Findling article?
A: It’s not in the original Findling article.
Q: Okay. Daneman, we see multiple emails, and others, that were upset about, at least from their perspective, not being provided with Table 21, correct?
A: Yes, I think we’ve established that.
Q: We talked about when it was time to get this letter to the editor done, to get it sent out, especially send it to the FDA, err on the side of over-inclusion, right? Be transparent? We talked about that just a few minutes ago, right?
A: Yes.
Q: And here we are looking at data or were looking at data a moment ago that was never included in the published results, correct?
A: Yes.
Q: We saw emails about “Refute Table 21.” Do you remember that?
A: Yes.
Q: We talked about the way to refute Table 21 is to make the significance go away, do you remember that?
A: Yes.
Q: Hiding data is not an acceptable way to refute Table 21, is it, ma’am?
A: No.
Q: Ma’am, I started your cross examination by asking you two simple questions. I’m going to try it one more time. In the course of all we’ve gone through over the last couple days, have you seen any conduct by Janssen that you feel is the type of conduct that should be deterred?
A: No.