This deposition is of Sanjay Panda, an executive with ALZA. During this Duragesic lawsuit, Panda testified as to how the Duragesic fentanyl patch is manufactured at the Vacaville Duragesic factory. I believe I’ve already posted this in PDF format, but here it is in text format.
THE VIDEOGRAPHER: Good morning. My name is Michael Barber, and I am a videographer associated with Barkley Court Reporters located at 222 Front Street, Suite 600, San Francisco, California, 94111.
The date is October 23rd, 2006. The time is 9:21 a.m.
This deposition is taking place at the Barkley Court Reporters office at 1435 River Park Drive, Suite 502, Sacramento, California 95815, in the matter of Judith Davis versus Johnson & Johnson, et al., Case No. 505 CV 2910C10 GRJ.
This is the videotape deposition of Sanjay Panda being taken on behalf of the plaintiff.
Counsel, would you please identify yourselves for the record and state whom you represent.
MR. ANGWIN: Ed Angwin for the plaintiffs.
MR. HARVEY: Todd Harvey for plaintiffs.
MR. ZELLERS: Michael Zellers for the defendants.
THE VIDEOGRAPHER: Thank you. Would the court reporter please swear in the witness.
(Whereupon, the witness was sworn.)
MR. ZELLERS: Mr. Angwin, before we start, I would like to note that this deposition is considered by the defendants as being confidential and subject to the protective order.
We also have agreed that this deposition is being taken in a number of cases which the court reporter will note in the transcript.
One last thing: All objections except as to form are reserved.
MR. ANGWIN: Thank you. And we understand and we will be using certain documents which have been produced subject to the protective order, and we will treat them accordingly.
Also, for the sake of not having to depose Mr. Panda five times, we are taking this in the case of Debra Evans, Dorothy Hart, Lee Hendelson, and Joseph Pinedo, and the court reporter is going to designate those in the record.
EXAMINATION
BY MR. ANGWIN:
Q. Mr. Panda, I understand you have been deposed before; is that correct?
A. That's true.
Q. You are familiar with the process?
A. True.
Q. Okay. You understand I am going to ask you a series of questions. If you can answer them, answer them. I don't want you to guess. I don't want you to state things unless you know them. And also if you have — if you feel a question I ask Is unclear, you are welcome to ask me to rephrase it or else you are welcome to take a break whenever you want to or confer with your counsel.
A. Thank you.
Q. Can you please state your full name for the record.
A. Sanjay Panda.
Q. Mr. Panda. And, Mr. Panda, where do you 09:23A reside?
A. Sacramento.
Q. Sacramento, California?
A. North of Sacramento. Yuba City.
Q. Where are you currently employed?
A. Alza Corporation.
Q. In what city is that in?
A. Vacaville, California.
Q. Okay. Did you review any documents or other materials in preparation for this deposition?
A. No. I was traveling. I did not get time.
Q. It's my understanding you have been deposed previously.
A. Yes.
Q. Did you review documents prior to those depositions?
A. Yes.
Q. And I believe you testified as to what those were. Since those depositions and this deposition, have you reviewed any documents which relate to the 2003/2004 time frame or any of the lots that are involved in the five cases we are here about today?
A. No.
Q. Have you also given trial testimony in any cases relating to Duragesic patches?
A. No.
Q. Have you given testimony by affidavit or sworn statement in any cases involving Duragesic patches?
A. No.
Q. When you previously testified, which cases was that in?
A. I don't recall the cases. I think — believe one was Thompson case, but I don't recall.
Q. That was the Thompson case, the Texas case?
A. (Witness nods head).
Q. Would that be the one where Fletch Tramble (phonetic) deposed you? Does that sound familiar?
MR. ZELLERS: If you know.
THE WITNESS: I don't know.
BY MR. ANGWIN:
Q. Were you also deposed by Clay Robins In the case?
A. I'm not good with names, I don't know.
Q. Have you been deposed twice?
A. Twice.
Q. Those were both involving cases where a Fentanyl patch was alleged to have caused a death?
A. Yes.
Q. Okay. Those are the only two?
A. Only two.
Q. In either of those depositions, were you put forward as what is called a corporate representative?
MR. ZELLERS: Speculation, foundation. Objection.
THE WITNESS: What do you mean by corporate?
BY MR. ANGWIN:
Q. There — did you review a deposition notice in either one of those cases?
A. Yes.
Q. And the deposition notice, did you note that there were certain areas of testimony which were designated.
A. Yes.
Q. And did you understand that in certain of those areas, you were testifying about the areas that were designated?
A. Yes.
Q. Okay. Generally, would you categorize those areas for me.
MR. ZELLERS: Objection. The deposition notices in those other cases will speak for themselves and be far more precise than this witness's recollection.
MR. ANGWIN: I'm glad to rephrase.
MR. ZELLERS: Or he can answer to the extent he is able to.
THE WITNESS: Manufacturing and QA.
BY MR. ANGWIN:
Q. Is QA quality assurance?
A. Yes.
Q. Those are the two areas you are most knowledgeable about?
A. Yes.
Q. In the 2003/2004 time frame for Alza employees, would you be the person most knowledgeable about those areas?
MR. ZELLERS: Objection. Vague and ambiguous. Overbroad. Speculation.
BY MR. ANGWIN:
Q. And the two areas I'm talking about are manufacturing and quality assurance with relation to — let me clarify that.
A. Sure.
Q. With relation to the Duragesic patch, would you be the person in the 200312004 time frame who would have the most knowledge about the manufacturing process?
A. 2003, no. 2004 yes.
Q. Okay.
MR ZELLERS: Let me just make a note for the record that the witness is not being produced here today as a corporate representative on those subjects. Of course you are free to inquire as to his knowledge on either.
BY MR. ANGWIN:
Q. What about quality assurance in 200312004 time frame with relationship to the Duragesic patch?
A. No, I would not be.
Q. Who would be?
A. I cannot state a name.
Q. Okay. Can you tell me your educational background, just college.
A. Master's in environmental chemistry from Ravi Shanker University, R-A-V-I, S-H-A-N-K-E-R. Master's in analytical chemistry.
Q. Which institution was that from?
A. University of Mississippi.
Q. Okay.
A. And business — master's in business administration from St. Mary's, California.
Q. With regard to the environmental chemistry and analytical chemistry degrees, are you a member of any professional chemistry organizations?
A. Used to be but not anymore.
Q. Okay. And are you — do you currently — have you taken any courses in the past, say, five years to keep up with any current developments In the areas of environmental or analytical chemistry?
A. No.
Q. Is that an area that you focus on now In your work with Alza?
A. No. It's general management.
Q. General management?
A. Yes.
Q. Would that be management of the manufacturing area?
A. Yes.
Q. Can you — is there a difference in your — the way you use the terms manufacturing and production?
A. No, they would be the same.
Q. If I use the terms interchangeably, would that be acceptable?
A. That would be okay.
Q. When we use the terms manufacturing and production with relation to the Duragesic patch, are we talking about the manner in which the patch is created and then ultimately up to the time it's shipped out?
A. Yes.
Q. And that would include everything from I assume formulation of the drug on up to final shipping?
MR ZELLERS: Objection. Vague and ambiguous. Overbroad.
THE WITNESS: Management from my perspective would be managing personnel, material, not per se the chemistry of formulation.
BY MR. ANGWIN:
Q. When you managed the personnel in the materials, would that be an all aspects of the manufacturing line?
A. I don't understand the question actually.
Q. For example, if there were — do you have responsibility from 2004 time frame forward with regard the Duragesic? Did you have responsibility for any areas dealing with the materials that were used In formulating the gel that is used in the patch?
A. I would have responsibility of the unit that would do that.
Q. Okay. I'm trying to figure out if you were focused on all areas of the production line or more focused on one area in your work from 2004 forward with regard —
A. For Duragesic, it would be all areas.
Q. Okay. All right.
Tell me about your professional background, which I know you have been deposed on it earlier, but just generally, what companies did you work for before you worked for Alza?
A. Before I worked for Alza, I worked for Airtoxics, which is an environmental company.
Q. Can you spell that, please.
A. A-I-R-T-O-X-I-C-S. T-O-X-I-C-S. Worked for a company CalGene owned by Monsanto, which is a ag/biotech company.
Q. Ag for agriculture?
A. Yeah, or food biotech, whatever way you want to say.
Q. Is that engineered food products?
A. Yes.
Q. All right What did you do at Airtoxics?
A. Airtoxics, I was instrumentation specialist.
Q. Okay. What products did they produce?
A. They did not produce any product. They were a environmental testing lab.
Q. Okay. And did you actually perform tests on machines while you worked for Airtoxics?
A. Yes.
Q. Okay. What type of products or other things did you test?
A. At Airtoxics?
Q. Yes, I'm sorry, Airtoxics.
A. Airtoxics would be air, water, and soil samples.
Q. This would be, I guess, using your environmental chemistry degree?
A. Yes.
Q. Okay.
A. Chemistry in general doesn't have to be environmental chemistry.
Q. What about at CalGene, what products did they produce or were you involved with?
A. CalGene is a food biotech company so they would deal with seeds, corn, maze, all different sort of seed products.
Q. Would some of these by genetically engineered food products?
A. Mostly it would be genetically engineered.
Q. What was your actual job duties for that?
A. R&D chemist.
Q. Research and development?
A. Yes.
Q. Okay. And when you worked at either of those companies or any other company prior to Alza, did you work with any type of machinery that was similar to the machinery that is used to manufacture the Duragesic patch?
A. No.
Q. When I say that, I'm talking about form-filled CO machines or for the other patches would be matrix patches that produce a matrix.
MR. ZELLERS: Objection. Vague and ambiguous. Overbroad. Go ahead.
THE WITNESS: No.
BY MR. ANGWIN:
Q. When did you first come to work for Alza?
A. 2002.
Q. There are also entities involved in this case. Have you worked for any other entity that's affiliated with Alza?
A. I don't understand the word entity. What do you mean?
Q. There are other companies. For example, Janssen Pharmaceuticals?
A. No.
Q. Johnson & Johnson?
A. No.
Q. Okay. Let me, so I don't have to go through all of them, have you worked for any other company other than Alza with respect to making the Duragesic patch?
A. No.
Q. When did you first come to work for Alza?
A. 2002.
Q. What was your job when you came to work for Alza?
A. Quality assurance associate.
Q. What were your job duties as a quality assurance associate?
A. My job duties were to investigate any nonconformances related to Oros.
Q. Relation to what?
A. Oros, O-R-O-S, which is a tablet, not the patch, but the tablet side of the business.
Q. Am I correct that at the Alza facility, there were a number of pharmaceutical products that are manufactured and have been manufactured during the time you worked there?
A. Yes.
Q. And I know you have been involved with several of those, and I am going to go through those, but at the time you were hired, you were working with the Oros patch?
A. Yes.
Q. I'm sorry, Oros tablets?
A. Oros tablet.
Q. What is the active ingredient in Oros?
A. There are several different tablets. It would depend on which tablets you are talking about. One example would be methylphenidate.
MR. ZELLERS: Off the record for just a second.
MR. ANGWIN: I'm not going to go into that.
MR. ZELLERS: Just for your information, Ores is — you got transdermal and you have got Oros, so it's just another side of the business. There is a lot of different pills —
MR. ANGWIN: Okay. Thank you.
MR. ZELLERS: — that make up Oros.
MR. HARVEY: We're not interested — we're just trying to get background.
MR. ZELLERS: I understand. I was just trying to speed it along.
(Whereupon, a brief discussion off the record.)
