THE VIDEOGRAPHER: We are now on the record.
My name is Andrew Smith, and I'm the videographer for Golkow Litigation Services.
Today's date is February 26th, 2020, and the ce) time on the monitor is 9:07 a.m. This video deposition is being held at Hampton Inn and Suites, 3934 Grandview Drive, Simpsonville, South Carolina 29680, in the matter of Barry Staubus v. Purdue Pharma et al., for the court of the Circuit Court for Sullivan County at Kingsport, Tennessee.
The deponent is Todd E. Dean.
Counsel all counsel will be noted for the stenographic record.
Will counsel please identify themselves.
MR. GASTEL: Ben Gastel on behalf of the plaintiffs.
MR. BUEKER: Good morning.
John Bueker on behalf of Mallinckrodt and the witness.
MS. SORICELLI: Jess Soricelli on behalf of Mallinckrodt LLC and the witness.
THE VIDEOGRAPHER: The court reporter is Karen Kidwell, and will now swear the witness.
MR. GASTEL: Thank you.
MR. BUEKER: Before we begin, let me just note for the record that this deposition was actually noticed for the Holiday Inn Express and Suites, at 642 Fairview Road, Simpsonville, South Carolina, 29680.
That's not where the deposition is in fact taking place, so I'll ask the court reporter to mark as Exhibit 1 to the deposition the Plaintiffs' Amended Notice of Deposition.
And I'll state for the record our objection to the deposition, and I'll state for the record that any time that was wasted coming over here will count against the Plaintiffs in term of the presumptive 7-hour limit.
MR. GASTEL: First of all, there's no 7-hour limit in state court in Tennessee, as the Defendant should know, since the deposition that I attended on Monday was like 8 and a half hours on the record.
With that being said, it's not really going to matter.
We're not going to be here all day.
I apologize for the mixup.
WHEREUPON,
TODD E. DEAN,
being first duly sworn, testified as follows:
EXAMINATION
BY MR. GASTEL:
Q     Notwithstanding what your counsel just Said, are you prepared today to give a deposition in the case that was noted on the by the videographer?
A     Tam. ) Q. And I was going to mark as Exhibit 1 the notice of deposition anyway, so we can go ahead and mark that.
(Exhibit 1 was marked for identification.)
BY MR. GASTEL:
Q     And you understand that we're here today pursuant to the notice that was identified as Exhibit 1 by your counsel?
A     I do.
Q     And you understand you're here to give sworn testimony in that case?
A     I do.
Q     Where do you live, sir?
Q     What is your address?
A     | *Redacted - PII.
Q     How long have you lived there?
A     I believe right over 12 years.
Q     Who lives there with you?
A     My wife and three sons.
Q     Do you have any plans to move any time soon?
A     No.
Q     When did you first learn that you would have to sit for a deposition in this case? ce) A. I don't recall. It's probably right at 30 days ago.
Q     I understand that this deposition was supposed to go a couple weeks ago, and then you had requested that it be moved as a result of some work obligations; is that fair?
A     sure.
Q     I don't want to know anything that you might have said to to one of your lawyers, but I do want to know: When was the first time that you talked to a lawyer about the subpoena that you were served with in this case? AY Yesterday.
Q     And what and again, I don't want to know what was said in any conversation with counsel. But what did you do to prepare for today's deposition?
A     Really not much. I was just gaining context yesterday, more than anything, based on, you know, what's taken place to date.
Q     And it sounds like you met with counsel again. I don't want to know what happened in that meeting.
A     Yeah.
Q     But where was it? Was it in person or on ce) the phone?
A     In person, here in Simpsonville.
Q     How long was that meeting?
A     I don't recall exactly.
Q     Was it an hour, two hours, three hours?
A     Probably two and a half, three hours.
Q     You're no longer employed by Covidien/Mallinckrodt, correct?
A     Correct.
Q     I understand that when you were working for Mallinckrodt, who was part of Covidien, is that fair?
A     Yeah. It was under the Covidien name.
Q     But you understand that that that that entity that you were working for is now sort of operating under the Mallinckrodt name? Are you aware of that?
A     I'm aware of that, but that was post my leaving the company.
Q     T understand that. So throughout today's deposition, I might use the term "Covidien" or "Mallinckrodt," but do you understand that what I'm referring to is that entity that you worked for from approximately June 2011 to February 2013?
A     Generally, yes. ) Q. So can we have that understanding throughout today, that if I use those
A     Yes.
Q     two terms, I'm kind of using them interchangeably?
MR. BUEKER: ‘Todd, I'm just going to break in here for a second.
As Ben's asking you questions, the court reporter is taking it down.
And in order for her to take down what's being said, you can't talk over each other.
THE WITNESS: Okay.
MR. BUEKER: So just let him finish, and then give your answer.
THE WITNESS: Okay.
BY MR. GASTEL:
Q     Are you represented by counsel today at porn "Redacted - EPI |
Q     Okay. Well, then you're probably a little bit familiar with the dynamic, but I'll just say this: Any time you need to take a break today, sir, just let me know. If there's a question pending, I'm ) only going to ask you to answer that question, then we can go take a break. If you need a drink, you need to go to the bathroom, or whatever. Okay?
A     Okay.
Q     Otherwise, I'm going to go kind of quick, because I don't think anybody wants to sit in this conference room all day, and I'm going to try to go as quickly as possible. But you've just been handed a document that's been marked as Exhibit 2?
A     Uh-huh.
Q     Are you familiar with this document, sir? AY Yeah.
Q     This is your LinkedIn profile, right?
A     Right.
Q     Did you input this material into LinkedIn to sort of show your professional work?
A     Yes.
Q     It shows that you've been working at Ob Hospitalist Group for approximately seven years. Is that accurate?
A     Yes.
Q     And was that the job that you took after you left Covidien?
A     That's correct. ce) Q. I don't really want to spend too much time on this, but can you just give me a just a broad overview of what you do for the Ob Hospitalist Group?
A     Sure. So I'm a vice president of business development. I call on hospitals. We contract with over 180 hospitals across the country, and essentially we provide physician services in the labor and delivery department with partner hospitals, to provide a higher level of care 24/7 on expecting mothers.
Q     Okay. And is that because obviously mothers give birth kind of they they don't they don't respect holidays, they don't respect nights, and so it's hard for hospitals to kind of get coverage for late night for OB/GYN care?
MR. BUEKER: Object to the form.
THE WITNESS: Yeah, I wouldn't I wouldn't use the terminology a patient doesn't respect when when to have a baby.
But no, it is a patient safety and care initiative, with a a more acute level of care to the patient S in a timely manner.
BY MR. GASTEL:
Q     Okay. And has that been your role since you joined them seven years ago? Or has it changed ce) over that time?
A     That's been my role.
Q     So is it fair to say that you're no longer working in the pharmaceutical sales space?
A     That's correct.
Q     And then on your LinkedIn profile here, it shows that you were the specialty pharmaceutical specialty pharmaceuticals manager for Covidien from June 2011 to February 2013.
A     I believe that's correct.
Q     So that's approximately 21 months?
A     I believe that's correct.
Q     And it shows that you were you you put on here that this reference to the Presidents Club and that you were a Presidents Club Specialty Manager Award recipient. What is that, sir?
A     Essentially and again, this is close to eight years ago, but of the 15 to 20 districts they have across the country, they're looking for performance-based and often that's around metrics such as growth, as well as performance of individuals on the team that you lead. And I think they identified three of the 15 to 20 districts in that regard.
Q     So does that mean that you were kind of ) heading up one of the top sales districts for Covidien at that time?
MR. BUEKER: Objection.
Form.
THE WITNESS: Certainly not within the first year, but the last portion of when I was there, I would say yes.
BY MR. GASTEL:
Q     And the specialty pharmaceuticals manager put you on the branded side as opposed to the unbranded side; is that fair to say?
A     Strictly branded.
Q     Do you recall the drugs that you were principally responsible for on the branded side during that time?
A     Yeah. It was just two. It was Pennsaid and Exalgo.
Q     Pennsaid treats migraine headaches?
A     No. Pennsaid is an NSAID. It's a topical pain reliever. And Exalgo is an extended-release therapy for chronic pain.
Q     Tt's an opioid, right?
A     Yes.
Q     Is there a reason why you decided to leave pharmaceutical space and go to the Ob Hospitalist Group? ce) A. Opportunity. The fact that the company Ob Hospitalist Group is based right here in Greenville, South Carolina, *Redacted - EPI. *Redacted-EPI = evarything 1 do today is appointment-based, so when I leave town, it's very much I know where I'm going. I come back home. And I make considerably more money than I ever did in pharmaceuticals.
MR. BUEKER: Why did you leave?
BY MR. GASTEL: 7 re -*Redacted - EPI
A     Uh-huh.
Q     I want to talk a little bit about the obviously today's deposition is going to almost exclusively focus on the 21-month period when you were at Covidien. So I want to talk a little bit about sort of the structure of the sales team. Who in the sort of organizational chart did you report to? Who was above you?
A     Bill Nichols. He was a regional director.
Q     Did you sometimes refer to yourself as the district manager? ce) A. I think that was the term used.
Q     And as district manager, you had a sales team under you that you managed; is that fair?
A     Uh-huh.
Q     I need a verbal response, sir.
A     Yes.
Q     And during that 21l-month period, do you remember the the geographic region that your sales team covered?
A     Generally, all of South Carolina, where I preside. Western North Carolina. A little bit in Northeast Georgia, and a little bit in Eastern Tennessee.
Q     Did that include the Knoxville region?
A     It did.
Q     And was that true for your entire 21-month period?
A     I think the tail end of it, there was some restructuring of the geography, and there was a portion of that that went to a North Carolina manager, which is not uncommon in pharmaceuticals. I mean, they restructure districts often yearly.
Q     As district manager, would you occasionally go and ride along with the sales folks under on your team to do ride-alongs and see how ce) they were operating in districts?
A     Yeah, but it was pretty rare. I mean, I had I think at the time 12 people in the district, so you're not spending a lot of time with any one person.
Q     Do you recall ever doing one of those ride-alongs to see a doctor in Tennessee?
A     sure.
Q     Do you remember how many times you were in Tennessee?
A     I don't.
Q     Do you remember any of the doctors that you that you personally visited during those sales trips?
A     I don't. I mean, because I dontt personally call on them. I mean, the the reps would know them by name. I I don't recall.
Q     Did you ever keep a log of like those trips, or any type of notebook to kind of help you remember where you went?
A     No. Not in that regard.
Q     I think you said you had 12 people on your sales team?
A     Uh-huh. Yes.
Q     Do you remember their names? ) A. Every single one of them, at this point, no. And there was an evolution from when I was hired. In the short time I was with the company, I think there was three to four of them that initially were on the team that were no longer on the team during my time, for a number of reasons. And I mean, I could rattle off some, but I don't I don't recall all their names.
Q     Sure. Eric Hichman?
A     Yes. QO. Chris Clark?
A     Yes.
Q     Teresa Crawford?
A     Yes.
Q     Cheryl Herbold?
A     Briefly.
Q     Do you have any understanding about the nature of the claims in the in this lawsuit?
A     Not really. I mean, generally.
Q     Have you been following any of the news on opioid-related lawsuits across the country?
MR. BUEKER: Objection.
THE WITNESS: Not really.
BY MR. GASTEL:
Q     Did you see in the news yesterday about ce) Mallinckrodt's announcement of a pending Chapter 11 filing?
A     I did not.
Q     Do you have any understanding of I'm going to call it the opioid epidemic. Your counsel might object to that, but what is your understanding of the opioid epidemic in this country?
MR. BUEKER: Objection.
Form.
THE WITNESS: "Understanding" is broad.
I don't really know what you mean by that.
BY MR. GASTEL:
Q     Well, do you have any understanding of problems with opioids in this country?
A     I do. It's talked about a lot on the news, but...
Q     What do you recall seeing on the news?
A     Just generally that there is an epidemic with overutilization of opioids.
Q     You understand that that relates to prescription opioids?
MR. BUEKER: Objection.
S THE WITNESS: Not really.
I think it's a combination of street use and those that are written, you know, appropriately, with providers and potentially diverted.
BY MR. GASTEL:
Q     You used the term there "diverted." What is your understanding of diversion?
A     Broadly, I don't really understand it, other than the fact there's probably prescriptions written for patients complaining of pain that then divert those therapies to either family members or others that they potentially either give and/or sell to.
Q     And was that your understanding when you were working for Covidien back in 2011 to 2013?
MR. BUEKER: Objection.
THE WITNESS: It was a learned, I would say, understanding.
So I didn't understand it when I first started with Covidien.
I certainly didn't take the job knowing that.
BY MR. GASTEL:
Q     Are you done?
A     To am.
Q     I understand your testimony that you learned learned about diversion while you were at Covidien. You didn't understand it when you first got there, but
A     Uh-huh. ce) Q. through the course of your employment you came to that understanding?
A     Came more to that understanding, based on feedback from representatives in the field.
Q     And that would have been the the representatives in the field that were under your supervision?
A     Not just my supervision. I think it was talked about. But yeah. I mean, I think it was varying degrees of what people's thought of diversion may be.
Q     What is your understanding of what opioid abuse 1s?
MR. BUEKER: Objection.
Vague.
THE WITNESS: Yeah, I don't know what you would define as "abuse."
BY MR. GASTEL:
Q     Well, I guess maybe I'll let you define what opioid abuse is, if you have a definition.
MR. BUEKER: Objection.
Vague.
S THE WITNESS: I don't I don't really know.
I'm number one, I'm not a prescriber.
Number two, abuse could be within a PI.
It could be outside of a PI, meaning prescribing information.
BY MR. GASTEL:
Q     What do you mean by "prescribing information"?
A     That is a FDA term that is legally, my understanding, approved based on the pharmacokinetics and pharmacologics of a therapy. So every drug goes through the FDA for review before it's put on the market, and has clinical trials to support why it should be even allowed on the market, that the FDA reviews and then approves by the government.
Q     As someone who worked in pharmaceutical sales, is it fair to say that you were aware of an opioid diversion issue in Tennessee?
MR. BUEKER: Objection.
THE WITNESS: Generally aware, like I'd mentioned, that the reps brought that to my attention over time, in their opinion.
BY MR. GASTEL:
Q     When you were working for Covidien, did you ever happen to look up opioid prescription rates in the state of Tennessee?
A     I never did. You're talking about personally, just like data-search that?
Q     Yeah.
A     No.
Q     Did you have ever have conversations with your sales representatives working in Tennessee about concerns related to opioid abuse in Tennessee?
MR. BUEKER: Objection.
Vague.
THE WITNESS: I think that they would typically bring what they perceived to be challenges in the state of Tennessee, and there would be discussion back and forth.
BY MR. GASTEL:
Q     And what do you recall about those discussions? AY Frankly, eight years ago, not a lot.
Q     And I understand that you're not going to recall precisely the conversation. But what what, if anything, do you recall about the conversations?
A     Generally that they they were concerned that they were in a market space where there was I wouldn't even use the word "diversion" as much as just challenges, because they knew there was a lot of patients on opioids in general. And so it could be just day-to-day awareness and their sharing information based on a, you know, particular instance that they may have run into.