MR. ANGWIN: Thank you. Mr. Zellers, for clarifying that.
Q. Am I correct the Oros would be a — Oros refers to tablet forms of certain pharmaceuticals?
A. Yes.
Q. Are those made on machines?
A. Yes.
Q. And how long did you work as a quality associate in the Oros division?
A. Almost a year.
Q. Okay. Can you briefly go over the training you received before you began working on the Oros production side?
A. It's not production. It's quality assurance side.
Q. I'm sorry. Quality assurance.
A. Review all the quality procedures.
Q. Let me stop you right there. Would that be some written materials?
A. Yes.
Q. Okay. Would those be — what written materials would those be?
A. As a quality associate for Oros tablet side of the business and because you are investigating, you would have to review not only QA documents but production documents to understand then the manufacturing process to investigate it.
Q. Would that include documents such as standard operating procedures?
A. Yes.
Q. And if I refer to those, can I refer to those as SOPs?
A. SOPs.
Q. Okay. I interrupted you earlier. Other than those documents, the documents you were referring to, what other training did you have before you began to work as a quality associate?
A. All corporate documents related to manufacturing. All safety documents related to manufacturing. Extensive training by the process engineering department related to Oros manufacturing.
Q. Okay. Is that sort of on-the-job training? Would that be a good way to characterize the last training you spoke of?
A. Sure.
Q. So am I correct there was some written documentation and then there was also on-the-job training?
A. Uh-huh.
Q. How much written documentation was there that you reviewed how long did it take you to review that, a day, a week?
A. Couldn't quantify.
Q. Okay.
A. But long time.
Q. Okay. And the on-the-job training, was that where you would work another person who was familiar with the process?
A. Yes.
Q. Okay. And they would basically take you and show you the job duties and what you were supposed to do?
A. Yes.
Q. How long did the on-the-job training last?
A. Couldn't quantify.
Q. Did it last less than the year you worked there?
A. It would be at least three months.
Q. Okay. Would I be correct that the process you spoke of where you review written documents and then have on-the-job training is generally the process that is used and has been used at Alza to train persons who come to work there?
MR. ZELLERS: Objection. Vague and ambiguous. Overbroad.
THE WITNESS: It's too general a question. It would depend on what your job is.
BY MR. ANGWIN:
Q. Someone involved in the manufacturing or production.
A. It would be much longer than that.
Q. Okay. But that's generally the type of process they would go through?
MR. ZELLERS: Same objection.
BY MR. ANGWIN:
Q. Would be they review certain documents and have on-the-job training?
MR. ZELLERS: Same objection.
THE WITNESS: Like I said, yes and no. It depends on — if you ask for a specific category I would answer that, but it's too general a question.
BY MR. ANGWIN:
Q. We'll go into that later. Thank you.
A. Okay.
Q. After you worked as a quality associate on the Oros side for almost a year, did you change job?
A. Yes.
Q. Did you get promoted?
A. Yes
Q. What did you get promoted to?
A. Production manager transdermal operations.
Q. When was that?
A. 2003.
Q. What were your job duties as the production manager for transdermal operations?
A. Job duties were to ensure that all logistics were in place for the manufacturing of transdermal products.
Q. Is there a written document which sets out the job duties for the production manager of the transdermal operations?
A. There is job duties listed for production manager, not specifically for transdermal operations.
Q. Where would those be listed?
A. In the HR documents.
Q. Human resources?
A. Yes.
Q. Okay. What training — let me back up on that.
Was there a person who preceded you as the production manager for transdermal operations? Did someone have that job before you did?
A. Yes.
Q. Who was that?
A. Jamie Dessel.
Q. Can you spell that, please.
A. J-A-M-I-E, D-E-S-S-E-L.
Q. Okay. And did Jamie Dessel move to another position after you became the new manager?
A. Before I became the new manager.
Q. Was that a position within Alza or outside the company?
A. Within Alza.
Q. Where did Jamie move to?
A. Planning department.
Q. Okay. Was that a promotion?
A. I don't know.
Q. Okay. How were you trained to be the production manager for the transdermal operations?
A. Trained in finance, operations, QA, logistics, all aspects of how to run the business by different people in the company.
Q. As part of your training for the transdermal, did you actually view the transdermal production lines?
A. Yes.
Q. Okay. Have you been trained on how on operate any of the machinery that is involved from the 2004-forward time frame on the transdermal lines?
A. No.
Q. As we sit here today, could you go operate those machines?
A. No.
Q. Have you been trained in any of the job duties that a production worker would have on the transdermal lines?
A. No.
Q. Okay. Could you perform any of those job functions today?
A. No.
Q. Okay. Who trained you when you became production manager? Was there one person or more than one person that trained you?
A. Many, many people.
Q. Okay. With regard to areas involving production, I'm not talking about finance or any of those kind of things. We're talking production which is also you said manufacturing.
A. Sure.
Q. With regard to those areas, was there a primary person who trained you?
A. Primary person would be Jamie Dessel. Primary person would be Paul Shrock. There would be numerous others.
Q. Can you spell Shrock, please.
A. S-H-R-O-C-K.
Q. What was Paul Shrock — what was Paul Shrock's title at the time that he was involved in training you?
A. Production manager.
Q. Okay. And the training you had, was that on all transdermal products that were manufactured by Alza in the 2004 time frame?
A. In general, yes.
Q. Can you go through — as you sit here today, do you recall what those products were?
A. Yes.
Q. Can you list them briefly?
A. Nicoderm.
Q. Okay.
A. Catapres.
Q. That's C-A-T-A-P-R-E-S?
A. Mm-hmm. Scop.
Q. That's S-C-O-P. Is that short for Scopolamine?
A. Yes. Testoderm.
Q. Testoderm. Is that testosterone?
A. Yes.
Q. And Duragesic?
A. And Duragesic.
Q. And that is the Fentanyl patch?
A. Yes.
Q. Okay. The Nicoderm patch, does that — is that a matrix patch or a reservoir?
A. Matrix.
Q. Before I go into that, do you understand the difference between a matrix patch and reservoir patch?
A. Yes.
Q. Can you explain that briefly to me?
A. Yes. A matrix patch is made where the drug is laid like a film on a — a layer on a film, and the reservoir patch is when a blob of a gel or the drug is in between two layers of film, just pressed together.
Q. Okay. I'll go into that a little more in detail, but you said the Nicoderm was the matrix patch. Is the Catapres a matrix patch or a reservoir?
A. Everything else but Duragesic is a matrix patch.
Q. So Catapres, Scop or scop, and Testoderm are all matrix patches?
A. Yes.
Q. Here we are talking about — I was asking you about the 2004 time frame.
A. Uh-huh.
Q. Are there different or are there any more transdermal products manufactured at the Alza plant today other than the five you listed?
A. No.
Q. Have any of — are those products still manufactured there?
A. Testoderm is no longer manufactured.
Q. Okay. But the other four are?
A. Yes.
Q. Okay. Although I have some general questions about it, I want to really focus today upon the production of the Duragesic patch.
A. Okay.
Q. And am I correct that your knowledge on that would — let me back up. When would your knowledge about the production and manufacturing of the Duragesic patch begin?
A. Q3 of 2003.
Q. That's the third quarter of 2003?
A. Yes.
Q. When does that begin?
A. August/September time frame — August approximately.
Q. Okay. Is that when you took over as production manager or before?
A. No. I was production manager in 2002.
Q. Okay. I'm sorry.
A. Beginning of 2002, so..
Q. All right All right.
A. Beginning of 2003, not 2002. Sorry. Beginning of 2003.
Q. Okay. And then, from the beginning of 2003 through approximately August of 2003, were you being trained in various aspects of the job of production manager?
A. Yes.
Q. When you did you actually fully take over that position?
A. That would be on-the-job training, so when you start, you take over.
Q. Okay. So from day one you were in charge?
A. Yes.
Q. Okay. I'm going to show you a document that we have — been produced which has been marked as DUR 0029463 which also has the following page, 29464. I'll give you a copy of that.
Look at that for a moment I have some questions about that.
(Whereupon, Exhibit 1 was marked for identification.)
THE WITNESS: Okay.
BY MR. ANGWIN:
Q. I believe there is a second page to that, sir.
A. Oh, sorry.
Q. I'm not sure there is anything on it, but have you seen that document before or a document like that?
A. Yes.
Q. What does this document represent?
A. The document represents the production series for Duragesic.
Q. When you say production series —
A. The different steps that involved in making from raw material to a final product.
Q. Those are all basically generally discussed on this page?
A. Yes.
Q. Okay. And was this the same — does this represent how the production was done in the 2003 through 2004 time frame?
A. Yes.
Q. Is this the same as the production that's done today for the Duragesic patch?
A. Yes.
Q. Okay. And going through this generally, there is a mixing process. Is that where the Fentanyl gel is created?
A. Yes.
Q. When I say Fentanyl gel, I am referring to the gel that's inside. Is that a proper way you refer to the gel that's inside the patch?
A. Fentanyl gel, yes.
Q. What is that made of?
A. Alcohol, water, Fentanyl, HEC.
Q. I'm sorry, what was the last one?
A. Hydroxyethyl cellulose.
Q. Cellulose, okay. What is hydroxyethyl cellulose?
A. I couldn't comment.
Q. Are you a chemist?
A. Yes.
Q. Okay. Can you tell me anything about that?
A. It is a polymer.
Q. Is that an inert material or an active ingredient in the patch?
A. It's inert material in the patch.
Q. Okay. The alcohol, it says 95 percent USP. Can you tell me what that means?
A. United States pharmacopeia. It's alcohol that is 95 percent pure.
Q. The next thing, Fentanyl base, can you tell me what that means?
A. That is the drug. That's the API active ingredient.
Q. What does the term base mean?
A. Not acid but base.
Q. Okay. And then purified water. I'm assuming that's just water.
A. Yes.
Q. Okay. When the Fentanyl is put into the mixing, is it basically in a powder form?
A. It's in a powder form.
Q. Once It's mixed with the other ingredients, does it become a gel form?
A. Yes.
Q. And then, the next —
A. I'm sorry. I shouldn't say — it becomes a gel form, but it's one of the ingredients in the gel.
Q. Thank you for clarifying that.
Under that it says drug reservoir gel. Is that what we just discussed, that when they are mixed together, they are the Fentanyl gel?
A. Yes.
Q. Okay. Next one it says: Form-filled seal operation. Is that also referred to as FFS?
A. Yes.
Q. Okay. What does that entail?
A. Form-filled seal is when you take two different layers of films, put drug in the middle, seal the two layers, and that's your form-filled seal.
Q. Is there a machine involved in that process?
A. Yes.
Q. For the Duragesic patch in the 2003 time frame you are familiar with forward, what machine would that be?
A. It would be a Bodolay 1.
Q. Bodolay is B-O-D-O-L-A-Y?
A. Yes.
Q. You refer to that as Bodolay 1. Is there another Bodolay machine at the Alza plant?
A. Yes.
Q. Do you refer to that as Bodolay 2?
A. Yes.
Q. What is Bodolay 2 used for?
A. Nicoderm.
MR. ZELLERS: Without interrupting you, I think there is another machine that he didn't have an opportunity to tell you that made duragesic back at that time.
BY MR. ANGWIN:
Q. I'm sorry, go ahead.
A. Klockner.
Q. K-L-O-C-K-N-E-R?
A. Yes.
Q. Okay. So from the third quarter or fourth quarter of 2003 forward, the two machines that you were aware of that made the Duragesic patch were the Bodolay 1 and the Klockner?
A. Can you repeat the time frame, please.
Q. Start with 2003.
A. 2003, Bodolay 1, Klockner.
Q. Later on was another machine used?
A. Yes.
Q. What was that?
A. Harro Hofliger FFS or HHFFS.
MR. ANGWIN: We'll get you the spelling later if that's okay.
Q. And today are all three of those or which of those machines are used to manufacture Duragesic patches.
A. Bodolay 1 and HHFFS.
Q. Okay. Does that mean Klockner is no longer?
A. True.
Q. When was Klockner taken off the production of Duragesic?
A. Don't actually recall the exact dates. Sometimes between 2005 and early 2006.
Q. Was there a reason Klockner was no longer used?
MR. ZELLERS: Speculation. Foundation. Objection.
THE WITNESS: 25 microgram were not produced on HHFFS.
BY MR. ANGWIN:
Q. Okay. The next box there says die cut individual systems. Can you tell me what that involves?
A. Okay. You have a long continuous film where the gel is put and now you have a seal onto different film on top. And now the die cut operations mainly separates out the — cuts the film so you have now single system.
Q. Okay. Let me back up. On the form-filled seal operation, other than putting in the gel, is anything else done during that stage of the production?
A. From the step two, three, is performed on the same machine. It's called FFS. So form-filled seal and die cut are done at the exact same machine.
Q. Okay. And once step two and step three are finished, is there basically a finish product?
A. No.
Q. Okay. What happens?
A. Elaborate on step number four. It depends on how you define it. Package individual system is also done in FFS and final system is also in FFS. So entire operation that you see besides the step of mixing is Bodolay 1.
Q. Okay.
A. Everything happens in the same machine.
Q. So steps two, three, four and the final system would all happen on Bodolay 1?
A. Yes.
Q. That would include sealing the individual patches after the gel is placed in them?
A. Uh-huh.
Q. And then cutting them?
A. Uh-huh.
Q. You need to answer out loud.
A. Oh, sorry. And cutting them, yes.
Q. Where is the inspection process on this?
A. Several different steps, so it would depend on which process you are dealing with.
Q. Okay. I'm going to go through that in a moment.
A. Okay.
Q. We can go Into that.
Now, we talked about the manufacture of the Duragesic patch. And I'm going to show you a document Are you familiar with the construction of the a Duragesic patch?
A. Familiar as a manager, yes.
Q. Okay. Have you been- did you ever go through any training as to the components that made up the patch?
A. Yes.
Q. What a proper patch looks like?
A. Yes.
Q. How many patches are there?
A. Four.
Q. And were there —
A. Today, actually five.
Q. Okay. Let me back up. Were there four at the time that you began as the manager of the Duragesic line?
A. Yes.
Q. What strengths were those?
A. 25, 50, 75 and hundred.
Q. When you say 25, 50, 75 and a hundred, you are referring to micrograms?
A. Yes.
Q. For a layman, would that be the strength, the dosage strengths you are referring to?
A. Yes.
Q. Okay. You said there's a fifth patch today. Can you tell me which patch that is?
A. 12 and a half.
Q. Okay. When was the 12 and a half — when did you start manufacturing the 12 and a half?
A. Don't exactly remember. Sometime in 2004, 2005.
Q. Okay.
A. Probably 2005.
Q. 12 and a half, again, refers to the dosage strength?
A. Yes.
Q. I'll show you my copy. I'm showing you a document which has been produced which is marked DUR 0187325, second page DUR 0187326, and ask you, other than the highlights, have you seen that document before?
A. I have seen similar documents before.
Q. Okay. I'm not asking for that exact document, but the documents you have seen like that, does that represent in a general way a description of the Duragesic patch and the composition of the patch?
A. In general, yes.
Q. Yes. I know there are a lot of technical stuff to It, but generally, if I wanted to look at the patch, I could look at that and I would understand — let me show you.
I could look at this and understand what it is?
A. Yes.
Q. Okay.
MR. ZELLERS: Are we going to mark this document?
MR. ANGWIN: Yes, we're going to mark that as Exhibit 2.
(Whereupon, Exhibit 2 was marked for identification.)
MR. ZELLERS: Exhibit 2, as I understood it, was 187325-26.
MR. HARVEY: I have got it right here.
BY MR. ANGWIN:
Q. And I'm going to give you my layman's understanding of the patch. And if there is anything we need to clarify on that, please let me know.
But the way I understand it, there is a layer that is down there that also has an adhesive on it that sticks to the skin. There's gel.
There's a layer that seals on top and seals in the gel.
A. Uh-huh.
Q. Is that basically how the patch Is composed?
A. Exactly.
Q. All right That's how it was composed in the 2003 time frame when you became — when you started working on the Duragesic as a Duragesic manager?
A. Yes.
Q. And that's the same way it's done today?
A. Yes.
Q. And that's the reservoir type of patch; Is that correct?
A. Yes.
Q. And the Fentanyl gel that is enclosed, that would be the drug reservoir?
A. Yes.
Q. Okay. Good. I know that there are numerous companies — I have seen various e-mails — that are involved In the overall production or marketing of the Duragesic patch.
Do you have positions with any companies other than Alza?
MR. ZELLERS: Objection. Asked and answered.
And for the record, as I Indicated to you, Mr. Angwin, off the record, all of the folks who were Involved in the production and — In the production of the Duragesic patch worked with Alza. Janssen was also involved In terms of the manufacturing and distribution.
But there may be a lot of subentities that a particular witness may work for, but there is not an agency issue here.
MR. ANGWIN: Yeah, I appreciate that.
We're not — I'm not going into the agency. I just wanted to briefly ask if he worked for any other companies or any other entities, not even companies, within the Alza Janssen, Johnson & Johnson framework. For example, I think there is PG U.S.A.
THE WITNESS: Ortho-McNeil.
BY MR. ANGWIN:
Q. Ortho-McNeil?
A. Ortho-McNeil Pharmaceuticals.
Q. Is that a company you have worked for recently?
A. That's the unit that I hold position now.
Q. Yeah. Am I correct that Ortho-McNeil at some point took over the manufacture of the Duragesic patch?
MR. ZELLERS: Objection. Vague and ambiguous.
BY MR. ANGWIN:
Q. Let me back up.
How did Ortho-McNeil become involved in being your employer?
A. After the production manager job, I took a position as a global supply chain manager. Still stationed and worked for Alza, but belonged to Ortho-McNeil Pharmaceuticals.
Q. I guess I should have prefaced that with another question because I was not sure you had been promoted again.
How long did you work as the production manager on the transdermal operations?
A. From 2003 to 2006, January of 2006.
Q. In January of 2006, did you get a new job position?
A. Yes.
Q. Was that again a promotion?
A. It's the role with much, much, much larger responsibility, but yeah, it's a promotion.
Q. Okay. What is that new job position that you have?
A. As a global supply chain manager, I am responsible for managing the distribution of pharmaceutical products worldwide.
Q. All pharmaceutical products?
A. No. Several pharmaceutical products.
Q. Which products are those?
A. Concerta.
Q. Okay.
A. Ditropan, Jurnista.
Q. Can you spell that?
A. J-U-R-N-I-ST-A.
Q. Okay.
A. Elmiron. And there are several more.
Q. Are you any longer Involved in the — with Duragesic?
A. No.
Q. Okay. And that ended, I would assume, in January of 2006?
A. Yes.
Q. Okay. All right. But from the — from January 2003 through January 2006, you were the production manager for the transdermal operations which would have included the production of the Duragesic patch?
A. From 2000 January — from February 2003 to January 2006, I was the manager for transdermal operations responsible for the Duragesic started in Q3 of 2003.
Q. Okay. Thank you for clarifying that.
That lasted up through January 2006?
A. Yes.
Q. Okay. All right And the active ingredient in Duragesic, I believe you testified, is Fentanyl; is that correct?
A. Yes.
Q. As a chemist, do you know what Fentanyl is?
A. It's a chemical compound.
Q. Is it a pharmaceutical?
A. It's a pharmaceutical chemical compound.
Q. Okay. Is it — what is it used for?
A. It's used for treatment of pain.
Q. Okay.
A. Acute pain.
Q. Okay. And is Fentanyl — would I be correct as classifying that as an opioid?
A. Yes.
Q. And does that mean it's a synthetic narcotic? Would that be a layman's way to describe it?
A. Yes.
Q. And can you quantify for me whether Fentanyl Is a strong or a weak narcotic?
MR. ZELLERS: Objection. Vague and ambiguous.
THE WITNESS: Strong.
BY MR. ANGWIN:
Q. Can you tell me how strong?
MR. ZELLERS: Same objection.
BY MR. ANGWIN:
Q. For example, with relationship to one that a lot of people know about which is morphine. Can you tell me If it's stronger or weaker than morphine by size?
A. Couldn't tell you.
Q. I'm going to show you what we're going to mark as Exhibit 3 which is a document, DUR2 081376, and ask you if you have seen that document or a similar document before?
A. Similar document, yes.
Q. Okay. And I have highlighted the part on mine which I am going to ask you to look at which is right next to the word stop, it looks like there is a word stop —
A. Yeah.
Q. — representative of a stop sign. Can you read the first line — the first two lines above that.
A. Fentanyl is a highly toxic substance. Refer to SOP 05020-040 and follow all safety dress and reconciliation requirements, read and understand all Fentanyl hazard sheets.
Q. Okay. And at the top of that it looks like there is a date written in: 10/16/03. And there is an effective date —
A. Which one?
Q. Sorry. Right here. A handwritten note, 10/16/03, and up at the top it says: Effective date 8/22/03.
Can you read that?
A. Yes.
Q. Was this the — first of all, do you know what this document is?
A. It is MF, master formula. It's a copy — a page of the MF.
Q. What is master formula?
A. Master formula is the document that's followed to manufacture Duragesic.
Q. Okay.
A. Every product has a master formula.
Q. Okay. And the master formula, would you agree with the statement In it that Fentanyl is a highly toxic substance?
A. Yes.
Q. Okay. And that — was that your understanding at the time you began working with the Fentanyl products or product?
A. Yes.
Q. Okay. That's your understanding today?
A. Yes.
Q. Okay. If a person is exposed to Fentanyl, as a chemist, do you know, can a person die from exposure to Fentanyl?
A. Not in the gel form, but in the raw material form, yes.
Q. Are you saying that If a person is exposed to the gel form, they cannot die?
MR. ZELLERS: Objection. Speculation. Foundation.
BY MR. ANGWIN:
Q. Let me — as a chemist, is Fentanyl gel a lethal substance?
MR. ZELLERS: Speculation, foundation. Objection.
THE WITNESS: The dose that is manufactured, I don't believe so.
MR. ANGWIN: Okay.
Q. I'm not asking about the dosage. I'll get to that in a little bit.
Just generally, If you are exposed to a large amount of Fentanyl gel, can that kill a person?
MR. ZELLERS: Speculation. Foundation. Objection.
THE WITNESS: Not in my area of expertise. I could not comment.
BY MR. ANGWIN:
Q. As a chemist, you can't comment on that?
A. No.
Q. Okay.
A. It's too general a question.
(Whereupon, Exhibit 3 was marked for identification.)
BY MR. ANGWIN:
Q. Let me ask you, when workers work around the Fentanyl gel, do they take certain precautions so they don't come in contact with the gel?
A. Yes.
Q. Okay. And if a person comes in contact with the gel during the production process, with the Fentanyl gel, is there a procedure for what they are supposed to do? Was there a procedure in place back in the third quarter of 2003 when you took over?