Q     While you were at Covidien, do you recall ) receiving special training on how to identify problematic opioid prescribers?
A     Not training in that regard. We had training such as the REMS program and different safety pharmacologic, pharmacokinetic effects of the drug. But it it really wasn't training on identifying problem providers.
Q     Do you recall seeing anything troubling on the physicians or pharmacies that you visited in Tennessee?
A     That I visited?
Q     Yeah. AA, No.
Q     Would you agree that as early as 2011, Tennessee had been plagued by lenient laws that led to the state being flooded with pill mills?
MR. BUEKER: Objection.
THE WITNESS: Boy, that's a Lot to unpack.
"Flooded" and "pill mills." So can I ask you to restate the question?
BY MR. GASTEL:
Q     Sure. Would you agree that as early as 2011, Tennessee had been plagued by lenient laws that led to the state being flooded with pill mills?
MR. BUEKER: Objection.
THE WITNESS: Yeah, my only understanding as I came on board in 2011, as I learned about my specific reps bubbling concerns up.
BY MR. GASTEL:
Q     And what were the concerns that were bubbling up?
A     Just that there was an overuse of opioids within the state, based on state laws.
Q     Do you remember what reps brought that to your attention?
A     Those who worked in the state of Tennessee.
Q     Chris Clark: Was he one of them?
A     Yes. QO. Was Eric Hichman one of them?
A     I don't believe Eric went into Tennessee. I could be wrong on that. He was a Western North Carolina representative.
Q     He's at Asheville?
A     Right.
Q     I talked to him last year. Did you believe that pill mills were operating in Tennessee as early as 2011?
MR. BUEKER: Objection.
THE WITNESS: I mean, generally the ) term "pill milis," I don't know what you refer to when you when you refer to a pill mill.
BY MR. GASTEL:
Q     Well, how do you define what a "pill mill" is?
MR. BUEKER: Objection.
THE WITNESS: I really don't know.
It's a vague term to me.
BY MR. GASTEL:
Q     You didn't have an understanding of what a pill mill was when you were the sales representative for or I'm sorry, the the general manager let me start over. You didn't have an understanding of what a pill mill was when you were the district manager for Covidien Specialty Pharmaceuticals?
A     No. As I mentioned, it was a term I think that was used by people as to their interpretation that was brought to me. But that's a broad term. I IT don't know that there's a a true definition of what a pill mill is.
Q     Well, in your mind, what is a pill mill?
MR. BUEKER: Objection.
Asked and answered.
THE WITNESS: I don't know that it's ) really something I can define.
BY MR. GASTEL:
Q     Do you think that it carries a positive connotation?
A     I wouldn't want to assume on that.
Q     Were you ever told by Bill Nichols or any of your superiors to treat physicians, pharmacies, or nurse practitioners in Tennessee differently than in other states within your territory?
A     No. QO. Have you ever reviewed any materials from the Tennessee Department of Health regarding Tennessee's opioid abuse problem?
A     No. QO. Did you ever receive any information from any source about Tennessee being plagued with problems with opioids or pill mills?
MR. BUEKER: Objection.
THE WITNESS: No.
BY MR. GASTEL:
Q     You would agree with me that Covidien directly marketed to Tennessee prescribers and pharmacies in promoting its branded opioids, right?
MR. BUEKER: Can I hear that read back, please. ) (Whereupon the Court Reporter read the previous question.)
MR. BUEKER: Objection.
Lack of foundation.
THE WITNESS: I would say yes.
BY MR. GASTEL:
Q     And how were those promotional efforts done?
A     I mean, generally, at the local level, representatives would represent Exalgo in this case it's the only opioid that we had based on the prescribing information provided to them, which they would share with a physician.
Q     And they would do that through in-person visits, right?
A     Most of the time, yes.
Q     And that means that they would physically go into a prescriber's office and try to meet with the health care practitioner who had prescription powers?
A     Most of the time. I mean, they can also meet off site.
Q     And they would commonly buy food, like breakfast or lunch, when they were coming in for an office visit; is that fair?
MR. BUEKER: Objection.
THE WITNESS: I wouldn't say commonly.
BY MR. GASTEL:
Q     But it was done, correct?
A     It was done on occasion, when the office either requested or was appropriate.
Q     And they and then sales representatives would also occasionally hold dinners where they would pay somebody to come and speak about Exalgo to other invited health care providers, correct?
A     Yeah, there would be a speaker bureau approved by the company, and these were experts that would speak to the PI and utilization of the therapeutic option.
Q     And that was done in Tennessee during the time that you worked at Covidien, right?
A     I don't recall, but what I would say, it was extremely rare.
Q     And in determining how strike that. In determining what prescribers to call on, Sales representatives would target certain types of health care providers, correct?
A     They would not target them. There would be a list of targets that was provided by the organization. ce) Q. And that's what I'm getting at, is that there's a list there's a target list that sales representatives are given, right?
A     Sure. In every pharmaceutical company.
Q     And that's pretty common throughout the industry, right?
A     That's correct.
Q     And that's true for your sales representatives operating in Tennessee while you were at Covidien, right?
A     That's correct.
Q     They would get target lists, and those target lists would be would be based on the people those target lists would be based on the prescribers within that territory who were writing high volumes of opioid prescriptions, right?
MR. BUEKER: Objection.
THE WITNESS: That's incorrect.
BY MR. GASTEL:
Q     Well, then, how were the target lists developed?
A     The target was based on their specialty of what they potentially would provide therapeutic option to a patient.
Q     So are you saying that the term ) "high-volume prescriber" was not part of the target list calculation?
A     I'm not saying that.
Q     Do you know how Mallinckrodt or I'm sorry, Covidien monitored opioid sales in Tennessee during that time period?
MR. BUEKER: Objection.
Vague.
THE WITNESS: I do not.
BY MR. GASTEL:
Q     Does the term "IMS health data" ring a bell to you at all?
A     Yeah, IMS data is provided to all pharma companies.
Q     And that was true for Covidien while you were working there, in June 2011 through February 2013?
A     Yes.
Q     And that's pretty standard across the industry, right, that IMS health data set?
A     I believe so. I don't know if there's other data houses that provide that information, but yes, I think it's fairly common.
Q     And that data would be used in developing the target list, correct?
A     I don't know. I didn't I never created ce) target lists.
Q     When you were the district manager, would you would you direct your your sales representatives to call on the health care providers listed in their target lists?
MR. BUEKER: Objection.
THE WITNESS: Actually I believe the frequency, as well as the weighting of targets in regards to their call list, was provided prescriptively from corporate.
BY MR. GASTEL:
Q     And I understand that. But my my question you were the person who had direct supervision over those sales reps in your territory, right?
A     sure.
Q     And my question is, iS were you directing them to sort of follow that target list that they received from corporate?
MR. BUEKER: Objection.
THE WITNESS: Again, I didn't direct them to do so.
It was provided to them in their training, that they would follow that target list provided them by the company.
So naturally they would follow that, because that's what the ce) company said: "These are your grouping of targets across your entire geography." But it was more than just Exalgo.
They had Pennsaid targets, obviously, which was part of their, you know, portfolio.
BY MR. GASTEL:
Q     Sure. And sales representatives would be trained on the messages that they were supposed to deliver to those people on their target list, right?
A     The brand teams would provide guidance, based on the prescribing information, as to where the therapeutic option would fit with the provider and their portfolio of options, yes.
Q     And sales representatives would be given like these training modules to sort of educate them on the drug, right?
A     Yes.
Q     And then it was the expectation that they would use that training information in their interactions with the physicians, right?
A     Yes.
Q     As the district manager, would you sit in on those training manual training modules?
A     No.
Q     Were you familiar with the types of ce) literature that sales representatives would be delivering to physicians on their target list?
A     Generally, yes. But I never sold anything. So as district managers, we got a general training of what was being used, an "awareness" is what I would call it. But I managed people. I didn't I didn't call on accounts.
Q     Sure. Do you recall being included in e-mail correspondence by some of your sales representatives on the types of sales presentations that they were delivering in the field?
MR. BUEKER: Objection.
Vague.
THE WITNESS: The type of sales what was the last part of that?
BY MR. GASTEL:
Q     Presentations.
A     Sometimes.
Q     Do you recall if Covidien conveyed in its sales presentations that every chronic pain patient suffering from moderate to severe pain can be viewed as a potential candidate for opioid therapy?
A     Every? QO. Yes.
A     No.
Q     Was that something that they shouldn't ce) have been that sales representatives should not have been conveying to prescribers?
MR. BUEKER: Objection.
Assumes a fact not in evidence.
THE WITNESS: Yeah.
I mean, you're asking me to give my advice about something over eight years ago I don't really recall.
BY MR. GASTEL:
Q     I understand that.
A     Yeah.
Q     Well, do you agree that every chronic pain patient suffering from moderate to severe pain can can be viewed as a potential candidate for opioid therapy?
MR. BUEKER: Objection.
Asked and answered.
THE WITNESS: I'm not a provider.
I'm not I don't have a medical degree.
So I think that based on the prescribing information, that's what we shared with physicians for them to make a choice as to whether it was an appropriate patient or not.
BY MR. GASTEL:
Q     Did Mallinckrodt convey in its sales presentations that opioid drugs provided the best ) balance of pain relief and side effects in the treatment of chronic pain?
A     No. Not that I'm aware of.
Q     Was it your understanding when you worked for Covidien that opioid drugs provided the best balance of pain relief and side effects in the treatment of chronic pain?
MR. BUEKER: Objection.
THE WITNESS: Again, I eight years ago, I managed people.
I didn't I didn't sell the therapy.
So I don't recall that.
BY MR. GASTEL:
Q     I understand that you might not recall whether or not that was said or not, but I'm asking if that's your understanding. So is it your understanding that opioid drugs provide the best balance of pain relief and side effects in the treatment of chronic pain?
MR. BUEKER: Objection.
Lack of foundation.
THE WITNESS: Again, I don't recall that.
I didn't sell the therapy personally.
BY MR. GASTEL:
Q     Is that bothering you? Are you okay?
A     I mean, it's a little annoying, to be honest.
MR. GASTEL: Let's maybe can we go off the record and see if we can fix that.
THE VIDEOGRAPHER: The time on the monitor is 9:47 a.m. We are off the record.
(A recess transpired from 9:47 a.m. until 9:53 a.m.)
THE VIDEOGRAPHER: Time on the monitor is 9:53 a.m. We are back on the record.
BY MR. GASTEL: QO. When you were working at Covidien, what was your understanding of the effectiveness of opioids in the treatment of chronic pain?
MR. BUEKER: Objection.
Vague.
Overly broad.
Can we limit it to Exalgo?
BY MR. GASTEL:
Q     Do you need me to repeat the question?
A     No. Based on the the training and the PI that we had, they were effective in in treating pain, based on the pharmacokinetics of Exalgo specifically. I never represented or or was aware of the other therapies acutely.
Q     And then did you expect that your sales representatives who were in the field and operating within your territory that you were assigned to, or ce) over, would deliver that message about the effectiveness of Exalgo in treating chronic pain?
A     They were trained by the organization, based on the prescribing information of Exalgo, to speak directly to the effectiveness of Exalgo with prescribers.
Q     And that's what I'm getting at. And they they were trained and they were expected to deliver the message to physicians that Exalgo was effective in treating chronic pain, right?
MR. BUEKER: Objection.
THE WITNESS: You're using a broad term, such as "the message." They were trained on the prescribing information and to share that information with a provider.
And at that point it's the provider's discretion as to does that fit in their therapeutic option for a patient.
BY MR. GASTEL:
Q     Are you done?
A     IT am.
Q     And part of the prescription information that you're talking about is this idea that Exalgo would be effective in treating chronic pain, right?
A     I think that's in the prescribing information, yes. ) Q. You used the term "prescription information." It was common for sales representatives to leave behind literature for the prescribers that they called upon, right?
MR. BUEKER: Objection.
Assumes a fact not in evidence.
THE WITNESS: I don't recall if they did or did not.
BY MR. GASTEL:
Q     Do you remember having pocket card sets to be used?
A     I don't recall. Again, I didn't sell to the providers personally.
Q     I'm going to hand you a document that we'll marked Exhibit 3.
(Exhibit 3 was marked for identification.)
BY MR. GASTEL:
Q     And if you could be so kind I'm going to give you extra copies, to pass the copies to counsel. Take as much time as you need with that document, sir, but my guestion is going to be, have you ever seen it?
A     I don't recall seeing this. ) Q. Do you see at the top it says "Pain management pocket card set"?
A     What page? The first page?
Q     It's the first page, very very top.
A     Yeah.
Q     You don't recall if iff these were the types of materials that were available to your sales representatives to leave for prescribers that they called upon?
MR. BUEKER: Objection.
Assumes a fact not in evidence.
THE WITNESS: No, I don't recall that.
(Exhibit 4 was marked for identification.)
BY MR. GASTEL:
Q     I hand you a document that we'll mark as Exhibit 4.
A     Is there more than one here?
MR. BUEKER: Yes, there is.
THE WITNESS: I apologize.
BY MR. GASTEL:
Q     Do you see that this is also labeled as a pocket guide from the American Society of Pain Educators? Do you see that?
A     I see it on the front cover, yeah. ) Q. Do you recall ever seeing this in your work with Covidien?
A     I don't. I mean, it's listed as 2010. Tt's 2020. I know I'm getting older, but I don't recall this.
Q     No problem. Will you flip to the second page?
MR. BUEKER: Where it says "For internal use only"?
MR. GASTEL: Yeah.
BY MR. GASTEL:
Q     Do you see at the bottom, on the left-hand column, it says, "Critical to distinguish tolerance, dependence, and pseudoaddiction from addiction." Do you see that?
A     I see it on this document, yes.
Q     Do you recall these terms being used by your sales representatives that tolerance, dependence, and pseudoaddiction?
A     I don't recall that.
Q     Do you recall those terms being used in any of the training manuals that were used to train sales representatives?
A     If the training manual is a prescribing information, I do remember tolerance and dependence. The pseudoaddiction, I don't recall, for...
Q     Do you have any understanding of what the term "pseudoaddiction" refers to?
A     I don't recall that at all.
Q     You can put that document to the side. We're at 5 already? We're flying through these. We're going to be done here in a minute.
(Exhibit 5 was marked for identification.)
MR. BUEKER: You know lawyers say that to get your hopes up.
THE WITNESS: Yeah, I know.
BY MR. GASTEL:
Q     Do you see that on the front cover of this document, it is the it's labeled as the "Exalgo Learning System, Module 3, Focus on Opioids"?
A     I see that on this document.
Q     Do you recall ever seeing this document when you worked at Covidien?
A     I don't recall.
Q     I want you to flip on the at the bottom right-hand corner, you'll see like a number.
A     Uh-huh. QO. Us lawyers, we call those "Bates numbers." Will you flip to the Bates number page MNK-T1 0007855729? So 5729.
A     5729. Okay.
Q     Are you with me?
A     I believe I am.
Q     Do you see in in the paragraph above the header, "Opioid Prescription and Regulation" do you see that?
A     Yes.
Q     So I want to read a little bit
A     5729, right?
Q     5729. So do you see the sentence beginning "Addiction is defined as"? It's the second sentence in that paragraph.