A. Yes.
Q. What was that procedure?
A. Report to the nurse.
Q. Okay. Are they supposed to do anything with the gel before they report to the nurse?
A. Wash, take precaution — normal precaution and measure and wash it off because you don't want to have it stick on your skin anyway, and then to see the nurse.
Q. And were those steps undertaken because a person can suffer physical harm through exposure to Fentanyl gel?
MR. ZELLERS: Speculation. Foundation. Objection.
BY MR. ANGWIN:
Q. If you know.
A. I would be speculating.
Q. Okay. During the time that you were the production manager for transdermal operations, how much time on average did you spend with monitoring or working with the operations that involved production of the Duragesic product?
MR. ZELLERS: Objection. Overbroad.
THE WITNESS: Minimal.
BY MR. ANGWIN:
Q. Can you tell me what minimal means?
A. Minimal means a few minutes a day to nothing for a month.
Q. Okay. Did you spend more time on the other products, the Nicoderm Catapres, Scop, or Testoderm?
A. The answer would be the same because my role was a manager, not to be on the line or work with the workers.
Q. Okay. Maybe I'm — maybe that was an improper question.
With regard to any aspect of the production, whether it's managerial or supervisory, how much of your time from the time you began having responsibility for the Duragesic line did you spend on Duragesic as opposed to the other four products you were also responsible for?
A. Q3, Q4 of 2003, about 50 percent. Starting 2004, 100 percent.
Q. Okay. So from — would that be January 2004?
A. Yeah.
Q. So from January 2004, I assume through January 2006, were you exclusively working on the Duragesic productions?
A. Yes.
Q. Okay. And from your earlier statement, is it — am I correct that your job would be to interface with the supervisors and other personnel but it would not be to monitor the actual — go down and monitor the actual production line?
A. True.
Q. Okay. Who would be the person who would in the — from the time you took over through 2006, who would have been responsible more for the actual physical operation of the line?
A. The operators and the leads.
Q. Okay. And that gets me to the next question. From the time you — let's start with the time you took over responsibility for the Duragesic line.
How many personnel were there Involved in the actual production and manufacturing process that actually worked on the line during a given shift?
A. Nine operators in 2003, nine operators per line per shift. And you would roughly have nine to ten in a team, but nine would be a number.
Q. Okay. And when you say per line, would the Duragesic production, would that be a line?
A. Yes.
Q. Okay. Would that — would there be the same number of operators on the other production lines for example, Nicoderm?
A. Yes.
Q. Okay. I just want to clarify that.
A. Uh-huh.
Q. Okay. You said per shift How long in 2003 were the shifts?
A. 12 hours.
Q. Okay. And during the entire time that you worked with the Duragesic patch, were there 12-hour shifts?
A. Yes.
Q. During the entire time you worked with the Duragesic patch, would there have been a team of nine, but nine to ten operators working on the Duragesic line?
A. There were more starting 2004.
Q. Okay.
A. Post recall.
Q. Let's get back to the pre recall if I can, then I'll go on to the next one.
A. Uh-huh.
Q. If you turn back to Exhibit 1, which Is just the general description of the production, would the nine operators have been involved in any of those specific stages there numbered one, two, three, four?
A. The mixing, what you see is a drug reservoir a gel is a separate unit operation, not Bodolay 1. So two, three, four and the final is what is Bodolay 1, and there would be nine operators there.
Q. There would be nine on the operators on the Bodolay 1, and that would —
A. Include two, three, four, and whatever the final system is.
Q. Would that take the process from the gel and film actually being separate to the patch being created, punched, and packaged and ready for shipment?
A. Not ready for shipment but packaged.
Q. Okay. Packaged?
A. Yes.
Q. And is there a difference between packaged and cartoned?
A. Yes.
Q. Okay. And when I talk about it, I am going to talk about packaged. Am I correct that carton would be when it's actually put in cartons to be shipped out?
A. Yes.
Q. Okay.
MR. ZELLERS: Objection. Vague and ambiguous.
I don't think you two are on the same wavelength here.
BY MR. ANGWIN:
Q. Okay. Let's get back on the same wavelength.
Can you tell me the difference between packaging and cartoning?
A. Form-filled seal is a packaging line where you create a system, a finished system. The finished systems then are taken to a completely different operation which I call a cartoning, and those individual systems are bundled together in a group of five in one carton. And those cartons are then what constitute as the final product for shipment.
Q. Okay. And with regard to steps two, three, four and the final system, are there any inspections done of the finished product after this final system step?
MR. ZELLERS: You are speaking generally of manufacturing?
BY MR. ANGWIN:
Q. I'm sorry, manufacturing the Duragesic patch.
A. There are inspection from beginning to the finish, so it depends on what you — maybe I didn't understand your question.
Q. I'll try to rephrase.
A. Many inspections.
Q. I'm — we'll get into that.
At the point It becomes a final system, it sounded to me as if then it's just taken and then basically taken over to the shipping department and it's counted and put into cartons and shipped out.
A. No. Actually there is a whole different machine that puts them into a carton.
Q. Okay.
A. And there are several inspections during that cartoning process. So yes, there is inspections past the final system.
Q. Let's talk about, if I can, the Bodolay machine first, and we're going to get into some other areas.
Do you know when the Bodolay machine referred to as Bodolay 1 was acquired by Alza?
A. Don't know.
Q. Okay. Do you know when that machine was manufactured?
A. Don't know.
Q. That machine was there when you got there?
A. Yes.
Q. Same with the Bodolay 2?
A. Yes.
Q. Okay. And you can't quantify for me in any way if you get — those machines are new or old or were recent purchases?
A. I did not know when they were purchased.
Q. Okay. Had you had any experience with the Bodolay at any other time in any other job you have held?
A. No.
Q. Okay. So you wouldn't have any other knowledge about it?
A. No.
Q. Okay. Do you know — are you familiar with the way the Bodolay machine operates?
A. In general, yes.
Q. Okay. And am I correct that it is a continuous system in that the — when the film was placed on it, it goes in a continuous motion?
A. Uh-huh.
Q. Is that yes?
A. Yes.
Q. Okay. There are also two other machines you mentioned earlier, the Klockner and the HH?
A. Yes.
Q. Do those machines work the same way with the continuous motion?
A. Yes.
Q. Okay. Are there any differences between the way in which those machines — when I say that, the Bodolay, the Klockner, and the HH — function with regard to making a patch product?
MR. ZELLERS: Objection. Vague and ambiguous. Overbroad. Speculation.
THE WITNESS: In general, no.
BY MR. ANGWIN:
Q. Okay.
A. The process is the same.
Q. Okay. Let me ask you that Could — you testified that the reservoir patch was used for the Duragesic, but the matrix patch was used on the Catapres, Scopolamine, Testoderm, and the Nicoderm.
A. Yes.
Q. Which machines were, during the 2003/2004 time frame, were the Nicoderm patches manufactured on?
A. Bodolay 2, Circle 6. That's it.
Q. So am I correct that the Bodolay machine can manufacture both reservoir and matrix patches?
A. No.
Q. Explain that to me.
A. Bodolay 2 is a completely different machine than Bodolay 1.
Q. They are made by the same manufacturer but different machines?
A. I don't know if they are made by the same manufacture, but guessing by the name, maybe, but I don't know. They are completely different machines.
Q. When you say different machines, of course they are different machines, but they are different types of machines?
A. Yeah. The layout is completely different.
Q. What about the HH? That's a different machine, too?
A. Yes.
Q. Is it your understanding that the HH and Klockner were made by different manufacturers than made the Bodolay?
A. Yes.
Q. Okay. Could the machine that is the Bodolay 1, could that make any products other than form-filled seal products?
A. No.
Q. Okay. But there are machines that can make matrix products that were at the Alza plant in the 2003 time frame?
A. Yes.
Q. Okay. And those were there at the time you — were those there at the time you came to work fork Alza in 2002?
A. Yes.
Q. And do you know how long those machines had been there?
A. No.
Q. I'm going to go back to an earlier point just briefly.
(Off the record discussion.)
BY MR ANGWIN:
Q. Is there a medical department or a medical group at the Alza facility that is in charge of medical issues or medical questions with regard to the products?
A. Not stationed at Alza.
Q. Is there one that is within the framework of the company?
A. Yes.
Q. Do you know, In the 2003/2004 time frame, who was in charge of the — if I refer to that as medical, would that be the correct way to refer to it?
A. Yeah.
Q. Who was in charge of medical in 2003/2004?
A. Don't recall.
Q. Okay. Do you recall whether, prior to the recall, medical had made any statements about the dangers a person faced If they were exposed to Fentanyl gel?
MR. ZELLERS: Objection. Overbroad. Speculation.
THE WITNESS: Yes.
BY MR ANGWIN:
Q. Okay. Were there ever statements made by medical that exposure to Fentanyl gel could be lethal?
MR. ZELLERS: Speculation. Foundation. Objection.
BY MR. ANGWIN:
Q. If you know.
A. I don't know.
Q. You never heard anything like that?
A. No.
Q. Okay. Let me ask you, getting back to the matrix, reservoir questions, do you have an understanding of the various ways that those two patch technologies are manufactured?
A. Yes.
Q. Is patch technology, is that the correct way to refer to it?
A. That would be fine.
Q. Okay. And the do you know which of those technologies is the older technology, was created first?
MR. ZELLERS: Speculation. Foundation. Objection.
THE WITNESS: Wouldn't know.
BY MR. ANGWIN:
Q. Okay. Do you know which of those would be considered the more- the newer technology?
MR. ZELLERS: Same objection.
THE WITNESS: Couldn't answer.
BY MR. ANGWIN:
Q. Okay. With regard to the matrix patch, do you know why the Nicoderm, Catapres, Scop, and Testoderm were manufactured using matrix technology as opposed to reservoir technology?
A. I couldn't answer that.
Q. Do you know who would have made that decision?
A. Process engineering and R&D.
Q. Okay. That was made before you got there, obviously?
A. Way before.
Q. Okay. Do you know if there was ever any consideration given during the time you were there to manufacturing the Duragesic patch using matrix technology?
MR. ZELLERS: Speculation. Foundation. Objection.
THE WITNESS: Yes.
BY MR. ANGWIN:
Q. Okay. And when did you first become aware there was a discussion about using the matrix technology to manufacture the Duragesic patch?
MR. ZELLERS: Same objection.
THE WITNESS: I don't know exactly but sometime in 2003, I believe, or maybe it was before that. I don't know exactly.
BY MR. ANGWIN:
Q. Do you know how you came about that knowledge?
A. I came about that knowledge because registration batches were manufactured at Alza.
Q. Registration —
A. Batches.
Q. — batches? Okay.
A. Of matrix Duragesic.
Q. And when you say registration batches were manufactured, actually that there were matrix patches with Fentanyl gel in them that were manufactured under the Duragesic brand?
A. Not under Duragesic brand.
Q. Okay. I'm sorry. There were matrix patches manufactured with Fentanyl gel in them?
A. Yes.
Q. Okay. What was the purpose of manufacturing those?
MR. ZELLERS: Speculation. Foundation objection.
THE WITNESS: I don't know.
BY MR. ANGWIN:
Q. Were you involved in the manufacture?
A. No. I couldn't exactly recall that.
Q. I'm going to show you a document that has been marked as produced. It's Duragesic, DUR 0307412 and DUR 0307413. It's a letter dated March 14th, 2000. And ask you and your counsel to look at that It's a two-page document if you need to look at the second page.
Whenever you are ready, my first question is: Have you seen that document before?
A. I have not seen this document before.
Q. Okay. Does — I'm going to — of course the document speaks for itself, but just ask you a question.
It's a document dated March 14th, 2000.
By reading that document, does that indicate to you that, at least as of this date, that Alza had considered using the matrix technology to produce a Fentanyl transdermal patch?
A. Based on the document, yes.
Q. Okay. That's all I'm asking.
MR. ANGWIN: Mark that as Exhibit 4.
(Whereupon, Exhibit 4 was marked for Identification.)
BY MR. ANGWIN:
Q. With regard to issues such as whether matrix technology was used would have been used or considered, which group of Alza would be more involved in making that decision? Would that be manufacturing, production or another group?
A. Manufacturing is the tail end. We don't make decision on that. It would be primarily R&D.
Q. Research and development?
A. Yes.
Q. In the 2003/2004 time frame, do you know who was in charge of R&D at Alza that would have had responsibility for the Duragesic patch issues?
A. I don't recall the name.
Q. Okay. When you became aware In the — you say 2003 time frame?
A. Uh-huh.
Q. — of the fact a matrix patch was being considered, was that — were you presented with that information through a document or through a meeting or how did you come about it?
A. Don't exactly recall how I came about it. I knew we were making registration batches and that's how I knew.
Q. What would be the purpose of making registration batches of any product?
MR. ZELLERS: Speculation. Foundation overbroad. Objection.
BY MR. ANGWIN:
Q. If you know.
A. One answer would be to file for this manufacture and distribution.
Q. File, would that be with the governmental agency?
A. Yes.
Q. Which agency would that be with?
MR ZELLERS: Speculation. Foundation. Overbroad.
THE WITNESS: I couldn't exactly say.
BY MR. ANGWIN:
Q. Would I be correct that prior to putting any pharmaceutical product on it, you have a general understanding that there is a certain registration process that is involved?
A. In general, yes.
Q. Would these registration samples that were created, would that have been, your understanding, somehow involved in moving forward with that registration process?
MR ZELLERS Same objections.
THE WITNESS: Yes.
BY MR. ANGWN:
Q. Okay. And I guess I get down to this. In the 2003 time frame, was the technology available to produce a matrix Fentanyl patch, transdermal patch?
MR. ZELLERS: Speculation. Foundation. Objection.
THE WITNESS: Yes.
BY MR. ANGWIN:
Q. And did Alza have that technology?
MR. ZELLERS: Same objection.
THE WITNESS: Couldn't exactly say yes to that But in general, yes.
BY MR. ANGWIN:
Q. Okay. Did Alza have the machinery where they could make a matrix Fentanyl patch in the 2003 time frame?
MR ZELLERS: Same objection.
THE WITNESS: Yes.
BY MR ANGWIN:
Q. Okay. And do you know if any technological or logistical impediments that would have kept Alza from creating a matrix Fentanyl patch prior to 2004 if they desired to do so?
MR. ZELLERS: Same objection.
THE WITNESS: I would let the expert answer that, but in my limited experience, it was very difficult to make.
BY MR ANGWIN:
Q. Let me ask you this. If they had come — if your superiors had come to you in 2003 and said we want to make a matrix Fentanyl patch, and here is what we want you to do, could you have accomplished that task?
MR ZELLERS: Same objection. Also incomplete hypothetical.
THE WITNESS: Once again, I would have to have the process engineers and equipment engineers answer that, but I know it was difficult to make.
BY MR ANGWIN:
Q. Okay. That's more an engineering question for the process engineers?
A. Process and equipment engineer would be, you know.
Q. Would one of the process engineers be Dave Chullino?
MR ZELLERS: Speculation. Foundation.
THE WITNESS: Yes.
BY MR. ANGWIN:
Q. Okay. With regard to the matrix patch, do you know any advantages that the matrix patch has over a reservoir patch?
MR ZELLERS: Vague and ambiguous. Overbroad. Objection.
THE WITNESS: Don't know.
BY MR. ANGWIN:
Q. Let's go to a Fentanyl matrix patch versus a Fentanyl reservoir patch. Are you — do you understand that there are currently Fentanyl matrix patches that are manufactured that are used transdermally?
A. Yes.
Q. Do you understand that Duragesic still manufacturers a reservoir patch? When I say reservoir, a reservoir transdermal Fentanyl patch.
A. Duragesic, yes.
Q. Does any other entity manufacture a transdermal reservoir Fentanyl patch that you are aware of?
A. No.
Q. Okay.
A. I don't know.
Q. You don't know. So at least as of today, there is technology and there is commercially available matrix and reservoir Fentanyl patches?
A. Yes.
Q. Okay. With regard to the matrix patch, would I be correct that one of the differences between a matrix and a reservoir patch is that a matrix patch cannot leak gel?
A. Yes and no. It depends. Even in matrix system, you can ooze gel.
Q. Okay. When you say ooze gel, can you explain that to me a little clearer?
A. A matrix system has a backing that is slit in the middle for the purpose of peeling it off by the patient or the person who is going to apply that.
In that slit area, based on the temperature, you can have oozing. It's different than leaking, I guess. But if you don't go on exact definition, yes, you can have leakage.
Q. Do you know someone with Alza named Susan Rinne, R-I-N-N-E?
A. Sue Rinne. The name sounds familiar. I have heard that name but I don't know exactly.
Q. If I told you that she signed a letter on October 21st, 2004 as the vice president of regulatory affairs, would that refresh your recollection?
A. That would be accurate.
Q. Okay. I'm going to show you a composite document that appears to be a letter, Bates numbered DUR 0000969 through DUR 0000976, and ask you if you have seen that document before. I don't think you would have, but you are welcome to look at it.
I'll note for you I have highlighted a portion on the document that was my highlighting that was not on the original.
A. I have not seen this document before.
Q. Okay. This document, am I correct that it appears dated October 21st, 2004?
A. That's the date listed on the document.
Q. Okay. It's from someone at Alza?
A. Yes.
Q. Okay. Is it to the Food and Drug Administration? Is that what the document states?
A. Actually the document states to the CEDER of FDA.
Q. Center For Drug Evaluation and Research, Food and Drug Administration.
A. Yes.
MR. ZELLERS: Are we marking this as an exhibit?
MR. ANGWIN: Yes. We are marking this as Exhibit 5. I was going to identify it first and then go through and mark it.
Q. On the second page I highlighted a portion which appear to be in the bottom full paragraph.
Can you read the portion I've highlighted, please.
A. Matrix products do afford some advantages over reservoir products in terms of cosmetics, adhesion, and in the elimination of the possibility of gel leakage.
Q. Okay. So would I be correct that when — let me back up.
The term leak, he just used the term the term ooze which I have not seen used. When we talk about leaking patches, is leaking a term that has been used with regard to production, manufacturing, and inspection of the Duragesic patch during the time you have been involved with the patch?
A. We use the term unsealed channel.
Q. Okay. Would that be — when I say unsealed channel, would that be your definition of leaking patch?
A. Yes.
Q. Am I correct that's a patch where the Fentanyl gel is coming out of the reservoir area but is not going — not coming out through the polymer membrane but is coming out somehow in another manner?
MR. ZELLERS: Objection. Vague and ambiguous. Overbroad.
THE WITNESS: Yes and no. Two different things. The gel can ooze out of a leak out of the main reservoir with the seal still being intact. So it's unsealed channel with the seal intact.
MR. ANGWIN: One second. I am going to mark this as Exhibit 5 before I forget.
(Whereupon, Exhibit 5 was marked for identification.)
BY MR. ANGWIN:
Q. And I'm glad you brought that up because I have been dying to understand what an unsealed channel is.
A. Okay.
Q. Can you explain that for me?
A. Yes.
Q. When you talk about that, am I correct that unsealed channel is a term that would only apply to a reservoir patch?
A. Yes.
Q. And the only reservoir patch that was manufactured would have been the Duragesic patch?
A. Yes.
Q. So we are talking about Duragesic patches now?
A. Yes.
Q. Okay. Tell me what an unsealed channel is.
A. An unsealed channel is when a small area of the seal is not properly sealed, thereby presenting a scenario when if pressure applied, small amount of gel can come out of the reservoir.
Q. Is that — are you finished?
A. No.
Q. Okay.
A. So I was talking about two different scenarios. One is unsealed channel with the seal still intact, which means the inner seal can be — might be minute openings in the inner seal with the outer layer still intact so there will be no leakage. Another scenario would be that the outer seal also has a little bit of opening where the possibility of gel could come out. Yes.
Q. Okay. When you say the inner seal and the outer seal, we're talking — we went through earlier on Exhibit — one of the exhibits, it shows a basic — here it is. Exhibit 2. Shows a basic diagram of the patch; is that correct?
A. Yes.
Q. When you say inner seal and outer seal, first of all, were those the terms you just used?
A. Inner seal, outer seal.
Q. Inner seal, would that be the area that's sealed in nearest to the reservoir?
A. Yes.
Q. Outer seal, would that be the edge of the patch itself?
A. Yes.
Q. Between the inner seal and the outer seal, is there a —
A. Closer to the edge but not edge itself.
Q. Closer to the edge. And is there a continuous seal between the Inner seal — is there — designed to be a continuous seal between the inner seal and the outer seal?
A. Yes.
Q. And there Is — I believe there Is some pressure or — and heat applied to actually seal those two layers, the top layer —
A. Yes.
Q. — and the bottom layer together.
A. Yes.
Q. Okay. All right So when you talk about an unsealed channel, are you saying that relates to both the inner seal or the outer seal being not fully sealed?
A. A small area not fully sealed.
Q. Okay. If the outer seal is not fully sealed and the inner seal is sealed, can that occur?
A. There's always a possibility, but I don't know. Yes, it can occur.
Q. Would there be a potential for gel leakage in that scenario?
A. No.
Q. Am I correct it's only when the inner seal is not fully sealed could you have gel leakage from the reservoir?
A. No. The inner seal and the outer seal —
Q. I wasn't trying to trick you on that I was going to say both of those have to be —
A. Yes.
Q. Let me finish the question first.
A. Sorry.
Q. Both the inner seal and outer seal have to have a problem with seal integrity for there to be a leak?
A. Yes.
Q. Okay. And when — that's an unsealed channel?
A. Yes.
Q. So an unsealed channel would be a breach in the seal that allows, I guess, a channel for the gel In the reservoir to come out.
A. Yes.
Q. Okay. Good. Now, we got to that whole thing because I was talking about the term leakers.
A. Uh-huh.
Q. Is that yes?
A. Yes.
Q. And is leakers a term that Is used when one describes or has been used to describe a defective Fentanyl patch, Duragesic patch?
A. Yes.
Q. Is that a term that's used at Alza?
A. Normally, leaker is a layman term, but we used unsealed channel, but yeah, it has been used.
Q. Okay. Does unsealed channel include — Is that a general category that include all types of leakers?
A. All types of sealed breaches, yes.
Q. Would that include foldover defects?
A. Yes.
Q. Would that include seal and gel?
A. Gel and seal?
Q. I'm sorry, gel and seal Yeah, reverse that.
A. Yeah, it would.
Q. Would that Include classic leaker?
A. What is a classic?
Q. I think It's — I have seen the term classic leaker, stringer leaker and classic stringer leaker —
A. Interchangeable, yes.
Q. Classic stringer leaker. So are those — have you heard the term stringer leaker before?
A. Yes.
Q. Is that a term that's used at Alza?
A. No.
Q. If I had documents that used that term, would I be able — would you — never mind. If a person has used that term at Alza, do you understand what that term means?