A     Yeah.
Q     I'm going to read that: "Addiction is defined as compulsive use of a drug despite physical harm and overwhelming involvement with its procurement and use. The development of tolerance and physical dependence does not predict the risk of addiction. In fact, while most patients chronically taking opioids for medical reasons develop tolerance and physical dependence, the risk of addiction is low." Did I read that correctly?
A     As it's stated here, yes.
Q     And that comes from this document that's ce) described as the Exalgo learning system, focus on opioids, right?
A     I mean, it's got footnotes. I'm not really sure where it comes from.
Q     Well, what I'm saying is that the the statement that I read is from this training module learning system called "Focus on Opioids."
A     Yes.
Q     Okay. So was your understanding when you worked for Covidien that the risk of addiction is low for those chronically people chronically taking opioids?
MR. BUEKER: According to the doctor's prescription?
MR. GASTEL: You can stop with your I'm I'm asking the questions today.
MR. BUEKER: Okay.
MR. GASTEL: I don't need you to redirect.
MR. BUEKER: Objection to form.
MR. GASTEL: You can just do your objections to form, and I'm going to ask you to stop directing the witness, because that's about the third time you've done that today.
MR. BUEKER: Objection.
Form. 3 BY MR. GASTEL: ce) Q. Do you need me to restate
MR. BUEKER: Trying to get a clear record.
THE WITNESS: Yeah, that would be good.
BY MR. GASTEL:
Q     So was your understanding when you worked for Covidien that the risk of addiction is low for those people chronically taking opioids?
MR. BUEKER: Objection.
Form.
THE WITNESS: It's not for me to speculate.
I'm not a medical provider, so I would just say that we shared the prescribing information with the provider, and it was their choice as to how they prescribed.
BY MR. GASTEL:
Q     You keep using that term "prescribing information," but the prescribing information is the stuff that the sales representatives were trained on to deliver to the doctors, right?
A     No. The prescribing information is a portion of what they shared, but the prescribing information is what the drug is legally approved for utilization by the FDA, the government. And that's what the drug was approved for, and that's what we provided to the providers, to make their choice as to what they thought was best for a particular patient. ce) Q. But in order to sort of educate the sales representatives to go out in the field and talk to medical professionals, they would go through these training modules, right, on the drug?
A     Whatever the training department provided to them, but what they utilize in the field was prescribing information. It gave you everything you needed to know about Exalgo.
Q     So is it is it your understanding that sales representatives didn't take this learning system for Exalgo? I mean...
A     That they did not take it?
Q     Yeah.
A     What do you mean, "take it"?
Q     Well, I think that your testimony earlier was that sales representatives who were under your direction would be trained prior to going in the field in order to sell Exalgo on they would go through these training modules, right?
A     I believe so. I wasn't part of the training department, though.
Q     And you see that the statement that I read, that physical that the risk of addiction is low for those patients chronically taking opioids is in this Exalgo training module, right?
MR. BUEKER: Objection.
Mischaracterizes the document.
Objection.
Form.
THE WITNESS: I think generally it's a portion of this training module, but I don't know in context, I don't know the footnote that's listed there specific to that sentence and where it comes from, looks to me like it's referenced by probably a another organization, if I had to guess.
I don't know.
BY MR. GASTEL:
Q     You can look back, if you're wondering where the citation comes from. There's a bibliography at the end.
A     Are you asking me to do that?
Q     I'm just saying you seem to be caught up on the footnote, and so just to clarify, if you want, for your own sort of understanding, you can
A     I'm not hung up on the footnote. You're asking me to verify something I have no verification of.
Q     Well, I'm just saying that the statement that I read, that the most "While most patients chronically taking opioids for medical reasons develop tolerance and physical dependence, the risk of addiction is low." That sentence is in this ) Exalgo training module, right?
A     It looks like it cites Doyle, Hanks, Calman, from the Oxford Textbook of Palliative Medicine, published by Oxford University.
Q     Sure. That's the footnote. A, That's the footnote. That's the sentence
Q     That's referenced in the sentence that I read?
A     Right.
Q     And all that I'm asking you is the sentence that I read appears in this Exalgo Learning System, Module Three, Focus on Opioids, right?
A     Yeah, cited from that publication.
Q     And you would agree with me that it's important for sales representatives, in order to go interact with doctors, to be trained truthfully and accurately in their Exalgo learning systems and training modules, right?
A     You're asking me if it's important?
Q     Yeah.
A     It's important that they know the prescribing information. I think that this is generally context of the overall pain management potential and and therapies that potentially ) physicians look at.
Q     Okay. When you worked at Covidien, did you have an understanding of whether or not Exalgo was approved by the FDA as an abuse-deterrent opioid?
A     I think it had mechanisms that made it potentially tough to abuse, in my understanding. But again, this is over eight years ago. I didn't sell the therapy personally.
Q     And is that what the sales representatives under your supervision were told to tell doctors?
MR. BUEKER: Objection.
Mischaracterizes his testimony.
Objection.
Lack of foundation.
THE WITNESS: I don't know what they were trained on from the training department in that regard.
BY MR. GASTEL:
Q     Are you aware that the FDA rejected Mallinckrodt's reguest for permission to market Exalgo as abuse deterrent?
A     I'm not aware. I wasn't part of that.
Q     Were you aware that the FDA, in concluding that Exalgo was not approved for abuse deterrent, stated that in terms of abusability, appears to be Similar to OxyContin?
A     I'm not aware of that. ) Q. Are you aware that the FDA, in rejecting that application, said that Exalgo would increase the potential risks for overdose or abuse in those seeking to defeat the extended-release system?
A     I wasn't part of that. I'm not aware of it.
Q     Were you aware that the FDA, in rejecting Exalgo's request for permission to market Exalgo as abuse deterrent, stated that the the FDA predicted that expanded use of Exalgo after marketing raises serious safety concerns and are likely to result in Significant abuse and diversion that further impacts the public health and safety?
MR. BUEKER: Objection.
Form.
THE WITNESS: I'm not trying to be disrespectful, but that is a long statement.
I'm not sure if there was a question in there.
BY MR. GASTEL:
Q     Fair enough. It's probably a bad question. By the way, if I ask a bad question that you don't understand throughout the day, just tell me to rephrase. I have no problem doing that.
A     All right.
Q     And and you're not being offensive. ) That happens to me all the time. Did you know that the FDA stated and predicted that expanded use of Exalgo after marketing raises serious safety concerns and are likely to result in significant abuse and diversion that further impacts the public health and safety?
MR. BUEKER: Objection.
Form.
Objection.
Foundation.
THE WITNESS: No, I wasn't part of any of that discussion.
BY MR. GASTEL: QO. If you were aware of that, would that have changed in any way the work that you did for Covidien as the district manager for your territory?
MR. BUEKER: Objection.
THE WITNESS: You're asking me to speculate on something I wasn't a part of.
BY MR. GASTEL:
Q     I understand. But I'm just saying that if you were aware of those things, do you think that that would have changed any of the things that you did while you were at Covidien?
MR. BUEKER: Objection.
Form.
Objection.
Asked and answered.
THE WITNESS: Yeah, I'm not I'm not ce) here to answer hypotheticals.
BY MR. GASTEL:
Q     Does it bother you at all that that's what the FDA was stating formally, on the record, related to Mallinckrodt's request for permission to market Exalgo as abuse deterrent?
MR. BUEKER: Objection.
Form.
Foundation.
THE WITNESS: I'm not here to give an opinion.
I'm here because I managed people that had that in their portfolio.
BY MR. GASTEL:
Q     Do you believe that pharmaceutical manufacturers like Mallinckrodt or Covidien that manufacture, promote, and sell prescription opioids are responsible at all for the opioid epidemic?
A     I'm not here to give an opinion on that.
Q     So are you refusing to answer the question?
A     No, I'm just not here to speculate on all manufacturers of opioids.
Q     I didn't ask you to. I'm I'm asking you that
A     Maybe I misunderstood. I'm sorry.
Q     Do you believe that pharmaceutical ce) manufacturers like Mallinckrodt or Covidien that manufacture, promote, and sell prescription opioids are responsible for the opioid epidemic?
MR. BUEKER: Objection.
Asked and answered.
That was a objection.
THE WITNESS: I can only speak to Exalgo.
And my representatives were coached to speak to the prescribing information.
If there was things done outside of the prescribing information by a provider, I don't believe Mallinckrodt had responsibility for that.
(Exhibit 6 was marked for identification. )
BY MR. GASTEL:
Q     So this is an e-mail from July 24, 2011. It's an e-mail string. The top e-mail is an e-mail from you to
MR. BUEKER: Can you just give him a minute?
He seems to be reading it.
MR. GASTEL: Sure.
No problem.
THE WITNESS: Okay.
BY MR. GASTEL:
Q     Do you see that it's an e-mail from July 24, 2011, sent by you to a variety of people?
A     Yes.
Q     Those look to be the some sales ce) representatives that were in your territory, and Bill Nichols. Do you see that?
A     I do.
Q     And the e-mail is a little bit of an e-mail string, and the subject is "New Pain Clinic Guidelines bill signed by Tennessee Governor Bill Haslam." Do you see that?
A     Governor Haslam, yes.
Q     I want to read a little bit from the first e-mail in this string, which is an e-mail from Heather Duncan, cc'ing you and Bill Nichols.
A     Uh-huh.
Q     Do you see that?
A     I do.
Q     It says, "Hi, everyone. Great news. As you Know, the state of Tennessee has been plagued for many years with some of the most lenient laws in the country when it comes to the operation of pain clinics. Because of this, we have been flooded with offices operating under the disguise of pain management clinics, while in actuality they are nothing more than pill mills." Did I read that correctly?
A     Looks to be the case.
Q     And then she summarizes a little bit of ce) the bill. But you reply, "Great stuff. Thanks for the news, Heather." Did I read that correctly?
A     That's what the e-mail says.
Q     Was Heather Heather Duncan was your the specialty sales specialist for the Knoxville East territory, right?
A     That sounds correct.
Q     If you were wondering, you'll see if you flip to the next page.
A     Yeah. I saw that.
Q     That's her e-mail signature. She says that she's the specialty sales specialist, Knoxville East territory?
A     Right.
Q     She was sending this to you in July of 2011, and she uses that term that we were discussing earlier about pill mills. Right?
A     That's what she says, yes.
Q     And in fact she says that Tennessee is flooded with pill mills, right?
A     That's her opinion in this e-mail, yes.
Q     So as early as 2011, you were aware that your staff in Tennessee was using this term, "pill mills," to to describe some of the pain management clinics operating in Tennessee, right?
A     I really don't recall that. Again, this is over eight years ago, and if I recall correctly, based on my CV, I was probably on board one month with the company.
Q     And I understand that. But all I'm saying is that based you don't have any reason to believe that this isn't an e-mail that you sent and received, right?
A     No. What I'm saying is [I don't recall this, because it was over eight years ago, and I was on board with Covidien all of one month and had probably had not even been through any training yet myself.
Q     Sure. And so but your sales staff under your supervision was describing pain clinics in Tennessee as pill mills as early as 2011, based on this e-mail, right?
A     I think "supervision" would be loose, being that I've been on board four weeks. Again, this is Heather's opinion in an e-mail.
Q     Do you recall why you said "great stuff" S in response?
A     I think that this district that I was hired to take over had several personnel issues, is the way I would put it. And Heather, as I recall, ) wasn't with the organization much beyond this time frame.
Q     Do you see that she sent this e-mail to Cheryl Herbold?
A     Uh-huh.
Q     I need a verbal response.
A     Yes.
Q     Again, I'm not trying to be rude. It's just the blessed court reporter
A     Yep.
Q     here struggles with the "uh-huhs" and "huh-uh." And then she also sent it to Richard Keen. Do you see that?
A     I do.
Q     Were those two other sales representatives operating in Tennessee at that time?
A     Cheryl, I believe, yes. Richard, I don't know that I ever met. I believe he was gone by the time or in the midst of of leaving the organization as well.
Q     But you don't recall his his assigned territory?
A     You know, I don't. I don't recall.
Q     You mentioned how there was some turnover ce) in regard to the sales reps operating in Tennessee. Was the turnover problem related to the pill mill problem?
MR. BUEKER: Objection.
THE WITNESS: I I have no idea at this point in time.
I believe the majority of those folks that left those geographies self-selected out on their own.
BY MR. GASTEL:
Q     Do you recall anybody telling you why that they were self-selecting in?
A     I don't. That was close to nine years ago.
(Exhibit 7 was marked for identification.)
BY MR. GASTEL:
Q     We're on 7? Take as much time reviewing this document, sir. I'm only going to ask a small question about it. But...
A     Okay.
Q     Do you see that this is e-mail correspondence I think just three days after the e-mail that we just went over
A     Uh-huh.
Q     between you, Bill Nichols, and Heather ce) Duncan?
A     Yeah, it looks like I passed it on to Bill, the regional director.
Q     And you state that that you thought "Heather Duncan did a very nice job here capturing the majority of the town hall meeting from Atlanta." Do you see that?
A     Yeah. It looks to be her her notes and opinion on the meeting.
Q     And then do you recall going to that meeting?
A     I don't.
Q     And then it appears I think it's in your testimony is that she's summarizing this town hall meeting that occurred on July 25th, 2011, right?
A     Yes.
Q     And this was one day after the e-mail that we were just reviewing related to the changes in Tennessee law, right?
A     It looks to be the case, yeah.
Q     So I want to direct your attention to Ms. Duncan's notes from this July 25th, 2011, meeting. You see that there are bullet points. Let's go to bullet point number 9. You with me?
A     Tam. ) Q. I'm going to read it: "Due to the recent changes in Florida laws and clinics shutting down soon, how will Covidien adjust our goals now that the pill mills are shutting down?" Did I read that correctly?
A     That's what's listed here, yes.
Q     And that appears to be some question. And then Heather's notes appear to be, "The answer from Ron." Do you see that?
A     I do.
Q     And she summarizes the answer as the following: "Now that we are having quarterly goals instead of yearly goals, your goals will automatically be adjusted as the changes in the marketplace happen." Did I read that correctly?
A     According to this document, yeah. Yes.
Q     So the marketplace that's being described here includes the market related to those pill mills in Florida, right?
MR. BUEKER: Objection.
Form.
Foundation.
THE WITNESS: I have no idea.
I was on board, again, maybe a month, and I never covered the state of Florida. 3 BY MR. GASTEL:
Q     But once again, we see here Heather Duncan, specialty sales specialist, Knoxville East territory, in July of 2011, using this term "pill mill" in relation to operations, this time it appears in Florida, right?
A     I can't speak for Heather. I mean, her notes show that. But she took these notes. I did not.
Q     And then when you saw these notes, you thought that they did a very nice job of capturing the majority of the town hall meeting from Atlanta, right?
A     Yes, but there's a good portion of it that talks about Pennsaid, and it talks about IMS data that you brought up earlier. Very little about Exalgo. Looks like she was just taking general notes from a town hall.
Q     And are these town halls where sales representatives from across the country get together to talk about what they're seeing in the market for the two drugs that they were marketing?
MR. BUEKER: Objection.
THE WITNESS: I didn't schedule this town hall.
I don't know what the premise of why they held it.