A. Yes.
Q. And is that the — is that term interchangeable? The way It's used, stringer leaker, classic stringer leaker, and classic leaker, is it your understanding those all describe the same type of leaker?
MR. ZELLERS: Objection. Speculation. Foundation. Vague and ambiguous. Overbroad.
BY MR. ANGWIN:
Q. If you know.
A. Don't know, but in general, yes.
Q. Okay.
A. Throughout the investigation, it has been interchanged and used so much that I think people perceive that as being the same thing. I don't know.
Q. When you say the Investigation, is that the investigation of the 2004 recall?
A. Yes.
Q. Okay. And so If I used the term stringer leaker, you are familiar with what that term means?
A. Yes. If you catch me off guard, I might say no, but yes.
MR. ZELLERS: Is a stringer leaker different than a foldover defect —
MR. ANGWIN: I was about to get to that.
Thank you.
MR. ZELLERS: Please do.
BY MR. ANGWIN:
Q. Certainly. Explain to me what a stringer leaker is.
A. A stringer leaker, as I understand and used in the investigation, is what I call the unsealed channel, but there is a minute opening in the seal enabling the gel to leak out.
Q. Would that minute opening be caused by a string or portion of gel that interfered with the proper adherence of the two films?
A. Absolutely.
Q. Okay. And that — would that fall under the category of unsealed channel?
A. Yes.
Q. All right. And when — your able counsel just pointed out foldover defect. I am going to get Into that In more detail, but is a foldover defect another type of unsealed channel?
MR ZELLERS: Vague and ambiguous.
THE WITNESS: A foldover defect is another type of seal breach.
BY MR. ANGWIN:
Q. Would that fall under your heading, as you understand it, of unsealed channel or separate heading?
MR. ZELLERS: Same objection.
THE WITNESS: It would fall under the definition of seal breach.
BY MR. ANGWIN:
Q. Okay. And I'm not — I'm trying to understand, I want to get a term that is sort of an overarching term to categorize all of these, and I want to go through each one. I thought that was unsealed channel, but apparently that is not. Would seal breach the overarching term that can describe all of those —
A. Yes.
Q. — problems?
A. Yes. System seal breach.
Q. Okay. System seal breach. And that would include unsealed channels?
A. That would include any and all issues if they occur on the seal side of the system.
Q. Can you state for me all the types of system seal breaches that you are aware of that can occur in a Fentanyl Duragesic patch?
MR. ZELLERS: You are speaking of the manufacturing process or at any time, anyplace?
BY MR. ANGWIN:
Q. Okay. I will clarify that During the manufacturing process, do — are system seal breaches found?
A. Yes.
Q. Okay. And I would assume there are different types of system seal breaches that are found.
A. Yes.
Q. During the manufacturing process, can you tell me all the types of system seal breaches that you are aware of that have been found with regard to the Duragesic patch?
A. Gel in the seal area.
Q. Can we call that gel and seal? Is that a proper —
A. That's proper.
Q. Okay.
A. Unsealed channel.
Q. We just discussed that.
A. Yes. And cut system.
Q. Okay.
A. That's it.
Q. Okay. What about foldover defect? Would that fall under one of those categories?
A. In the normal manufacturing process, I am not aware of foldover defect being created that I am aware of.
Q. Are you aware that foldover defects have been reported and found on Duragesic patches?
A. Yes.
Q. Okay. So if I were going to categorize folder defects, would they fall into one of these three categories or would they be a separate —
A. No, they would be a seal breach. They wouldn't be separate category.
Q. You just talked about — when I say category, let me rephrase. I want to know all the kinds of seal system — system seal breaches that can occur during the manufacturing process.
A. Okay. One kind of seal breaches would be unsealed channel with seal not intact. Like on one side or all sides can be. So completely not sealed on one side. So unsealed channel with one — or one side of a seal not intact.
Q. Would that be a category under which a foldover defect would fall?
A. Yes.
Q. Okay. So gel and seal.
A. Uh-huh.
Q. Unsealed channel, which would include seal not intact which includes foldover defect, and cut system.
A. Yes.
Q. Are those the three types of system seal breaches that you are aware of, whether you are personally aware or have read about them —
A. Yes.
Q. — that can occur with the Duragesic patch during the manufacturing and production process?
A. Yes.
Q. Any others?
A. No.
Q. Okay.
A. Not that I'm aware of.
Q. Okay.
MR. ANGWIN: Can we take a break for a minute.
MR. ZELLERS: Yes.
THE VIDEOGRAPHER: Going off the record.
The time is 10:38 a.m.
(Whereupon, a brief recess was taken.)
THE VIDEOGRAPHER: The time is 10:51 a.m.
BY MR ANGWIN:
Q. Mr. Panda, I think we were talking about defects and I think we had a little miscommunication there.
Can you go ahead and, I think, respond to my last question?
A. In the manufacturing process, there are several types of seal defects that I a aware of: the gel in the sale area; unsealed channel, which has been given other names as a stringer leaker or a classic leaker; cut system; unsealed system with one side completely unsealed — one or more sides, I should elaborate; short seal; and long seals.
Q. Okay. And the unsealed system with one or more sides completely unsealed, would that include the foldover defect?
A. That would classify as a foldover defect.
Q. Okay. Good. What Is a sort seal?
A. Between the inner edge of the seal and outer edge of the seal, there is a specification. It has to be certain specification.
When the die cut operation cuts it shorter than that, it's called a short seal; or if you have more space left, it's called a long seal.
Q. And a short seal, is that where the die cut is so close that actually there is not enough seal to prevent leaks if there is pressure applied?
A. A short seal would be a die cut system where the outer edge of the seal area was actually cut.
Q. Okay. Actually cut through. What about long seal, how could that result in a leak?
A. It cannot result in a leak. It just does not follow the QA specification, and fall in the quality just cannot produce that.
Q. Okay. So those others could result in a situation where Fentanyl gel is leaking from the system but a long seal would not?
A. That is true.
Q. Okay. I'm not saying long seal is acceptable. I'm saying it would not result In a leak.
A. Yes.
Q. Okay. Good.
We had talked generally about the machines that were Involved during the 2003/2004 time frame that produced Duragesic patch.
A. Yes.
Q. Now, I'm going to show you a document that has been produced and designated as DUR 029714 and DUR 029715, which appears to be a string of e-mails, and ask if you have seen that?
MR. ANGWIN: And we'll mark that as Exhibit 6.
(Whereupon, Exhibit 6 was marked for identification.)
BY MR. ANGWIN:
Q. I'll ask you after you reviewed that if you have ever seen that document.
A. I have not seen this document.
Q. Okay. I know that probably the persons who are on the e-mail string would be the better persons to ask, but I have a couple quick questions for you if I may.
A. Sure.
Q. The first, under subject, it says: Stringers slash leakers on Duragesic 12s. Right up here at the top.
A. Yes.
Q. Okay. Also I want you to look at that and look at the date. March 31st, 2004, was that after the recall of the 192 lot?
A. Not the 192. It was after the recall, yes.
Q. When I say recall, for sake of reference, should we refer to that as the 2004 recall?
A. 2004 recall.
Q. And when you use that term, does that include — how many lots does that include when you use that term?
A. All the lots that are recalled.
Q. I'm not trying — just different people refer to it in different ways. And I don't want to go into the recall too much, but unless said otherwise, can we assume when we use the term 2004 recall, we are referring to any of the recalls that included the five lots that occurred in the spring of 2004?
A. Yes.
Q. Okay. Good. Do you know if this was written before or around the time of the 2004 recall?
A. The recall was on February 11th, 2004. So this was post recall.
Q. Okay.
MR. ZELLERS: And so our record Is clear, I believe the first recall was done on February 16th of 2004.
THE WITNESS: Yes.
MR ANGWIN: Right. This would be the recall of the 192?
MR. ZELLERS: Correct.
MR. ANGWIN: We'll go Into that in a moment.
Q. And when it says Duragesic 12, is that the 12.5 microgram patch?
A. Yes.
Q. Are those referred to as Duragesic 12?
A. Yes.
Q. And the reason I brought this up is It appears to refer to the Bodolay 1, the Klockner, and the Harro Hofliger?
A. Yes.
Q. When were those the three machines that were producing Duragesic patches during that time frame?
MR. ZELLERS: Objection. Vague and ambiguous as to that time frame.
BY MR. ANGWIN:
Q. The March 31st, 2004 time frame relevant to the e-mail.
A. Yes.
Q. Okay. And one area that they discussed later on — and I'll point you to it specifically — deals with the nozzles and stringer leakers.
A. Yes.
Q. When I say nozzles, do you understand what that term means?
A. Yes.
Q. Are those also called — let me back up. Tell me what nozzles and dosing heads are.
A. Same thing.
Q. Those same interchangeable terms?
A. Yes.
Q. And are those part of the machines that are used to make form-filled patches?
A. Yes.
Q. And what is their function?
A. Their function is to dispense gel onto the film.
Q. So they would be the apparatus through which the gel flows onto the film?
A. Yes.
Q. And did — prior to the recall, did the Duragesic — I'm sorry. Did the Bodolay 1 use a different nozzle head than the HH or the Klockner?
A. Yes.
Q. Can you tell me the differences?
MR. ZELLERS: Vague and ambiguous. Overbroad. Go ahead.
THE WITNESS: I'll tell the way I know it.
BY MR. ANGWIN:
Q. That's exactly what I want.
A. Klockner and HH has a long nozzle to dispense the gel. It's a stationary nozzle, so it moves, it stops, puts some gel and let the film move and then stops, puts some gel. It's a long piece of tube, steel.
On Bodolay 1, the nozzles are different where they are continuous motion nozzle. The film never stops. So the head comes down, dispenses the gel, moves back up, comes down, dispenses gel. It's not a straight nozzle. It's a gap.
Q. So on the HH and the Kiockner, does the film stop at some point during the process when the gel Is being placed onto the film?
A. Yes.
Q. And I don't want to say jerking in a bad way, but Is that somewhat of a motion where it goes and stops, goes, stops?
A. Yes.
Q. And am I correct on the Bodolay 1 that it's continuous and the film moves continually?
A. Yes.
Q. All right Are you aware of any discussion as to whether either of those systems and I'll say the Bodolay 1 type of system with continuous movement and the HH, Klockner as the secondary type with the sort of stop and start, as to whether either one of those was more likely to produce a stringer leaker?
A. Bodolay 1 would be more likely to produce a stringer leaker.
Q. And were you aware of that when you took over production in — or responsibility for production in 2003?
A. Yes.
Q. Were you specifically told that?
A. No.
Q. Was that a well-known fact at Alza?
MR. ZELLERS: Objection. Vague and ambiguous. Overbroad.
BY MR. ANGWIN:
Q. At the time you took over in 2003.
MR. ZELLERS: Same objection.
THE WITNESS: 2003, I couldn't comment because I had just taken over, didn't know much. I think 2004 I became more aware of it.
BY MR. ANGWIN:
Q. Was that prior to the recall?
A. Couldn't tell you the time frame.
Q. How did you become aware of it?
A. We did a dosing optimization study.
Q. What is a dosing optimization study?
A. A dosing optimization study is study conducted by engineering to ensure that the timing of the dosing station is properly studied so we do not have any occurrence of stringer leak or, in my term, unsealed channel.
Q. Okay.
MR. HARVEY: What was the study again? A dosing what.
THE WITNESS: If the timing of the dosing head coming down, moving and coming back up is not accurate, then there is a likelihood that there will be tail of gel that can caught between in the seal area and you would not seal properly.
BY MR. ANGWIN:
Q. I think he was asking what the technical name for that study was.
A. Dosing head optimization.
Q. Okay. If we were to request that, we would request that study by that name?
A. Yes.
Q. Was that done more than once?
A. I don't recall.
Q. Okay. All right The — getting back to the dispensing nozzles, also called the dosing nozzle; am I correct?
A. Yes.
Q. Was there ever consideration given to changing the dosing nozzles that were on the Bodolay to — was there ever any thought given to changing those?
A. Yes.
MR. ZELLERS: Speculation. Foundation. Objection.
BY MR ANGWIN:
Q. During what time frame?
A. Couldn't tell you what exact time frame, but there was discussion.
Q. Okay. And would that have been a change to have nozzles that were more similar to those that were used on the HH and Klockner?
A. Yes.
MR. ZELLERS: Same objection.
BY MR. ANGWIN:
Q. Okay. What would have been the reason for that change?
MR. ZELLERS: Same objection. Speculation. Foundation.
THE WITNESS: The reason would be exactly like was mentioning, so that there is no tall of gel — a likelihood of the tail of gel being caught in the seal would be reduced.
BY MR. ANGWIN:
Q. That would lead to less chances of stringer leakers being created?
A. Purpose, yes.
Q. That's one of the — that's the main purpose?
A. Yes.
Q. That would be to have less seal breaches —
A. Yes.
Q. — in the production?
MR. ZELLERS: When you say seal breaches, it's what we refer to as channel leakers or stringer leakers?
MR. ANGWIN: Well, I was trying to get back to a generalized term so I didn't have to specify which one, but — because I thought he said system seal breach encompassed everything.
THE WITNESS: Yes, but —
BY MR ANGWIN:
Q. Let me clarify. I'm not trying to trick you into saying that.
The system seal breaches we were talking about would be classic stringer leakers?
A. Yes.
Q. Which would fall under the category of unsealed channel?
A. Yes.
MR. ANGWIN: It doesn't take me long to learn.
Q. Who was involved in doing that study?
A. Equipment engineering.
Q. Is that under production or what — who is that under?
A. It would be under engineering.
Q. Engineering is separate from production?
A. Yes.
Q. Okay. Who would be in charge of engineering during the 2003/2004 time frame, if you recall?
MR. ZELLERS: Overbroad. Objection.
THE WITNESS: Don't quite know exactly who was in charge at that time. Maybe the same person as today, but I don't recall.
BY MR. ANGWIN:
Q. Do you know If those documents have been retained anywhere, the documents related to the study?
A. If it is equipment engineering study, definitely.
Q. Where would those have been retained?
A. Under ECN.
Q. ECN?
A. Engineering change notice.
Q. Are the ECN, are those numbered sequentially?
A. Don't know.
Q. You don't know how they are designated?
A. No.
Q. Okay. I want to go back to the e-mail string for a moment Look under the heading a little over halfway down that says summary. Do you see that?
A. Yes.
Q. Can you read that — that sentence right there?
A. While all three pieces of equipment can have occurrences of gel in the seal, the upgraded nozzle style is less likely to have the occurrence.
Q. When they say three pieces of equipment there, am I correct they are referring to the Klockner, the Harro Hofliger, and the Bodolay 1?
A. From the e-mail I would say yes.
Q. Is that consistent with your understanding that the upgraded nozzle would have led to — was hoped to lead to less occurrences of classic stringer leakers? Was that the purpose for considering the dosing head change?
MR. ZELLERS: Objection. Document speaks for itself. Speculation. Foundation.
MR. ANGWIN: I am not asking about the document. I am asking — let's back up.
Q. I thought you testified you had personal knowledge that dosing heads — there was a consideration given to changing the dosing heads.
A. Yes.
Q. And is this document consistent with your understanding of the reasons for that change?
A. Yes and no. At one time, we thought that it would help to change the nozzle on Bodolay 1, and it turns out it didn't work.
Q. I want to go through that real quick. The last line on the first page, down there, it looks like from Dave Chullino, it says:
The small leakers should be reduced by using the HH as it contains the upgraded high-bar dosing nozzles similar to Klockner.
A. Yes.
Q. Are those the type of dosing nozzles you were considering using on the Bodolay?
A. Yes.
Q. The next sentence:
We are also planning to update Bodolay 1 to these nozzles, although it will take about six weeks to receive them.
A. Yes.
Q. Are you saying — do you have any understanding as to whether those dosing nozzles were actually put on the Bodolay 1?
A. I don't recall the specifics. I know that equipment engineering did try and it did not work.
Whether they were actually put on, don't know how it was evaluated, but it was evaluated to be not used in Bodolay 1.
Q. Do you know the reasons that they didn't work or they were not used?
A. I don't know the exact reasons, but they didn't work as intended.
Q. Okay. Do you know of any other changes that were made to the Bodolay — I'm going to designate here between — I'm not talking about changes in personnel or testing kind of things right now. I am talking about actual physical changes to the machine.
A. Okay.
Q. Do you know of any changes that were made to the Bodolay 1 following the recall?
A. Yes.
Q. Okay. Can you tell me those changes?
A. Several changes.
Q. Again, right now, I want to deal with just actual changes to the machine —
A. Yes, equipment itself.
The pull wheels on the Bodolay 1 were replaced by a wider pull wheels. A flattener was added prior to the dosing station to ensure that the web is always flat. Edge guides or web guides were added pre and post dosing station or sealing station to ensure that the web is always in place.
A. Vision system was installed on the equipment, and a cut system sensor was either installed or upgraded. I think it was always there. It was upgraded.
Q. Okay.
A. That's the one I recalled.
Q. Were there also — okay. I'm not trying to — I know you were not looking at documents now, so if there is something else, that's fine.
Also, were there changes made to other aspects of the production and manufacturing process following the 2004 recall?
A. Equipmentwise, no.
Q. Let me —
A. Testingwise, yes.
Q. Okay. I want to go through some of those. I want to show you a document which has been marked DUR2 070958 and DUR2 079 — I'm sorry, 070959, and ask if you have seen that two-page document before.
A. Yes, I have seen this document before.
Q. Okay, What is that document?
By the way, I have highlighted two terms there. I'm not representing that those were on the original.
A. It is a document detailing the corrective actions performed on Bodolay 1.
Q. By the way, let me switch that I have an unmarked copy here. Go ahead, sir, tell me what it was.
A. It is a document listing the changes made to Bodolay 1 equipment and procedure. And it is attached to departure 200400418.
Q. Okay. Am I correct that departure 200400418 is the departure notice relating to the 2004 recall?
A. Yes.
Q. Does that relate specifically to the 192 lot or to all the lots?
A. The entire recall.
Q. Okay. All right. Were you involved In drafting anything or putting any information into this two-page document here?
A. The departure is a quite a long departure.
Yes, I was involved in providing a lot of this information and some of this information, yes, came from me.
MR. ANGWIN: Let's go ahead and mark that as Exhibit 7.
(Whereupon, Exhibit 7 was marked for identification.)
BY MR. ANGWIN:
Q. I want to go through these briefly if I can. And I know, again, this is part of a larger document; am I correct?
A. Yes.
Q. Which we'll go to later.
And second line looking at says:
Heightened inspection requirements/corrective actions identified as of 3/11/04.
A. Yes.
Q. Okay. And I think your counsel told you earlier. Are you aware that the first part of the recall occurred around February 16th of 2004?
A. Yes.
Q. Okay. With that operational date, I want to go to some of the actions committed to as well as the status and discuss those briefly.
A. Uh-huh.
Q. The first one is — appears to deal with operator training. Do you know — did you have any input into creating or providing information on that category?
A. Not creating, but making sure that that training was performed.
Q. Okay. Was that different training that was performed prior to the 2004 recall?
MR ZELLERS: Objection. Overbroad. Ambiguous.
BY MR ANGWIN:
Q. Was there a change in the training as a result of the — after the recall?
A. No. A training would be a normal part of any investigation.
Q. Okay. Let me make that a little clearer. Am I correct that the 2004 recall involved a foldover defect?
A. Yes.
Q. And a foldover defect is one of the terms you talked about earlier which would be unsealed system with one or more sides completely unsealed.
A. Yes.
Q. And that's a — that's a defect that can allow gel to leak from the reservoir.
A. Yes.
Q. When did you first become aware that a foldover defect could occur with — during the manufacturing process of the Duragesic patch?
A. When we received field complaint and, thus, this investigation was opened.
Q. Okay. And that would be sometime in February of 2004?
A. Yes.
Q. Okay. Are you aware or were you later made aware that as early as 2001, a foldover defect had been detected with the Duragesic patch?
A. During the course of this investigation, I was informed of that.
Q. Okay. And just to clarify, you were never told that a foldover defect could even exist until after the recall?
A. True.
Q. You were the person from 2003 forward who was actually in charge of the entire Duragesic production?
A. Third quarter 2003, onwards, yes.
Q. Sitting here today, do you think that that — that the knowledge that foldover defect could occur Is an important piece of information for the Duragesic production manager to have?
MR. ZELLERS: Objection. Speculation. Foundation. Overbroad.
THE WITNESS: It's a seal breach. So I mean, I don't think somebody has to tell me that foldover defect can occur. Any kind of seal breach can occur.
BY MR. ANGWIN:
Q. Well, not any kind. You listed here the kinds that can occur —
A. Yeah.
Q. There are —
A. Yeah, one of those kinds, yes. And I would have categorized foldover as one or the other side not sealed, one or more side not sealed.
Q. Which is a separate category?
A. No. It's a seal breach category, which a system with one or more sides not sealed.
Q. Right Other than a foldover defect, are there any other defects that can have unsealed system with one or more sides completely unsealed?
A. Yes.
Q. What would that be?
A. If the pressure or temperature parts portion of the equipment fails and you would have not sealed.
Q. So no seal is actually ever created?
A. No seals.
Q. Did you help train your replacement that took over the responsibility for Duragesic production in — when you left in 2006?
A. No.
Q. Did you have any conversations with that person?
A. Yes.
Q. Okay. Do you know if that person was made aware that a foldover defect could occur?
A. Yes.
Q. But you were not given that information when you took over?
MR. ZELLERS: Objection. Vague and ambiguous. In terms of the specific words, foldover. That's your question?
MR. ANGWIN: I'm asking if he was ever told before when he took over if a foldover defect was something that could occur and had been seen before in a Duragesic patch.
MR. ZELLERS: That's asked and answered but go ahead.
THE WITNESS: Specific term foldover was not used, but, as I understand, a system that is not sealed on one or more sides is same as foldover defect. So in that sense, yes, I was told — aware, but term foldover was not used.
BY MR. ANGWIN:
Q. Is the foldover defect a specific type of defect that is identifiable upon inspection?
A. Yes
Q. Okay. And that's different from the other example you gave of the — not being seal integrity because of lack of pressure or lack of heat; they are physically different?
A. It would be the same.
Q. The result is the same but they are physically different as far as the defect, aren't they?
A. Appearance is different, yes.
Q. Appearance and they are physically different There Is not a foldover in the second category, is there?
A. You are right.
Q. So the foldover defect Is a distinct type of defect, isn't it?
MR. ZELLERS: Objection. Vague and ambiguous. Overbroad.
THE WITNESS: Well, it is a type of seal breach but —
BY MR. ANGWIN:
Q. If I laid out ten patches here, and one was a foldover defect and the only one, you could pick It out?
A. Yes.
Q. So it's a distinct type of defect; am I correct?
A. In that sense, yes.
MR. ZELLERS: Same objections.