BY MR. GASTEL:
Q     But you would agree with me that there's that that this would be a meeting of sales representatives, right?
A     It looks to be the case, yes.
Q     And were these town halls done ona routine basis, if you recall?
A     In my, you know, year and nine months there, this is probably the only one I recall ever attending. And it was a month on the job.
Q     And but part of the purpose of the town hall would be for the sales representatives to ask questions about what they're seeing in the field, it appears, right?
MR. BUEKER: Objection.
THE WITNESS: That's speculation.
I didn't set this meeting up, so I have no idea what the premise of it was, being a month on the job.
BY MR. GASTEL:
Q     And it certainly appears, based on Heather's notes, that at this town hall meeting, there was this discussion about pill mills in Florida, right?
A     She wrote down a guestion as such. But again, she'd never covered Florida either, in my understanding of her experience with Covidien.
Q     And so do you recall at all this incident of all these Florida clinics being shut down by the DEA?
A     I never covered Florida, so I do not.
Q     Were you aware that there were clinics that were being shut down because of active diversion of opioids?
MR. BUEKER: Objection.
THE WITNESS: I personally am not.
BY MR. GASTEL:
Q     And then how would the closing of these clinics in Florida reguire adjusting the sales goals of Covidien?
MR. BUEKER: Objection.
Lack of foundation.
THE WITNESS: I never set sales goals, nor did I cover the state of Florida.
So I can't answer that.
BY MR. GASTEL:
Q     Well, apparently the response at this meeting in in Atlanta was that sales goals would have to be adjusted because of these clinics being shut down, right? That seemed to be a concern of the ce) sales representatives at this meeting?
MR. BUEKER: Objection.
THE WITNESS: I think you're making assumption.
Again, I never set sales goals, so I don't know what she's inferring to, or even the response.
BY MR. GASTEL:
Q     Well, apparently there was the question, "How will Covidien adjust our goals now that the pill mills are shutting down?" That's the question on this document from Heather Duncan, which you yourself at the time described as a very good or very nice job of capturing the majority of the town hall.
A     Yeah, but you're asking and correct me if I'm wrong you're asking for me to give an opinion on something that's going on in Florida, or goals that I do not set, based on somebody taking general notes from a town hall meeting.
Q     Well, I'm asking you, based on your experience as a district manager, as a district manager, you would have some input in setting the sales goals for your team, right?
A     I have no idea, being a month on the job, if I would or would not at that point in time.
Q     But at some point, that was your ) responsibility, right?
A     Setting goals?
Q     Yeah.
A     No.
Q     Who would be setting the goals for the sales team?
A     That would come down from targeting and and senior leadership. It was basically provided to us.
Q     But you would be aware that your sales team would be given sales targets or sales numbers that they were trying to achieve, either ona quarterly or or yearly basis, right?
A     I was aware that they were given targets.
Q     And sales goals?
A     The sales goals would be a byproduct of those targets and the potential for them to utilize appropriate therapy. But I didn't set those goals either.
Q     So is it your testimony that you don't know why Covidien would need to adjust sales goals based on the pill mills shutting down in Florida?
MR. BUEKER: Objection.
Form.
Objection.
Foundation.
THE WITNESS: Can you restate the ce) question?
BY MR. GASTEL:
Q     So is it your testimony that you don't know why Covidien would need to adjust sales goals based on the pill mills shutting down in Florida?
MR. BUEKER: Same objections.
THE WITNESS: Yeah, I don't not only did I not cover Florida, but I never set sales goals.
So why they would adjust up or down is outside of the scope of what I was asked to do.
MR. GASTEL: Can we go off the record for just one second?
THE VIDEOGRAPHER: Time on the monitor is 10:32 a.m. And you're off the record.
(A recess transpired from 10:32 a.m. until 10:33 a.m.)
THE VIDEOGRAPHER: The time on the monitor is 10:33 a.m. We are back on the record.
(Exhibit 8 was marked for identification.)
THE WITNESS: Just one copy here?
BY MR. GASTEL:
Q     IT think that there's they were just stuck together?
A     No, it's just there's two, unless I'm
Q     Maybe I'm down a copy.
MR. GASTEL: I'm sorry, Counsel.
You're going to have to go with that, Jessica.
I apologize for that.
Just been marked, a document that we'll mark as Exhibit 8.
BY MR. GASTEL:
Q     Take as much time with that document, sir, and I'm going to ask you a couple questions about it.
A     Okay.
Q     So this is e-mail correspondence from January of 2012. Do you see that?
A     I do.
Q     And it's between you and a variety of people, Bill Nichols included, and also Teresa Crawford. Do you see that?
A     I do. QO. And this relates to an announcement from Endo Pharmaceuticals that they were going to have to temporarily shut down production at one of its plants, and that that was going to affect the supply of Opana ER, right?
A     Right.
Q     Do you recall this incident?
A     Vaguely.
Q     And so Opana ER is an opioid, right?
A     I believe so. QO. And then Bill Nichols who I think is your boss at the time, right?
A     Right.
Q     E-mailed or forwards you this story about Endo having to suspend production. And he says, to an e-mail to you and others, "Endo asking docs to refrain from new patient starts for Opana ER." Do you see that?
A     I do.
Q     Okay. And then you respond, sending an e-mail out to what appears to be your entire team at the time?
A     That looks correct.
Q     And that would include a team with coverage of East Tennessee, right?
MR. BUEKER: Objection.
THE WITNESS: It's hard to say.
There's different people than what you referred to earlier.
Looks like the majority of South Carolina, Western North Carolina.
Teresa specifically was in Chattanooga, so a portion, for sure.
BY MR. GASTEL:
Q     Well, you would agree with me that Chattanooga is in East Tennessee, right? Question about Tennessee geography today.
A     Yes.
Q     So you respond back to that team, at least some of them operating in Tennessee, "Team, huge opportunity"?
A     Uh-huh.
Q     "We need to understand who the big Opana ER writers are that are going to be impacted and jump on this opportunity." Did I read that correctly?
A     Yes, I read that.
Q     You go on, "Please examine your top writers and go get this business." Right?
A     Yes.
Q     So I think that you testified earlier that the target lists that were developed had to do with specialties of doctors and not the number of opioid scripts that they were writing, right? Do you recall that testimony?
A     That their targets included some of those, but they also included their entire geography, is what I was referring to. QO. Sure. But here, when we're talking about Opana ER production problems
A     Uh-huh.
Q     you're not directing your sales team to go look at specialties. You direct them specifically to go find the big Opana ER writers. Right?
A     But I don't know who those individuals are. If you can see the top of the e-mail, actually Teresa Crawford states that to me. So vaguely. They need to understand their marketplace, and they would then potentially go talk to those folks that use Opana ER, based on the data provided by the company.
Q     Sure. But you didn't go tell them to go out and just find any Opana ER writer. You specifically used the term "big Opana ER writers." And when you're saying that, you're talking about the people who are writing a lot of Opana ER scripts, right?
MR. BUEKER: Objection.
Form.
THE WITNESS: Based on their examination of their geography.
So as you can see, she provides those providers which she would have had to go and look at or understand within her marketplace.
BY MR. GASTEL: QO. Yeah, I get that. ce) A. Yeah.
Q     But what you were telling her to go do was to go find the big Opana ER writers, which are the people who are writing a lot of Opana ER scripts in her territory, right? A, What I was telling all of the district which is South Carolina, Georgia, Western North Carolina, and a portion of Tennessee was to say examine who are going to be impacted, emphasize who is going to be impacted by the shortage of Opana ER. So it was everybody included equally.
Q     But you don't just say, "Go find any Opana ER writer." You use the term you use is "big." "Big" means they're writing a lot of scripts, right?
MR. BUEKER: Objection.
Form.
BY MR. GASTEL:
Q     It's the number of scripts that is the person that you're directing your sales team to find?
A     I don't think "big" defers to that. It could be somebody that that is an Opana writer, based on however they examine their geography. They know their territory better than I. I never called on these physicians.
Q     So you want this jury to believe your term "big Opana ER writer" did not mean the people who ) were writing the most Opana ER scripts in the territory?
MR. BUEKER: Objection.
Form.
BY MR. GASTEL:
Q     Is that what you're asking the jury to believe today?
A     I'm not speculating on what I'm asking them to believe. I'm telling you what I believed it to be.
Q     Okay. And then Teresa Crawford gets back to you and says, "Top five." Top five. Not any old five.
A     Uh-huh.
Q     The top five. And she lists them out. Right?
A     She does.
Q     And these include writers in Cleveland, Tennessee, right?
A     Right. That she lists.
Q     And you sent this e-mail, directing your sales team to target the big Opana ER writers, after the e-mail where you informed you were informed that Tennessee was plagued by bad laws and flooded with pill mills, right?
MR. BUEKER: Objection to form.
THE WITNESS: That's incorrect.
The earlier e-mail you referenced is an opinion of a representative.
BY MR. GASTEL:
Q     Well, I understand that. I'm not saying that you held that belief. But my question is, you sent this e-mail, directing your staff to target the big Opana ER writers, after you had received the e-mail that Tennessee was plagued by bad laws and flooded with pill mills, right?
A     Your premise is incorrect. Opana ER, if prescribed by the the prescribing information is a correct therapy for pain, as is Exalgo ER, both "ER" standing for "extended release." It has nothing to do with the premise in which you're trying to set.
Q     So you're saying that this e-mail isn't after the e-mail that we looked at back in Exhibit 6?
A     Tf you're asking me chronologically, by date, yes. But the premise that you're saying it's referring to a pill mill, it does not.
Q     So and then you direct the sales team, when they're talking to these big Opana ER writers, to emphasize the positive "the positives of Exalgo with the Tom and Eva case studies and the availability of Exalgo today." Did I read that ce) correctly?
A     Yes.
Q     Do you recall the Tom and Eva case studies?
A     I don't. That would have been approved information that would have gone to the update for approval, though, if it's a case study. It would have been found based on a corresponding PI, that all case studies are provided with, that would be within a prescribing information.
Q     But you you were, at least at the time, aware that these case studies existed, right?
A     I don't recall. I mean, again, this is every bit of, you know, 7, 8 years ago.
Q     But you were directing your sales staff to use that Tom and Eva case study in targeting those big Opana ER writers, right?
A     IT think it's within reason to say that those would have been appropriate for the use of Exalgo.
MR. BUEKER: All right.
So we've been passed a note that Elizabeth Hutton needs to be joined to the deposition.
And she's given us a telephone number.
MR. GASTEL: Let's get off the record.
THE VIDEOGRAPHER: Time on the monitor is 10:44 a.m. You are off the record.
(A recess transpired from 10:44 a.m. until 10:45 a.m.)
THE VIDEOGRAPHER: Time on the monitor is 10:45 a.m. We are back on the record.
MR. GASTEL: I'm sorry.
We we had a small document kerfuffle, Ms. Hutton.
We are we're continuing.
We're on the record.
MS. HUTTON: Thank you.
MR. GASTEL: And for Ms. Hutton's information, since she's not in the room, I just handed the witness Exhibit 9, which carries the Bates label MNK_TNSTA08937924.
(Exhibit 9 was marked for identification.)
BY MR. GASTEL:
Q     Take as much time with this document as you need, sir. I'm going to ask you a couple questions about it.
MR. BUEKER: I'll state for the record that I'm going to try and move the phone, see if that doesn't alleviate the static.
MR. GASTEL: Technology difficulties with the phone.
Let's go off the record.
THE VIDEOGRAPHER: Time on the monitor ce) is 10:47 a.m. We are off the record.
(A recess transpired from 10:47 a.m. until 10:49 a.m.)
THE VIDEOGRAPHER: This is begins Media Number 2 in the deposition of Todd Dean.
The time on the monitor is 10:49 a.m. We are back on the record.
BY MR. GASTEL: QO. You still have Exhibit 9 in front of you, Sir?
A     I do.
Q     Do you see that this is e-mail correspondence between you and a variety of people from January 2012?
A     The only correspondence I have on this document is between me and Teresa Crawford.
Q     Well, you see that it's it's part of a long thread?
A     Oh, there you go. And to the district you're on the second portion. Excuse me.
Q     And this is following up, again, related to that Opana ER shortage
A     Uh-huh.
Q     that we were talking about. Do you see that?
A     I do.
Q     And then Bill Nichols forwards to you this e-mail of January 18th, 2012. Do you see that? Middle of the page, on the first page?
A     I do.
Q     I'm going to read a little bit of that. He starts off, "Great pharmacy call below relative to Opana ER from Amy Painter in Florida. Note that the partnership that Amy is establishing with the pharmacist to meet patient needs. The pharmacist is the person who has to deal face to face with the patient's frustration over not having their meds available. Let's help them better serve their patient customers. Pharmacy calls are critical right now." Did I read that correctly?
A     Yes.
Q     And then you respond back, it appears, by forwarding this message on to your sales team. And it says, “Great example of getting close to your pharmacist and what it can do for your business." Did I read that correctly?
A     Yes.
Q     And you say, “Let's go get this Opana business." Did I read that correctly?
MR. BUEKER: Objection.
Form.
BY MR. GASTEL:
Q     I guess it says "Let's get this Opana business." Did I read that correctly?
A     That's what it states in the e-mail.
Q     And then Teresa Crawford who, again, I think we've established, is a rep operating in Tennessee, right?
A     In Chattanooga, yes.
Q     Responds back to you: "I just left my largest pain office that I had breakfast with last week. Deb Gray, NP, stopped me for more co-pay cards and said since Thursday, they are trying to switch patients from Opana. This is what she told me she was going to do, so let's hope they go through. They normally don't do PAs, but I've already done some, and waiting for response." Did I read that correctly?
A     That's what it says in the e-mail, yes.
Q     Do you know what that "PA" reference is there?
A     I don't.
Q     So here's an e-mail of Teresa Crawford informing you about her largest pain office, right? That's her description of where she just left? Right? ce) A. Based on the shortage of Opana ER, yes.
Q     So and this is just a few days after you directed her to go contact her big Opana ER writers, right?
A     Nine days later, yeah.
Q     And she says that she just left the largest pain office, right?
A     That's what it states in the sentence, yeah.
Q     So that's a reference to how many Opana ER scripts are being written by this
A     No, it's not.
Q     It's not a reference to the number of scripts that are being written by this office, the largest?
A     "Largest pain office" could be number of patients. It doesn't say anything about number of scripts.
Q     Well, you guys don't get information on the number of patients that physicians have. You get number you get information on the number of scripts they're writing?
A     I think
MR. BUEKER: Objection.
THE WITNESS: I would just say, generally, ) you know by volume, when you walk into an office, if they're busy or not.
BY MR. GASTEL:
Q     That's because there's long lines there?
MR. BUEKER: Objection.
THE WITNESS: No. Not necessarily.
BY MR. GASTEL:
Q     So and then she's talking about how she's getting those that largest pain office to Switch over from writing Opana ER scripts, right?
A     She's talking about a conversation she had with a nurse practitioner, which I don't even know in the state of Tennessee that a nurse practitioner can write an opioid.
Q     Okay.
A     But again, this iS nine years eight years ago. I don't I don't recall.
Q     But generally speaking, when your when your reps go into to the offices, especially the largest pain office in their district, they're trying to interact with the people who have prescription power writing authority, right?
A     I think they're trying to gather information, but they're what they're doing is talking about the prescribing information with those ce) who actually can write the therapy. So if she had a general conversation with a Deb Gray, whether she had writing power or not, I can't define at this point in time.
Q     And you had this e-mail correspondence, again, after you were informed that Tennessee was plagued by bad laws and flooded with pill mills, right?
MR. BUEKER: Objection.
THE WITNESS: We had this interaction based on Opana ER, which is an FDA-approved drug.
If used appropriately, appropriate for chronic pain, and Exalgo ER, appropriately, if by the PI is used appropriately, appropriate for use of chronic pain.
BY MR. GASTEL:
Q     But January 2012 is after, in time, September of 2011, right?
A     Goes back to the earlier context. I think you're you're trying to stretch. But chronologically, yes.
Q     And so it's fair to say that you sent this e-mail, and these e-mail exchange occurred, after you were informed that Tennessee was plagued by bad laws and flooded with pill mills, right?
MR. BUEKER: Objection.
Form.
Objection.
Asked and answered.
THE WITNESS: This has nothing to do with pill mills.
This has to do with a shortage of a therapy, appropriately prescribed, with another therapy that potentially is appropriately prescribed to chronic pain patients.
BY MR. GASTEL:
Q     If you don't know what a pill mill is, how do you know if this e-mail is or is not in reference to a pill mill?
MR. BUEKER: Objection.
THE WITNESS: I think "pill mill" is a vague term that's never been defined.
BY MR. GASTEL: QO. You would agree with me that pill mills are where a large number of opioid prescriptions are being written from, right?
MR. BUEKER: Objection.
Vague.
THE WITNESS: I mean, a pill mill could be for any therapeutic drug, generally.
I mean
BY MR. GASTEL:
Q     Are you aware of any pill mill being indicted for writing a bunch of Tylenol prescriptions? ce) A. No, I'm not. I wasn't in that space. I never sold over-the-counter Tylenol, or prescribed Tylenol.
Q     Anybody describe somebody who has a lot of Pennsaid prescriptions as a pill mill?
A     A topical, no.
(Exhibit 10 was marked for identification.)
THE WITNESS: Okay.
BY MR. GASTEL:
Q     Do you see that this is February 2012 e-mail correspondence between you and some members of your sales team?
A     Briefly, yes.
Q     And it begins with this e-mail from Krista Woodworth. Do you see that?
A     I do.
Q     And the subject is "AARP potential is in Tennessee." Did I read that correctly?
A     Yes.
Q     And she e-mails it to you and says, “Todd, good afternoon. As you'll remember from the e-mail I sent out last night, the South Carolina district is ranked number two in the country in terms of Opana ER/Exalgo volume through USC, AARP med D." Did I read that correctly?
A     Yes.
Q     "My natural next question was, which of your specific territories are responsible for most of this volume? Therefore, I did some research this morning and found out that your Tennessee territories carry most of this volume." Did I read that correctly?
A     From her e-mail, yes.
Q     "In light of the difficult managed care environment that exists in Tennessee, this is great news." Did I read that correctly?
A     Yes.
Q     And she attaches this Excel spreadsheet, right?
A     Yeah.
Q     That lists the Opana ER monthly scripts for the territories, right?
A     IT can't verify that. It doesn't yeah, it does say “Opana." Yes.
Q     And then you reply back, "Folks, this is a tremendous opportunity. Please read below and see the corresponding data. Great stuff." One, two, three four exclamation points. "Money is to be had here. TD." Did I read that correctly?
A     Yes. ce) Q. And so this again is after the correspondence that we were just looking at regarding the Opana ER production problems, right?
A     Right.
Q     And then you see that again, your well, let me back up and go back to Krista Woodworth's e-mail. You see that she directs your representatives to the managed care tab and IMS performance analytics for greater detail. Do you see that?
A     No, she encourages me to direct the representatives.
Q     Fair point.
A     I don't recall directing them to look at that tab. QO. So well, you forwarded on to Chris Clark and Teresa Crawford, right?
A     Yes. QO. And Eric Hichman?
A     Yes.
Q     These are the these are the the sales reps in your territory operating in Tennessee at this time, right?
A     That sounds correct. ce) Q. And so and then they're directed to go look either through this e-mail from Krista, or you forwarding it to them, to go look at the IMS performance analytics for greater detail, right?
MR. BUEKER: Can I hear that read back?
I'm sorry.
(Whereupon the Court Reporter read the previous question. )
MR. BUEKER: Objection.
Form.
Objection.
Asked and answered.
BY MR. GASTEL:
Q     You can answer the guestion, sir.
A     I just asked them to read below. What they actually did with it would be up to them to interpret.
Q     Well, you would agree with me that IMS performance analytics data is relates to the number of scripts that doctors are writing, right?
A     Generally, yes, but I mean, it's up to their interpretation as to who they may be able to impact and where a potential shortage of a FDA approved therapy is short, and and to provide providers with another option in case their patients have breakthrough pain.
Q     Well, there's nothing in here about ce) breakthrough pain, right? This is just this is just how you're trying to divvy up your sales representative resources, right?
MR. BUEKER: Objection to the form.
THE WITNESS: No, the whole premise of it is that there's a shortage of Opana ER, which you stated.
What we're saying is that Exalgo ER is another appropriately FDA-approved therapy that is available to the providers.
BY MR. GASTEL: QO. And your response to that, in this e-mail from Krista, is that money is to be made in Tennessee as a result of these opportunities, right?
A     Every pharma company encourages their reps to grow their use of therapy based on reviewing prescribing information with a provider. If there is a shortage of one therapy and ours is available, they're going to grow their business, in theory.
Q     And you sent this e-mail after you were informed that Tennessee was plagued by bad laws and flooded with pill mills, right?
MR. BUEKER: Objection.
Form.
THE WITNESS: Again, you're trying to connect the word "pill mill" to this e-mail.
It's two independent e-mails, with two ) independent content of of information.
BY MR. GASTEL:
Q     But all I'm trying to get is that February 2012 is after September '1l or September of 2011, right?
MR. BUEKER: Objection.
Asked and answered.
THE WITNESS: Your chronological question again, for the last three e-mails, is it's post that question, yes.
(Exhibit 11 was marked for identification.)
THE WITNESS: Okay.
BY MR. GASTEL:
Q     So you see that this is e-mail correspondence from April 2012, right?
A     Yes.
Q     And it's between you and a variety of people, but it begins with this really big e-mail from Mike Patterson to a whole host of individuals. Do you see that?
MR. BUEKER: Objection.
Form.
THE WITNESS: Yes.
BY MR. GASTEL:
Q     You would agree with me that there's a lot of people on this first e-mail from Mike Patterson, right?
A     Yeah.
Q     I mean, we don't need to count them up. We we can agree that there's a lot of people on this e-mail, right?
A     sure.
Q     So and it's directed to the field sales force. Do you see that?
A     Yes.
Q     And you see I want to direct your attention to the one, two the third paragraph down, beginning, "We have received multiple success stories."
A     This is on 194?
Q     Yeah.
A     Okay.
Q     It states, "We have received multiple success stories on how the new messaging has helped move Exalgo up in the treatment algorithm. South Carolina district manager Todd Dean shared the following story highlighting the impact Matt Goddard had with new MSA." Did I see that did I read that correctly?
A     Yes.
Q     What's the new MSA?
A     Master sales aid, is what I recall.
Q     "Matt was able to use the new PK data within the MSA to get into a very meaningful discussion. Specifically they discussed the PK spike with IR hydromorphone 8-milligram contrasted against the strength of Exalgo all the way to the PK profile of 32-milligram, and the justification for once daily dosing with Exalgo. As they went through their discussion and analysis of this data, Dr. T. actually stopped Matt, took the MSA from him, and closely reviewed it in his own hands. He looked at Matt and said, 'This is exactly the dilemma we are in with these chronic pain patients every day. I need to use more Exalgo.'. Dr. T is Matt's number one Opana ER writer target in Charleston. Matt does a great job highlighting that Exalgo is not IR hydromorphone, but rather the efficacy of hydromorphone in an innovative once-daily delivery system. Combining this type of sales message with an appropriate patient type enables you to elevate Exalgo earlier in your customer's treatment algorithm." Did I read all that correctly?
A     Yes.
Q     So what you're describing here is an interaction where Matt, one of your sales representatives, went in and had a successful event with a physician to have him start writing more Exalgo scripts, right?
A     No, I think what Matt did was go in and educate him based on new prescribing information, going from a 16-milligram to a 32-milligram, and with the attached information, it shows you that on page 4 and page 7. But the master sales aid would be developed directly from FDA-approved prescribing information.
Q     Well
A     So when I refer to Slide 4 of the information you provided me today, the OROS technology is a technology that allows the therapeutic effect of the drug to be released over a 24-hour period. When I refer to page 7, it shows you a pharmacologic chart, with the dark line showing that it's released over a 24-hour period. And the reference story that Matt had success with was talking about the lack of a spike with Exalgo, and that it was released over a 24-hour period, appropriately approved by the FDA.
Q     So and you see that there's this ce) reference to the MSA and the doctor looking at it, right?
A     Yes.
Q     And then after the doctor has interacted with the MSA and Matt, he appears to be willing to write more Exalgo scripts, right?
A     I think he's considering a new form of 32-milligram Exalgo, because they have challenges or had challenges, as I recall, with Opana, with breakthrough pain.
Q     But what what Mike Patterson sends to the field sales force, based on this vignette that you've told him
A     Uh-huh.
Q     and he almost is quoting somebody as saying that the doctor said, "I need to use more Exalgo," right? Which suggests, I think, certainly to anybody reading this document, that the doctor is now going to be starting writing more scripts for Exalgo, based on this interaction with Matt, where he's reviewed this MSA, right?
MR. BUEKER: I'll object to the form of the question.
THE WITNESS: No, what he's sharing is that Matt appropriately used the training of the ce) new material, on an extended-release therapy that's FDA-approved, as a potential therapeutic option.
What he's also sharing is that they have and I'll quote in his line, "This is exactly the dilemma that we're in." My understanding would be that they had breakthrough pain, and they're looking for an extended-release therapy that doesn't provide a spike, but gives a therapeutic option to their chronic pain patients, as he references in the second-to-last sentence.
BY MR. GASTEL:
Q     Do you want the jury to believe that the MSA in this vignette that you're describing didn't have an impact on the doctor's understanding of Exalgo?
MR. BUEKER: Objection.
Mischaracterizes his testimony.
THE WITNESS: So there's two things.
Number one, I wasn't part of that interaction
BY MR. GASTEL:
Q     Yeah.
A     -~- with Matt and the doctor. QO. Uh-huh.
A     So it would be speculative for me to ce) answer. And the MSA is strictly not only approved by the FDA, but it's based on the prescribing information approved by the FDA.
Q     And so and I get all that. kLet's in the MSA is that the document that's attached here?
MR. BUEKER: Objection.
Lack of foundation.
THE WITNESS: I don't know if this is an abbreviated MSA or if it's just highlighted portions of the MSA.
I can't speak to that.
Again, this is almost nine years ago.
BY MR. GASTEL:
Q     No problem. So let's flip through this. I want to specifically look at Slide 5.
A     Okay. QO. And we saw earlier this reference to I think it was the Todd and Eva thing that you had in your e-mail. Do you recall that? To using the Todd and Eva let me go back to the... Yeah, if you go back to what I think is 6, when you were directing your sales reps to the use the big Opana ER writers. You used the phrase "emphasize the positives of Exalgo with Tom and Eva case studies," right?
MR. BUEKER: Objection.
Form.
I don't ) think you mean to refer to Exhibit 6.
THE WITNESS: I don't know if that's directly correlated to Exhibit 6 here with this particular piece of information or not.
BY MR. GASTEL:
Q     Well, you don't recall the e-mail that we just looked at that said "emphasizing the positives of Exalgo with Tom and Eva case studies"?
A     Five documents ago, no, I don't recall it. I can pull © back out, if you're asking me to.
Q     Well, is it pull out the January 9th, 2012, e-mail.
MR. BUEKER: I think it's number 8.
THE WITNESS: Okay.
Because 6 is from July 24.
July 24th, excuse me, of ‘ll.
BY MR. GASTEL:
Q     Okay. So whatever January 9th, 2012, is.
MR. BUEKER: For the record, you're looking for Exhibit 8.
THE WITNESS: 8°?
Okay.
And your guestion?
BY MR. GASTEL:
Q     Does that refresh your recollection that you have in the past encouraged your sales representatives to use the Tom and Eva case studies ) in their sales presentations for Exalgo?
A     If they were approved by the brand team, and they were referred to Exalgo utilization, yes. I don't know if that's a direct correlation to the Exhibit 11 you gave to me.
Q     And that's where we're going. So let's look at Slide 5 as part of the attachment in Exhibit 11.
A     Okay.
Q     And it says, bullet point 1, "How Exalgo may help patients like Eva."
A     Okay.
Q     Do you see that?
A     I do.
Q     And then under bullet point 2, there is a reference to the Moore study. Do you see that?
A     I see it referenced here, yes.
Q     And so apparently the Moore study is one of the items that the sales staff should be discussing with patient or with doctors in their Exalgo sales presentations, right?
MR. BUEKER: Objection.
Form.
Objection.
Mischaracterizes the document.
Objection.
Lack of foundation.
THE WITNESS: I don't know that I can ce) answer that.
I did not sell the therapy to the provider.
BY MR. GASTEL:
Q     Well, let's just read the document, then. It says, "But wait, there's more." Right? Number 2. "But wait, there's more. Use the chart from the Moore study to contrast the PK positive files of IR hydromorphone and Exalgo. Steady once-daily dosing provides a consistent release of medication to get Eva through the entire day and night with reduced peaks and troughs." Did I read all that correctly?
A     You did on this document, yes.
Q     So when the document here states "use the chart for Moore study," you don't think that that's a reference that the sales representatives in their Exalgo sales presentations should be using the Moore study to make this point?
MR. BUEKER: Objection.
THE WITNESS: I don't know if they use this in their sales presentations.
If this information would have been approved by the FDA, then it would have been appropriate at that time for them to potentially provide to a provider. 3 BY MR. GASTEL: ) Q. Well, you would agree with me that the document says, "use the chart from the Moore study"?
A     That's what this document says, yeah.
Q     Okay. So let's flip over and
A     Where are we going?
Q     To Number 7.
A     Okay.
Q     Oh, wait, I'm sorry, on 6. And it says, the "Another case for Exalgo, the second patient profile describes Patrick." We saw in Exhibit 8 the reference was to Tom, but here the reference is to Patrick. Do you see that?
A     I see on this it says "The second patient profile describes Patrick." Yes.
Q     Sure. And we see under bullet point 2, "Once again, more on Moore." Did I read that correctly?
A     That's what it says here. QO. And it says here, "You can use the Moore chart to illustrate the steady delivery of medication provided by Exalgo throughout the 24-hour period." Did I read that correctly?
A     Yes.
Q     And so again, this document is directing sales staff under your supervision to use the Moore chart to illustrate the steady delivery of medication provided by Exalgo, right?
A     Not in that context. This is information provided by the brand team as a potential resource, but it would have been submitted to the FDA for approval before they could use it in the marketplace.
Q     And I understand that. And so and then if you go back to the cover of this e-mail, you have this reference to the MSA that apparently was used for at least this one doctor in Charleston in this successful sales presentation that you describe, that then goes out to the entire field sales force, right?
MR. BUEKER: Objection.
Assumes facts not in evidence.
This is not the MSA attached.
THE WITNESS: This is not the MSA attached.
In fact, the document
MR. GASTEL: Counsel, this is the fifth time that you you're
MR. BUEKER: You know what, Ben
MR. GASTEL: It's ridiculous.
You know what you're doing is totally inappropriate.
MR. BUEKER: No, you're asking a totally inappropriate ce) MR. GASTEL: You can clean it up
MR. BUEKER: question.
You're asking a question
MR. GASTEL: You can
MR. BUEKER: Wait a minute, Ben.
MR. GASTEL: clean it up when it's your time to ask this guy questions.
MR. BUEKER: You're asking this
MR. GASTEL: But right now, you are directing this witness, on the record, to give different testimony.
And you need to stop.
And I'm happy to call the judge and get this to stop, if that's
MR. BUEKER: I would be happy to call the judge.
You're you're sitting here asking this witness a question
MR. GASTEL: You make your objections.
MR. BUEKER: that suggests that suggests
MR. GASTEL: You make your objections.
You need to
MR. BUEKER: Ben
MR. GASTEL: stop directing your witness.
MR. BUEKER: I'm going to let you finish, ce) and then you're going to let me finish.
MR. GASTEL: No, I'm not going to let you finish, because this is my deposition, and I get to ask the questions.
If you want to come in and clean something up that you think that I've got wrong, you can do that.
But you're going to stop with your speaking objections.
Stop directing this witness.
Because what came out of your mouth directly came out of this this witness's mouth, and it needs to stop, when it's on the record.
So I'm going to continue to ask my questions.
MR. BUEKER: Ben, are you done?
MR. GASTEL: I'm done.
I'm not
MR. BUEKER: Okay.
Then
MR. GASTEL: letting your your speaking objection is noted.
MR. BUEKER: My
MR. GASTEL: And and you need to stop directing the witness.
MR. BUEKER: All right.
And I'm going to I'm about to tell you, and I'm about to explain the objection. ce) The objection is you asked this witness a question about an MSA in a document that doesn't attach the MSA.
It says on its face that this is the implementation guide.
That is misleading.
I am not going to sit here and let you mislead the witness.
MR. GASTEL: Okay.
Well, your speaking objections need to stop, because they're totally inappropriate, and you're directing this witness on the record to give testimony that you want to give.
MR. BUEKER: I will make a nonmisleading record as I see fit.
BY MR. GASTEL:
Q     So, going back to this e-mail. Okay?
A     Can I answer what you've asked me?
Q     sure.
A     Before we were interrupted on both sides. On this document, number one, it is not the MSA. If you look at the top of every single page, it says "For sales training purposes only. Do not disseminate." So when you say "Do not disseminate," that means do not share with providers. What Matt shared was the MSA, which is not attached to this ce) communication. What this is that you've attached is not to be disseminated. It's for training purposes only.
Q     Sure. Training sales
A     Internally.
Q     Okay. And I get that. Training sales this is the document, is the internal training is the document used to train sales representatives in the field on how to use the MSA, right?
A     No. This is not the MSA. This is a document for training. It's an implementation guide. It is not the MSA, and the guote that was used, that you try to stretch and and connect to Matt Goddard's reference, is the MSA. It says "Matt Goddard had with the new MSA." It doesn't say Matt Goddard had with the implementation guide, which is stated on every single page: "For sales training purposes only. Do not disseminate."
Q     And I understand that. And then the whole the document that's attached to the e-mail is listed as "The Whole Story Sales Aid/Leave Behind Implementation Guide." Right?
A     I'm looking at the document. It says, "Do not disseminate," which means to the representatives, "Do not leave behind. This is for internal use ) only."
Q     Sure. "For sales training purposes only. Do not disseminate."
A     That's right.
Q     So this is for training salespeople, right?
A     It's for their understanding of information, yeah.
Q     Sure. Sure. And so and that's all I'm trying to get at. And and the way that the sales representatives were trained was, according to paragraph 5, to use the chart from the Moore study to contrast the PK profiles of IR hydromorphone and Exalgo, right?
MR. BUEKER: Objection.
Form.
BY MR. GASTEL:
Q     Exact quote.
A     It's understanding. But again, the quote that you're you're referencing to a Matt Goddard, who was in my district, was to a master sales aid, not this material provided.
Q     Sure. And I understand that. And but the the point is, is that the sales representatives, according to this document, in interactions with physicians, are directed to use the ce) Moore chart and study in their interactions with physicians, right?
MR. BUEKER: Objection.
Form.
Objection.
Mischaracterizes the document.
THE WITNESS: The sales training implementation guide is data to consider.
The reference to the quote to Matt Goddard is the MSA.
That's two different documents.
BY MR. GASTEL:
Q     Yeah. And then do you see that there is a at the on paragraph 5, there is a at the very top, there is an image of a woman and some charts. Do you see that?
MR. BUEKER: The witness appears to be looking at the e-mail.
Where are you?
THE WITNESS: I'm looking at the e-mail, your paragraph 5.
BY MR. GASTEL:
Q     I'm sorry. Page 5 of the attachment.
A     Can I ask for clarity? Who who attached the sales implementation guide to this? Was this you, or was this connected to the e-mail?
Q     These are the documents as they've been produced to us.
MR. BUEKER: Object.
THE WITNESS: Yeah, I don't I don't know that that's a correlating document to the e-mail.
BY MR. GASTEL:
Q     Okay. A, I mean the only thing that I see is on page 1, where it says "Pennsaid logo," of any attachment, and another jpeg, MAL Covidien tail jpeg, I don't know that they correspond to the e-mail.
Q     Okay.
A     I don't know. I'm asking for clarity, because I don't I don't know who attached the implementation guide, when the majority of the e-mail talks about a master sales aid, which would have been submitted to the FDA for approval.
Q     And I understand that. So let's just clean up the record here. And I understand. Your testimony is, is that the e-mail relates to the MSA and that the attachment is not the MSA. Get that. No problem. You would agree with me that the attachment, however, is this is for sales training purposes only, related to the "Whole Story Sales Aid/Leave Behind Implementation Guide." Right?
A     My understanding is it says "Do not ) disseminate." And it's for background information, for context.
Q     Okay.
A     But it's separate from the e-mail when it references Matt Goddard about the MSA utilization.
Q     Got it. And then and then let's flip over to, for the thing, for the for the attachment "For sale" that's identified as "For sales training purposes only."
A     Yeah.
Q     "Do not disseminate." You with me?
A     Yeah.
Q     Let's go over to page 5 of that document.
A     Okay.
Q     Now, page 5 has at the very top an image. Do you see that?
A     Of a female?
Q     Yes.
A     Yes.
Q     Okay. And that image, do you know what that image is of?
A     The female? Or the chart?
Q     Well, when when I say "the image," I'm referring to this entire thing right here
(Indicating).
A     Okay.
Q     Okay?
A     All right.
Q     Do you know what that image is from?
A     I'm assuming it's from the implementation guide, for background information.
Q     Okay.
A     And according to this document on page 5, it's trying to establish what would be an appropriate Exalgo patient.
Q     Sure. And it gives this patient profile for this woman that's named Eva?
A     Right. But when it says "Do not disseminate," there's oftentimes where a brand team will come up with information that doesn't get approved for utilization in the field by the FDA. So I can't tell you if this was ever used in the field, other than for background information, for sales training only.
Q     And I understand that. But you would agree with me that the document says that you that it states under paragraph 2 in the Eva study, "Use the chart from the Moore study to contrast the PK profiles of IR hydromorphone and Exalgo." Right?
A     That's what this page 5 says on that ce) particular point.
Q     And so the sales team, according to this document, was being trained to use the Moore study, right?
MR. BUEKER: Objection.
Mischaracterizes the document.
Objection.
Lack of foundation.
Objection.
Form.
THE WITNESS: It says "Do not disseminate" on this article.
This is background information, then.
BY MR. GASTEL:
Q     Okay. Then how were the sales representatives to use the chart for Moore?
A     They weren't, according to this. I don't have an FDA-approved market sales piece in front of me to say, "That's what you should use," that was approved. As far as I know is the document you provided, it says on every single page, "Do not disseminate," which means "Do not share in the public view." I don't have anything in front of me that says, "Here's what was utilized in the field."
Q     Okay. So let's flip over to paragraph 7.
A     Page 7, or paragraph?
Q     I'm sorry, page 7.
A     Page 7? Okay.
Q     It says, "Explain the efficacy of Exalgo. Now iS a good time to remind physicians of the efficacy of Exalgo. The pivotal trial, Hale study, is a great way to do this." Did I read that correctly?
A     Where is that located on the document? I'm sorry.
Q     I'm sorry. Upper left-hand corner, in the gray chart area.
A     Yes. Sorry, I was looking more at the body of it.
Q     No problem. So were sales staff trained to explain the efficacy of Exalgo to doctors?
A     I wouldn't stretch that far. I think they were taking in background sales information. When it says "Do not disseminate," that's a real jump to say what was approved that they ultimately, by the FDA, were allowed to share with a doctor.
Q     Okay.
A     So there's it's a very distinct difference. I mean, it's one thing to get a it's like for me to read a Webster's dictionary, and then what I actually use in the public, that's approved, could be two different things. ) Q. No problem. And then it's the document goes on to say, "Something HCPs may consider when choosing a dose for starting Exalgo." Did I read that correctly?
A     Yes.
Q     And it says, "It may help physicians to know that the median starting dose in the Hale study was 16 milligrams and the median final dose was 32 milligrams." Right? That's what the document says?
A     That's what the document says.
Q     "This may surprise some physicians who start patients on 8 milligrams regardless of the conversion ratio from their previous medication." Did I read that correctly?
A     That's what it says on this document.
Q     "Point out how proper dosing can provide the efficacy physicians are looking for in their opioid-tolerant chronic pain patients." Did I read that correctly?
A     Yes. QO. "T£ it worked for the" "If it worked in the Hale study, it may work for them." Did I read that correctly?
A     Yes. ce) Q. And so were were sales representatives trained to use the Hale study in their sales presentations with doctors?
MR. BUEKER: Objection.
Form.
THE WITNESS: Again, if this was prepared by the brand team for sales training.
I don't know if it ever was utilized, number one.
And number 2, it's in your your whole document that you read on point 2, it uses the words "may consider." And also it states, at the very end, "It may work for them, based on the Hale study." But again, this is a sales training document, not to be disseminated.
BY MR. GASTEL:
Q     All right. Let's go back to the e-mail. So again, from the e-mail from Mike Patterson, directed to the whole field sales force team, he goes on to explain that "Matt does a great job highlighting that Exalgo is not IR hydromorphone, but rather the efficacy of hydromorphone in an innovative once-daily delivery system." Did I read that correctly?
A     That's what it says in Mike's e-mail.
Q     "Combining this type of sales message with ce) an appropriate patient type enables you to elevate Exalgo earlier in your customer's treatment algorithm." Did I read that correctly?
A     Yes.
Q     So it appears, at least here, that the efficacy of hydromorphone is to be used in the sales message, right?
A     No. It's what it says is "the appropriate patient." It's to be potentially considered.
Q     But he but the the way that this is described is that "Matt does a great job highlighting," right? "That Exalgo is not IR hydromorphone, but rather the efficacy of hydromorphone in an innovative once-daily delivery system." So are you trying to convince this jury that the that the efficacy of hydromorphone was not part of the sales presentation that's described here?
MR. BUEKER: Objection.
Mischaracterizes his testimony.
THE WITNESS: This is not my quote.
This is an e-mail from Mike.
So I don't know what you're implying.
What I would say is, again, that it's with an appropriate patient, which would have been appropriate to a PI approved by the FDA.
BY MR. GASTEL:
Q     And appropriate patient are, again, the case profiles that at least you directed back in Exhibit 8 to use the Tom and Eva case studies, right?
A     I don't know at that time if those were FDA-approved materials. It's to consider case profiles. But the information in there, if it was approved by the FDA to use in the field, then I would have said that.
Q     But you wouldn't have directed your sales representatives to use in the field the Tom and Eva case studies if if it wasn't something that they were supposed to be using in the field at that time, right?
A     You haven't provided me with a Tom case study. If Eva is the same Eva that's here, this is for sales training only. And if I would have referenced them to use that in field, that means it would have been approved by the FDA.
Q     Okay. So and then going back to the e-mail correspondence, May 25th, 2012, your response to Mike Patterson's e-mail is: "Oh, yeah, you know it." Right?
A     I don't think my response was to him. My response was to the people that were in our sales training class, which were not all people from my district. These are people so my, "Oh, yeah" was referencing Matt Goddard, who was part of their sales training class, kind of excited, as I recall, that Matt was referenced in in good fun.
Q     Okay.
A     So those are people from all over the country. When you talk about Caitlin Thrower and others, Michele Straw, Ed Ed Wetta, who I believe is from the West Coast, these are just people having fun, talking about their sales class, referencing one of their sales trainees that were in their class with them.
Q     As a positive way to present Exalgo?
A     No. As to say, “Hey, your buddy Matt Goddard got referenced." It was in fun.
Q     In a positive way?
MR. BUEKER: Objection.
THE WITNESS: It was in fun, calling out Matt Goddard to his colleagues in his sales training class. 3 BY MR. GASTEL: ce) Q. Well, do you want this jury to believe that this Matt Goddard vignette was used in this sales force meeting to not encourage other sales folks to do the same thing?
MR. BUEKER: Objection.
THE WITNESS: No. What I would infer from Mike Mike's e-mail would just be that Matt Goddard appropriately used a an approved document by the FDA, which is a master sales aid, for consideration for appropriate patients.
MR. BUEKER: Before we move on, could we take a short comfort break?
MR. GASTEL: sure.
THE VIDEOGRAPHER: Time on the monitor is 11:39 a.m. We're off the record.
(A recess transpired from 11:39 a.m. until 11:48 a.m.)
THE VIDEOGRAPHER: The time is 11:48 a.m. We are back on the record.
BY MR. GASTEL:
Q     Just going back to Exhibit 11 real quick. S A. Yeah.
Q     So I want to direct your attention back to the Mike Patterson e-mail.
A     Okay. ) Q. Below where we were just reading, it states: "To help reinforce." Are you with me?
A     I'm not. What paragraph, or where are you at? Okay, I see it now. Middle of the document.
Q     Okay. It says: "To help reinforce and inspire message strategy and proper use of the new master sales aid and dosing guide, we have attached a few educational tools." And it lists one, two, three four educational tools. Do you see that?
A     Uh-huh. I do.
Q     And one of them listed is the master sales aid implementation guide. Do you see that? AY I see it in his e-mail.
Q     And it says, "This refresher tool reinforces the key inspire message messaging in the new MSA as you continue to master the new message strategy." Did I read that correctly?
A     That's what it says on his e-mail.
Q     And the document that I was walking with you is labeled as the Whole Story Sales Aid/Leave Behind Implementation Guide." And I'll represent to you that according to the way that these documents were produced, this document is attached to this e-mail. So given that, is it fair to say that the ) attachment labeled "Whole Story Sales Aid" is the master sales aid implementation guide as referenced in this e-mail?
MR. BUEKER: I'll object to the form of the question.
THE WITNESS: I would say no.
BY MR. GASTEL:
Q     Okay. All right. You can put that one aside.
(Exhibit 12 was marked for identification.)
BY MR. GASTEL:
Q     Do you see that this is e-mail correspondence of May 3rd, 2012, between Chris Clark
MR. BUEKER: Ben, just give him a minute.
He's still
THE WITNESS: Yeah.
I'm I'm still like halfway through this.
This is hard to read, because it's a run-on paragraph, or more than a paragraph.
Okay.
BY MR. GASTEL:
Q     So do you see how this is e-mail correspondence between Chris Clark and you and Bo Hamilton, dated May 5th or May 3rd, 2012? ) A. I see yeah. I see it's an e-mail from Chris to myself and Bo Hamilton.
Q     Apparently it relates to Advanced Pain Therapeutics of Knoxville?
A     That's in the Subject line, yes.
Q     And it says "Todd" who is Bo Hamilton?
A     He was another representative in East Tennessee.
Q     "Todd and Bo, Passing along a story on the above clinic that is actually in Bo's territory at 900 East Woodland Avenue." Did I read that correctly?
A     That's what it says.
Q     It goes on to discuss this visit that he had at this clinic. And I want to direct your attention to the sentence I know it's hard to read it says, "I knew I had my work cut out." Tt's about halfway down on the right side.
A     You're saying halfway through the the total piece?
Q     Yeah. S A. And "I knew I had my work cut out." Okay. I got it now.
Q     "T knew I had my work cut out but didn't back down, either. He then tells me he made the ce) Opana ER rep cry last week, and she probably wouldn't be back, because he told her that if he didn't provide Lidoderm patches for his patients, he wouldn't consider using Opana ER. He is from Michigan. He throws out how my drug is killing people and confuses it with Palladone on several occasions. But we went through the data, discussed the conversions, answered his questions, and at the end he gets up and tells me that I've been a very honest individual with him and he appreciates that, and then walks towards me and gives me a hug. A bit unnerving, but nonetheless a bound was made in that first call." Did I read that correctly?
MR. BUEKER: Objection.
Form.
THE WITNESS: That's what Chris writes in his e-mail.
BY MR. GASTEL:
Q     Do you know what the reference is, "a bound was made in that first call"?
A     IT have no idea what he means by that.
Q     Is it possibly a typo for "a bond"?
A     I have no idea.
Q     "T know that this physician are not in my system, and I could not even add them as a business ) context because of the ZIP code they are in, but I believe for now I could and can get credit for Diana, and would gradually assist Bo in his office going forward." Did I read that correctly?
A     That's what it says in the e-mail.
Q     So I want to direct your attention to this reference that "my drug is killing people." Did that cause you concern, when a rep of yours reported that a doctor in your territory thought that that the drug was killing people?
MR. BUEKER: Objection.
Form.
Objection.
Mischaracterizes the document.
THE WITNESS: I don't make anything of it.
It's a it's a reference in an e-mail.
I wasn't there, or part of the conversation, so it would be very hard for me to determine what was the context.
And was he talking about Opana?
Was he talking about another therapy?
Was he talking about you know, I I have no idea.
I wasn't there.
BY MR. GASTEL:
Q     Do you know what this reference to Palladone is?
A     I do not.
Q     Do you know why physician a physician ) might be getting Exalgo confused with Palladone?
A     No.
Q     Do you have any reason why Todd Dean thought that that you should become aware of this interaction he had at Advanced Pain Therapeutics?
MR. BUEKER: Can I hear that question read back.
(Whereupon the Court Reporter read the previous question. )
THE WITNESS: I guess I still don't understand the question.
So I'm supposed to think of myself in the third person as to why I thought what?
BY MR. GASTEL:
Q     Well, I guess my guestion I can't imagine that all your sales reps send you a one-paragraph summary of a meeting for every single time that they go out and meet a physician, right?
A     No.
Q     And so I'm wondering, because I imagine that this is not the usual course, where one of your sales reps gives this one-paragraph explanation, if you know why it was done in this instance?
A     I have no idea. It wasn't even his physician, as as he references in the e-mail.
MR. GASTEL: Okay.
Is it 13?
THE COURT REPORTER: Yes, Sir.
(Exhibit 13 was marked for identification.)
BY MR. GASTEL:
Q     Okay. So this is e-mail correspondence from from you to your sales team and Bill Nichols from May of 2012; is that fair?
A     Yes.
Q     And it begins with this vignette from Chris Clark about a "hydrocodone and combo list," right?
A     That's what he references, yes. QO. And it's an e-mail from Chris Clark to you, on May 17th, 2012. And he writes: "Hey, Todd, I wanted to share a hopefully potential success story around the utilization of this hydrocodone and combo list. In digging into it, a lot of the AHA came from some of these family practitioners that were Rxing a lot of hydrocodone in some 60 or so a week of hydrocodone, one particular doc in LaFollette that I have known and called on for a long time." Did I read that correctly?
A     Yes.
Q     Do you know what this reference is to AHA?
A     I don't. ) Q. "Rxing a lot of hydrocodone" means prescribing a lot of hydrocodone, right?
A     I would believe that to be the case, yeah.
Q     So this is a reference to Chris Clark having a successful interaction with a doctor who was prescribing a lot of hydrocodone, right?
A     I think it references that, but I can't define that. I don't have the data in front of me to say whether that's true or not. It's Chris's interpretation thereof.
Q     And so then you pass this along to the rest of the sales team, saying that "This is a great example of putting an Exalgo hit list to work." Do you see that?
A     I do.
Q     And then you provide some thoughts, and one of the thoughts is I'll direct your attention to bulleted item 3 "Our new PK data in our master visual aid totally makes sense to reduce pill count offer true once-daily pain control and efficacy." Did I read that correctly?
A     Yes.
Q     And in fact the term "efficacy" there is all in caps, to provide emphasis, right?
A     I'm not sure if it is or isn't, but it is ce) in caps.
Q     And so is this you directing your sales team to use the master visual aid to emphasize Exalgo's efficacy in treating pain?
A     What it references is the pharmacokinetic data in our master vis aid, which would have been approved by the FDA for use in the field, to show that they can use Exalgo over a period of 24 hours without breakthrough pain, which is the efficacy I reference.
Q     Is the master visual aid different than the master sales aid?
MR. BUEKER: Objection.
THE WITNESS: My understanding would be no, this would be approved material by the FDA for the reps to use in the field.
BY MR. GASTEL:
Q     And I get that. And I'm not asking if it's approved by the FDA or not approved by the FDA. But my question is, is the master visual aid you reference in this e-mail the same as the master sales aid that we were discussing in the previous e-mail?
MR. BUEKER: Objection.
THE WITNESS: I think it's
MR. BUEKER: Lack of foundation.
THE WITNESS: two separate conversations.
If I referred to it here, it would have been approved for them to use in the field by the FDA.
BY MR. GASTEL:
Q     Who told you that these things were approved by the FDA?
MR. BUEKER: Objection.
THE WITNESS: They would not be shipped to us or the representatives for use in the field unless they were approved by the FDA.
BY MR. GASTEL:
Q     How do you know that?
A     Because the brand team has to submit everything to FDA that's used in the general public. Tt can't be a sales aid. It can't be anything not for dissemination. It has to be approved, based on your PI, which is the backbone of every piece of sales information PI and/or corresponding case studies that are approved by the FDA to use in the general public.
Q     And that was your understanding when you were working for Covidien, that the FDA approved these sales documents? ) A. It's my understanding in every pharma company that anything used in the field is approved by the FDA.
Q     Would it surprise you to learn that the FDA does not approve these documents? A, Their promotional arm of the FDA absolutely does approve anything used in the field.
Q     Well, they're submitted to the FDA, but they don't have to be approved, right?
MR. BUEKER: Objection.
Form.
THE WITNESS: No. My understanding is they have to be approved to be utilized in the field.
And it always corresponds to either case study and/or PI that's approved by the FDA for the use of that therapy in any given space.
BY MR. GASTEL:
Q     Would it surprise you to learn that that is not true?
MR. BUEKER: Objection.
Form.
THE WITNESS: Again, it's not for me to speculate on what's surprising.
I'm telling you how we were instructed to use it from the brand teams and the company.
(Exhibit 14 was marked for identification.)
MR. GASTEL: Thank you, Madame Court ce) Reporter. 14?
We're moving right along.
THE WITNESS: Okay.
BY MR. GASTEL:
Q     You see this is e-mail correspondence from May of 2012 between you and your sales team and Bill Nichols, Subject line: "Endo market activity. Be aware."
A     Yes.
Q     It says, "Team solutions" which I think was the the way you describe or how you open the previous e-mail. What is "team solutions"?
A     I think at the national level, they had everybody come up with a district name, and that was put out to the team, to say, "How do you want to be known within internally within the company as to what you do on a daily basis generally?
Q     Got it.
A     So they came up with the name of "team solutions." That wasn't dictated by me.
Q     Okay. And it describes some Endo activity regarding Opana ER. Is that fair to say?
A     According to Chris, in his territory, this is what happened, and that we should have general awareness.
Q     And it sounds like Endo was sort of trying ce) to be hypervigilant during this time period in pushing Opana ER out there. Is that fair to say?
MR. BUEKER: Objection.
Form.
THE WITNESS: Yeah, but what I don't know reference to earlier we talked about earlier today, if this is corresponding to a shortage.
And it references, about halfway through, for lost win back lost business.
My assumption would be that their assumption is that us and the other therapeutics that were in that space, that they may have lost some general business with providers, and that they were wanting to increase their frequency to potentially win some of that back with messaging and activity.
BY MR. GASTEL:
Q     Yeah. So because this is later in the year, after they had those those production problems that we saw?
A     Yeah.
Q     And it looks like this was their attempt, probably, because their production problems were solved, to sort of win back lost business, right?
MR. BUEKER: Objection.
THE WITNESS: Don't know that for sure, but that chronologically makes some sense.
BY MR. GASTEL:
Q     And in fact that's the exact language that you use in paragraph 4 there, is that they are being asked to win back lost business, right?
A     Paragraph 4. On point 4, early and then there's a separate 4, sorry, yeah. But I don't know if that's corresponding to the to the production issue or not.
Q     Sure. And then
A     Could be we have better reps, and they lost business to better
Q     sure.
A     you know, influence.
Q     And you say that because this type of sales marketing works, right? The more you're in the field, the more you're going to sell?
MR. BUEKER: Objection.
THE WITNESS: That is not a direct correlation.
I've had people that are you know, can go see a provider ten times, you know, within a two-day period, and they can see them once in a you know, the person once could could do better.
And there is not a direct correlation to frequency. 3 BY MR. GASTEL: ce) Q. But it's important to have a good sales force if you want to drive the sales?
MR. BUEKER: Objection.
THE WITNESS: Not necessarily.
I've had bad representatives that have done very well because they happen to have a geography that was just doing well.
BY MR. GASTEL:
Q     And so I want to direct your attention to you asked this question, "What do we need to do," and you provide five bullet points. Is that right? AA, Yes.
Q     And bullet point 2 number 2 is "Be aware and hit your key targets with higher frequency to combat their share of voice when appropriate. Keep in mind that only a handful of physicians make all the difference." Did I read that correctly?
A     That's what it says on point 2.
Q     And the concept that a handful of physicians make all the difference, because you have these large prescribers, and if you can get them Switched over, you know, you're going to really boost your sales numbers, right? That's what that means?
MR. BUEKER: I'm going to object to the ce) form of the question.
THE WITNESS: That's actually incorrect.
It could be a handful of physicians that you have a relationship with.
It could be a handful of physicians that utilize your therapy.
Doesn't necessarily mean that they're a high target.
BY MR. GASTEL:
Q     Well, they're a key target, according to the language that's used in this e-mail, right?
A     Everybody on everybody's territory is a key target.
Q     Well, if that were true, why didn't you just say, “Hit your targets"?
A     Because they have to discern what's important within their geography. And not always is it the highest frequency or excuse me, highest count, per se, of a script. It could be somebody so, for instance, you could take a physician from one script to four and have three times the growth. And so that was important to them, to know where they had good growth and relationships. So it could be a key target based on their interpretation of a key target.
Q     Growth being the number of scripts they write? ce) A. Utilization of the therapy appropriately marketed by the the PI and the FDA approved.
Q     But the way that you guys measure growth is scripts, right?
MR. BUEKER: Objection.
Asked and answered.
THE WITNESS: I think it was one metric.
They also had Pennsaid in their in their bag, as well, which is referenced in point 4 of the document.
So this wasn't strictly just on Exalgo.
It was every day that we pull through all that we were charged with to have providers consider our therapies in in their their bag of therapies that potentially could use appropriately.
BY MR. GASTEL:
Q     Well, Pennsaid wouldn't have been affected by this Opana ER push by Endo, right? Pennsaid is not competing with Opana ER?
A     No, but it's in my representatives! bags, and and they represent more than just Exalgo, and they do more than just compete with Opana.
Q     And you said that there are other factors ) that go into growth, other than scripts. What are the other factors?
A     Identifying those who could be a zero. They need to identify their dirt, their territory, to understand where potentially they can get growth at. Is it based on scripts? Yeah, that's a large portion of of growth, but it's not just in key targets. So those who who get the entire book of business is important to them, and you could have a lower quantity provider that's just as important in growth than somebody who doesn't grow at all, that writes a a lot of of a therapy. Does that make sense?
Q     It does, yeah. I'm still a little confused on what other than scripts constitutes growth.
A     I mean, that is the primary driver.
Q     Is there any other driver?
MR. BUEKER: Objection.
Form.
Asked and answered.
THE WITNESS: Yeah, no, I mean, with both therapies, Exalgo and Pennsaid, it's more utilization.
I think that they were also, as part of their yearly evaluation, it could be that they're hitting and doing the things that ce) the company is asking them to do in regards to speaker utilization, as an example.
So there's other things that they do within their day-to-day activity that could impact the job that they're doing when they're evaluated year over year.
It's not just scripts.
MR. GASTEL: 15?
(Exhibit 15 was marked for identification.)
THE WITNESS: Okay.
BY MR. GASTEL:
Q     It's an e-mail from you to your your sales team of September 13th, 2012. Is that fair?
A     Yes.
Q     And it's related to these Quarter 1, fiscal year '13, target information and planning tool. Right?
A     Target list adds in reguest for change or removals.
Q     And you say, "Team, I need everyone to scrub your list thoroughly before you send adds to me. We have already seen errors of targets added, pill mill docs re-added, et cetera. Please, please, please, check your lists. Let me know of anything goofy going on with these." Did I read that ce) correctly?
A     Yes.
Q     So here is where you use the term "pill mill docs." That's your term, right?
A     That's not my term. That's often referenced by other people that bubble that to me, as they would refer to them. I don't own that term.
Q     It looks like your sales reps were trying to add in pill mill docs to their target list for fiscal year '13, right?
A     That's incorrect.
Q     Well, if the e-mail states "We have already seen errors of targets added, pill mill docs re-added?"
A     Right, because this data is pulled from a master data dump, typically from IMS. And what would happen is people would repopulate and in fact, more often than not, our representatives across the country were trying to get folks that may have been abusive in the therapies, potentially to be removed from that list as a distraction, or put into what I would call a parking lot, to not be part of their goaling, or or if they felt uncomfortable going to any particular office, we would tell them not to go. But the target list adds and requests ce) goofy when I refer to "goofy," we literally have had people on target lists, as I recall, that either moved out of the territory, were no longer practicing medicine, could have been in jail, could have died. And so when you have a dead practitioner on your list, that's goofy. So if they know that, and they know their geography, they were they were instructed to scrub that for all the above, to give us that feedback that we could forward back to the data team. But IT didn't scrub lists. I didn't know the providers. This was provided back to Jen Terp, who was in I believe the data analytics you know, data team.
Q     So the reference here to "pill mill docs," which is the reference of how you describe them, what was your understanding of what a pill mill doc was, as you used it in this e-mail?
A     Again, these would be the reps' interpretations that they've bubbled up in the past, that we referenced earlier in the day, like Heather and others that used that term. If she had that term and she wanted to provide me a reason as to why they shouldn't be on a target list to provide to the to the data analytics team, that was something that was ce) bubbled to me. That's a anecdotally, a very broad term, but it was one used more by reps than anybody as to a potential interpretation of abuse.
Q     What were you trying to convey with the term "pill mill docs" in this e-mail?
A     Well, if they were a pill mill doc, as the reps had stated to me, what they were requesting is that we put them in a parking lot, or potentially pull them off their list, so that it they wouldn't even talk to these folks. Exalgo was not generally abused by anybody, because of the pharmacokinetics of the drug. So that wouldn't even be a good target for them to talk to.
MR. GASTEL: Let's take a break.
THE VIDEOGRAPHER: The time on the monitor is 12:21 p.m., and we're off the record.
(A recess transpired from 12:21 p.m. to 12:29 p.m.)
THE VIDEOGRAPHER: This begins Media Number 3 in the deposition of Todd Dean.
The time on the monitor is 12:29 p.m. We are back on the record.
MR. GASTEL: I'm going to hand you a document that we'll mark as Exhibit 16.
(Exhibit 16 was marked for identification.)
MR. GASTEL: And I'm sorry, Counsel, I don't have a copy for you.
MR. BUEKER: All right.
Well, then
MR. GASTEL: You can just
THE WITNESS: You want to look at it first?
MR. BUEKER: We'tll look at it with you.
THE WITNESS: Okay.
BY MR. GASTEL:
Q     Our last exhibit of the day.
A     Oh, wow.
Q     Music to your ears, I'm sure.
A     There you go.
Q     Will you pull back out Exhibit 11?
A     Exhibit ll. What is this exhibit being referenced as, or called?
MR. BUEKER: 16.
THE WITNESS: 16, but I mean, I didn't know what he is referring to it as.
Okay.
BY MR. GASTEL:
Q     Okay. And then flip over to that image on Exhibit 11.
A     Which image?
Q     On page 5 of the attachment. And then ) flip over to page 4 of the document that I just handed you.
MR. BUEKER: Exhibit 16, for the record.
THE WITNESS: Are there page numbers on this?
You said 4?
BY MR. GASTEL:
Q     There's not. I don't think there is. I'm sorry about that.
A     Actually there is, on page looks like 1. But corresponding 2, no page number. 3, no page number. You said it's 3 or 4?
Q     4,
A     Got it.
Q     You with me?
A     Yes, sir.
Q     You would agree with me that page 4 of Exhibit 16 looks exactly like the image on page 5 of the attachment to Exhibit 11, right?
A     They look similar, but I don't know what Exhibit 16 is.
Q     And I understand that. But all I'm trying to get for the record right now, the image on page 5 looks exactly like page 4 of Exhibit 16, right?
MR. BUEKER: Objection.
Form.
THE WITNESS: Yes, so the the image ce) looks similar, but it doesn't have corresponding reference material that's the "Do not disseminate, sales training purposes only." So I really don't know what Exhibit 16 is.
BY MR. GASTEL:
Q     Sure. No problem. And that's what I'm getting to. Does this look like the master sales aid?
A     From nine years ago, I have no idea.
Q     No problem. If I reference to you if I represent to you that Exhibit 16 is the master sales aid, would you have any reason to believe that that's that that's not correct?
MR. BUEKER: I'll object to the form of the question, and lack of foundation.
THE WITNESS: I don't understand your question, because you used a double negative.
Not to believe that it's not?
Is that what you're saying?
BY MR. GASTEL: QO. If I reference -- well, you were at some point familiar with -- with the master sales aid, right?
A     Potentially
MR. BUEKER: Objection.
THE WITNESS: Potentially, at that time, nine years ago, yes, but I can't tell you if this is it.
BY MR. GASTEL:
Q     Well, does it have the characteristics of what would be considered a master sales aid?
A     Actually, no.
Q     Why not?
A     Because typically it was in a hard copy, where they were corresponding page to page, and you would know by the brand team whether it was FDA-approved to be used in the field with a provider. So I can't tell you from this copy what this is.
Q     I get that. So I'm sure the versions that you used were probably a lot more glossy than the copies that were provided?
A     That's not the issue. I have no idea what this document is, if it was approved by the FDA or not.
Q     And so no problem. And so regardless, let's go back to page 4 of Exhibit 16 and to page 5 of the attachment on Exhibit 11. Got both documents in front of you?
A     Page 4 of Exhibit 16.
Q     You've got them. ) A. Okay. So the same ones we're on. I thought you were changing.
Q     No.
A     Okay.
Q     Okay. Images look similar, right?
A     The images do.
Q     Okay. And you would agree with me that Exhibit 11 is for sales training purposes only, not to be disseminated, right?
A     States it all over the document.
Q     States it all over the document. So it's for sales training purposes. And you would agree with me that on Exhibit 11, under the image that looks a whole heck of a lot like page 4 on Exhibit 16, that it directs salespeople to use the chart from Moore, right?
MR. BUEKER: Objection.
THE WITNESS: I disagree.
And not to be technical, but on the page that you provided to me, on every single page, it says "Highly confidential, attorneys' eyes only."
BY MR. GASTEL:
Q     Oh, that's just stuff that us attorneys put on it. You can ignore that.
A     Can I ignore it? It's on the same page. ce) I don't know what this I don't know what this document is.
Q     Well, that was just put there by the lawyers.
A     That was just put there by the lawyers, but it's on the same piece of paper. I have no idea if this is approved to be used in the general public, in front of a provider.
Q     I get it. And then well, and then page 4 says, under the under the two charts that are shown there on the right side you with me?
MR. BUEKER: Page 4 in Exhibit 16?
MR. GASTEL: In Exhibit 16.
MR. BUEKER: Okay.
BY MR. GASTEL: QO. You with me?
A     This is 16?
Q     Yeah.
A     Okay.
Q     It says, "In a lab study conducted in healthy subjects, N equals 11, hydrocodone administration yielded a high plasma level of hydromorphone." Did I read that correctly?
A     In the second column, yes, that's stated on this document.
Q     And then it says, "Less than 10 percent of individuals are poor CYP2D6 metabolizers." Did I read that correctly?
A     That's what it says on this document.
Q     It says, "The contribution of hydromorphone to the clinical effects of hydrocodone is unknown." Did I read that correctly?
A     Yes. It's unknown.
Q     Okay. Very quickly, let's do the same thing for page © of Exhibit 11, the attachment on Ill. You with me?
A     I'm on.
Q     And then on page 5 of Exhibit 16.
A     Yeah.
Q     With me? You would agree that the image on page 6 of Exhibit 11, at the top, looks an awful lot like page 5 of Exhibit 16?
A     It looks similar, other than there's callouts with references on the first exhibit.
Q     And the callouts, you're talking about the numbers 1, 2, 3, 4?
A     That's correct, which is references as to general reference information for training purposes only.
Q     Sure. And then the image of 2 on Exhibit 11 is right next to that chart, right?
A     Yes.
Q     And that chart looks an awful lot like the chart that's in page 5 of Exhibit 16, right?
A     Yeah, they look familiar.
Q     And then if you go to 2
A     Or similar, I should say.
Q     on 6, or page 6 of Exhibit 11, 2 is the "more on Moore" paragraph, right?
A     The callout at the bottom, not the not necessarily the image.
Q     Yeah, yeah. That's what I'm getting at. AY Yeah.
Q     The callout, here. And then and it says, in that "sales training purposes only" document, it says, "Here, you can use the Moore chart to illustrate the study delivery of medication provided by Exalgo." Did I read that correctly?
A     You did.
Q     Okay. So today we've seen some e-mail correspondence where you were encouraging your sales folks to sell Exalgo throughout your territory, which included parts of Tennessee, right?
A     Yes.
Q     And we saw a couple of e-mails that ) reference reference pill mills, and one e-mail that specifically referenced Tennessee being flooded with pill mills, right?
MR. BUEKER: Objection.
THE WITNESS: I recall seeing one by Heather, as to her interpretation.
BY MR. GASTEL:
Q     Sure. So throughout your 21 months working for Covidien in the opioid space, did you ever once contact Mallinckrodt or Covidien's compliance team and inform them that your sales team was reporting to you a flood of pill mill activity in Tennessee?
MR. BUEKER: Objection.
THE WITNESS: Absolutely not.
It's not my word, to use the word "flood."
BY MR. GASTEL:
Q     Did you ever once go to Mallinckrodt and Covidien's compliance team and ask them to examine opioid prescription rates in Tennessee?
A     I think with leadership, we were constantly examining that our representatives were representing Exalgo in the space of opioids to the PI and to the appropriate providers that were not ce) abusing therapies.
Q     Did you ever once go to Mallinckrodt/Covidien compliance team, to report any activity as suspicious and ask them to flag or scrutinize any opioid order as suspicious?
MR. BUEKER: Objection.
THE WITNESS: Not that I can recall, to Exalgo.
BY MR. GASTEL:
Q     Were you aware that Mallinckrodt has a generic business that also manufactured and sold generic opioids?
A     Generally aware, but I wasn't part of that side of the business at all, so I have no idea of their day-to-day business.
Q     If I told you that that side of the business sent 85 million opioid pills into Tennessee, would that surprise you?
MR. BUEKER: Objection.
Form.
Objection.
Foundation.
THE WITNESS: Again, I it's speculation.
I am not part of that business.
I have no idea what they do day to day.
BY MR. GASTEL:
Q     T'm just asking you, would that number ce) shock you?
MR. BUEKER: Objection.
Asked and answered.
THE WITNESS: It's not for me to speculate.
I wasn't part of that business.
BY MR. GASTEL:
Q     Would it cause you concern to learn that they sent 85 million pills into Tennessee?
MR. BUEKER: Same objections.
THE WITNESS: Yeah, again, I wouldn't speculate on what I had no firsthand knowledge of at all.
BY MR. GASTEL:
Q     I promised ten more minutes. I might have gone ll. I appreciate the time today, sir.
A     Thank you.
Q     You're off the hot seat.
MR. BUEKER: Mr. Dean
THE WITNESS: Yes.
MR. BUEKER: not so guickly.
I have a couple of questions.
EXAMINATION
BY MR. BUEKER:
Q     Do you recall being asked earlier today about sales representatives being directed to call on ce) target lists? Do you recall that testimony?
A     Yes.
Q     Did you yourself, sir, ever direct a sales representative to call on a doctor or other prescriber that made that sales representative uncomfortable?
A     Absolutely not.
Q     What was your direction in that regard?
A     If a representative would come back to me, whether it be the environment or they felt like a anybody was doing anything inappropriate from a therapeutic standpoint, or patients, or the situation that they felt harassing, they were instructed not to call on that office.
Q     Okay. And did you ever when you gave that instruction to your sales force, did you ever get any pushback from Mallinckrodt corporate for you telling sales representatives not to call on particular doctors?
A     Absolutely not. If we felt like it was inappropriate, it was my job to advocate on behalf of that representative the reasons why, to my superiors, and they were very open to that, as long as we we could give them context as to why we were asking them not to go to a particular spot for any reason.
MR. BUEKER: Okay.
With that, I have no further questions at this time.
MR. GASTEL: I've got a couple of follow-ups.
I'm sorry.
FURTHER EXAMINATION
BY MR. GASTEL:
Q     How many times do you recall informing Mallinckrodt corporate that your representatives reported back to you something uncomfortable they saw in a sales meeting?
A     Very rarely, but it was acute, if they ever did. And this is for South Carolina, Georgia, Western North Carolina, and Tennessee. It would apply to all within the district. If they ever felt uncomfortable going anywhere, and this would be with any pharma company. If you're not comfortable going into an environment, or you felt like a provider was doing something inappropriately, you are not expected to go there.
Q     Did you ever contact the compliance team about those doctors that were reported to you to flag any prescriptions for them as suspicious?
MR. BUEKER: Objection.
THE WITNESS: No. I did not examine data to that granularity.
That would often be ce) provided, if there was any data that they wanted us to to verify with the representative, but that I didn't know the territories that intimate to to say yes or no.
BY MR. GASTEL:
Q     Was there an established protocol to go to the compliance team and inform them of those problematic prescribers?
MR. BUEKER: Objection.
Form.
THE WITNESS: I don't have a definition for a “problematic provider." If there was a specific acute story, I would bubble that up to my senior leadership to handle as they see appropriate.
BY MR. GASTEL:
Q     Who would have that been?
A     Directly for me, it would have been Bill Nichols.
Q     And would you have expected Bill to then inform the compliance team?
A     I would expect so, but I can't speak for Bill's activities.
Q     How would you have done that? Would you have done that by e-mail correspondence or a phone call? ce) A. E-mail and/or phone, depending on you know. But again, it was it was fairly rare. So I I wouldn't say it was a daily activity, by any means.
Q     Would it surprise you to learn that we didn't find any e-mails between you and Bill Nichols where you were reporting a report from one of your sales representatives of a problematic prescriber? We didn't find a single e-mail like that.
MR. BUEKER: Objection.
Form.
Foundation.
THE WITNESS: It's not for me to speculate whether you were surprised or not.
BY MR. GASTEL:
Q     Well, I'm asking you if if you would be surprised that we didn't find any such e-mail.
MR. BUEKER: Same objections.
THE WITNESS: It's not for me to speculate whether I was surprised or not.
BY MR. GASTEL:
Q     You said that this happened very rarely. Can you guantify, one time, two times, three times?
A     I can't recall, from nine years ago. It was rare.
Q     That's it for me.
A     Thanks.
MR. BUEKER: Hold on one second.
Elizabeth, do you have any questions?
MS. HUTTON: JI do not.
MR. BUEKER: Okay.
That concludes the deposition.
Thank you, Mr. Dean.
THE WITNESS: Thank you.
THE VIDEOGRAPHER: This concludes the videotaped deposition of Todd Dean.
Total number of media used is 3.
The time on the monitor is 12:46 p.m. We are off the record.
(The deposition was concluded at 12:46 p.m.)