BY MR. ANGWIN:
Q. Did you have any training with regard to seal breach defects when you took over responsibility for Duragesic production?
A. No.
Q. Was that —
A. Training in the sense I was not asked to identify.
Q. Were you made aware that seal breaches could occur?
A. Yes.
Q. Were you made aware that seal breaches were a problem?
A. Yes.
Q. Were you made aware that there was an effort to eliminate or reduce seal breaches?
A. Yes.
Q. Were you told that there were different types of seal breaches?
A. Yes.
Q. Which seal breaches were you told about?
A. The ones I listed down.
Q. You listed gel and seal area. Were you told about that?
A. Yes.
Q. You listed unsealed channel which is also the stringer leak. Were you told about that?
A. Yes.
Q. You listed cut systems. Were you told about that?
A. Yes.
Q. You listed unsealed system with one or more sides completely unsealed. Were you told about that?
A. Yes.
Q. Okay. What about foldover defect?
A. The term foldover was never used.
Q. Alt right I'm sorry, let's go back through this.
A. Okay.
Q. The training that was undertaken after the recall, was there a specific training at that point to tell operators about the foldover defect, among other things?
A. Yes.
Q. Prior to that time, had they ever been specifically told about the foldover defect?
MR. ZELLERS: Objection. Vague and ambiguous.
THE WITNESS: I'm not aware of.
BY MR. ANGWIN:
Q. What is the defect board?
A. A defect board is a criteria board with assortment of defects that can or may occur during manufacturing. Present in the room for the operators to look at.
Q. Is it like a —
A. Aboard.
Q. — actual pictures?
A. Yes.
Q. And what is — prior to the recall, what was placed on that board, on the defect board related to the Duragesic patch?
A. Seal defects, any kind of defects that is listed on SOP 0502-048. So in majority of those defects, some examples of those assorted defects would be in that criteria board.
Q. Okay. You mentioned SOP 0502-048.
A. Yes.
Q. When was that SOP created?
A. Post recall.
Q. So it couldn't have been there pre recall?
A. No.
Q. Okay.
A. Pre recall was SOP 8900-201.
Q. Right That was — did 0502-048 supercede 8900-201?
A. No. 8900-201 still exists.
Q. Right.
A. The Duragesic portion was taken out and made a separate SOP, so pre recall, those defect will be listed under 8900-201 and displayed in Bodolay 1 room. I'm just saying now it relates to SOP 0205-048.
Q. Yeah. Who Is — what area of responsibility had the responsibility to maintain the — should I call it defect board or criteria board?
A. Either one is fine.
Q. Defect boards.
A. Quality assurance and operations.
Q. That Is not under your area?
A. Would be.
Q. Okay. Was operations underneath manufacturing?
A. Apologize. Manufacturing, production, operations, same thing.
Q. Ultimately that was something that was within your area of responsibility?
A. Yes.
Q. Was there a particular person or group that was responsible underneath you for maintaining the defect boards?
A. My supervisor along with the QA.
Q. What was the criteria for placing different pictures on the defect board prior to the recall?
A. The criteria was to have the critical defect as well as any defect that is known to occur in certain frequency to be listed in there. And that's just my recollection. It may not be exact.
Q. Was the goal to have a picture basically of all known defects so operators could be aware to look out for them?
A. I wouldn't say all known defects, but the defect that may occur in high frequency.
Q. Okay. Which defect occurred with the highest frequency?
MR. ZELLERS: Speculation. Foundation. Overbroad.
THE WITNESS: Any defect that Is caused by registration issues would be there.
BY MR. ANGWIN:
Q. Let me back up. Which system seal breach defect occurred with the most frequency?
MR ZELLERS: Same objection.
BY MR. ANGWIN:
Q. From 2003 forward.
A. Gel in the seal and unsealed channel.
Q. Okay. Would the stringer leaker be the unsealed channel defect that occurred the most often?
A. Yes.
Q. Okay. Is the stringer leaker a defect that is inherent in the operation of the Bodolay machine?
MR. ZELLERS: Objection. Vague and ambiguous. Overbroad.
THE WITNESS: Yes.
BY MR. ANGWIN:
Q. And the stringer leaker is a leading cause of — I think we just had that — of unsealed channels?
A. Yes.
Q. Okay. And am I correct that despite all your efforts that still occurs today? Stringer leakers still occur?
MR. ZELLERS: Speculation. Foundation. Objection.
BY MR. ANGWIN:
Q. If you know. How about this up through January 2006?
A. Pre Vision system in a low frequency, yes. Post Vision system, I don't know the statistics. I want to say zero, but I don't know the statistics.
Q. When you say Vision system, is that production or inspection catching the stringer leakers?
A. The Vision system is a new piece of equipment added to Bodolay 1 to specifically look for system defect.
Q. Okay. Was that an improvement to the Bodolay 1?
A. No, I wouldn't say improvement to the Bodolay 1. I would say it replaced two bodies. Instead of doing manually, you do automatic inspection.
Q. Did you just testify it was better able to detect stringer leakers? Did you just testify that the Vision system is better able to detect stringer leakers than the prior inspection system was?
A. No. I said I don't know the statistics to be able to say that. So pre Vision system installation, I know there was some frequency post. I don't know the data so I couldn't say better or not.
MR. ZELLERS: We are speaking stringer leakers or channel leakers, correct?
THE WITNESS: Yes.
BY MR. ANGWIN:
Q. Is the Vision system an area that you have enough knowledge about to testify about?
A. No.
Q. Okay. Who would be the person who would know more about the Vision system?
A. Process engineering or equipment engineering. More likely equipment engineering but…
Q. Well, we're deposing David Chullino next. Would David Chullino know more about the Vision system than you do?
A. Would know more about it than me.
Q. Let me just ask you, do you know when the Vision system was first considered as an addition to the Bodolay machine, Bodolay 1?
A. No.
Q. I want to go through briefly just a couple of these. I see right there, looking at both pages there are 18, it appears, blocks which deal with corrective action status.
Am I correct that those 18 things would generally refer to actions that were undertaken after the recall to attempt to correct the causes or eliminate a similar problem in the future?
MR. ZELLERS: Objection. Vague and ambiguous.
BY MR. ANGWIN:
Q. Let me ask you this: What are those 18 things about?
A. 18 things —
MR. ZELLERS: Same objection. Go ahead.
THE WITNESS: These are a list of action items performed post recall.
BY MR. ANGWIN:
Q. And what was the purpose of these items?
A. The purpose of the items was to ensure that the quality is maintained or enhanced in Bodolay 1.
Q. It was to try and deal with the cause of the defect is that one?
A. One cause was that. The other thing was — part of it was Mr. Watson requested certain action to be taken before manufacturing can proceed.
Q. Okay. Mr. Watson was the FDA investigator?
A. Yes.
Q. Okay. Lets go just briefly through these.
Number one, which looks like operator training, it says that was completed on 2/20/04?
A. Yes.
Q. Okay. Number two, which is Implementation of a form to document the absence of foldover, looks like that was completed 2/19/04?
A. Yes.
Q. Next one, requirement that QAS operator and production operator verify the absence of foldover upon startup. That was completed 2120104?
A. Yes.
Q. I can go through all of these, but It looks like the first at least seven of those were completed by 2121104; is that correct?
A. Yes.
Q. Is that your understanding?
A. Yes.
Q. And that was within days of the recall?
A. Yes.
Q. Is there any reason those first seven items could not have been done prior to the recall?
MR. ZELLERS: Objection. Vague and ambiguous. Overbroad.
BY MR. ANGWIN:
Q. For example, the — prior to the recall, could the QAS operator have been told to verify the absence of a foldover defect upon startup?
A. They could have, but I believe it — if you look at certain things, certain things were done. When the question is: Do you do this? Yes, we do? Where is the document? We don't document. Mr. Watson says, “No, that's not good enough. I want you to create a form, document, show me.”
So rotation of bombsite operator, that is always done, so it's never documented. So documented.
So most of the things, yeah, we had to document, show it before we can start manufacturing.
Q. Well, if you don't document it, you are just assuming it's done, aren't you? There is no proof it was done.
A. You are right.
Q. And the FDA inspector was insistent that these changes be undertaken before production started back?
A. Yes.
MR. ZELLERS: Overbroad.
BY MR. ANGWIN:
Q. Do you think that's these corrective actions were improvements on the production line?
MR. ZELLERS: Same objection. Vague and ambiguous. Overbroad.
THE WITNESS: I couldn't say that because these were done automatically anyway.
BY MR. ANGWN:
Q. All right Number eight, validation of newly installed Vision system, it says in progress. Do you know, was the Vision system placed on the Bodolay or was — was the Vision system on the Bodolay prior to the recall?
A. No.
Q. Okay. When was the Vision system first placed on the Bodolay?
MR. ZELLERS: Vague and ambiguous as to placed on.
BY MR ANGWIN:
Q. When I say Bodolay, I'm talking about the Bodolay 1.
Was the Vision system — when was the Vision system first Incorporated into or made a part of the Bodolay 1 machine?
A. Sometime after the recall.
Q. Okay. Number four on this list: Requirement for a seal integrity testing every 30 minutes.
A. Yes.
Q. Was that the same testing criteria that was there before the recall?
A. No.
Q. Okay. Is that a — is this a more frequent test?
A. Yes.
Q. Okay. Let's go through these real quickly, the first 18. Tell me which — I know you said some were being done. There was just no form but it was being done.
Which of these 18 had not — was not being done before the recall and was done as a corrective action after the 2004 recall? You can refer by numbers.
MR. ZELLERS: Vague and ambiguous. Objection.
BY MR. ANGWIN:
Q. Do you understand my question?
A. Yes.
Q. Okay.
A. Number two.
Q. Okay.
A. There was no form to document absence of foldover defect as we were not aware that we can manufacture foldover defect.
Q. You weren't aware of it?
A. I was not aware of it.
Q. Okay.
A. Pre recall.
Q. Certainly. Because you weren't told about it, were you?
A. No.
Requirement that QAS operator also look at — when he says absence of foldover defect, I want to clarify they were looking at the film not folding. So an additional check.
Q. Okay.
A. It was always performed by the operators, now the QA was asked to look at it.
Q. Let me ask you to stop you there. Prior to this, there had been no specific instructions that they were supposed to look for — ensure there was not a foldover.
MR. ZELLERS: Objection. Speculation. Foundation.
THE WITNESS: Don't quite understand.
BY MR. ANGWIN:
Q. Am I correct that, because you were not told about the 2001 foldover, that the line production personnel were also not told about the potential for a foldover defect?
MR. ZELLERS: Objection. Speculation.
BY MR. ANGWIN:
Q. Prior to the recall.
MR. ZELLERS: Same objection.
THE WITNESS: I couldn't answer that.
BY MR. ANGWIN:
Q. You could not?
A. No.
Q. But you didn't ever tell anybody because you didn't know about it?
MR. ZELLERS: Objection.
THE WITNESS: True.
BY MR. ANGWIN:
Q. Okay. All right Let's — we've got two more minutes on the tape. Let's go through these — I'm not trying to rush you.
A. That's okay. Seal testing was done, frequency increased.
Q. Which number is that?
A. Number four.
Q. Okay. What was the frequency before that?
A. Twice daily.
Q. It went to every 30 minutes?
A. Yes.
Q. Which is — is that 48 times a day?
A. (Witness nods head).
Q. That's a significant change?
A. Yes.
Q. Okay.
A. Number five, post seal integrity was always performed but it was also performed when you pulled out a system every 30 minutes, and then subsequently changed to every 12 trays because 30 minutes was hard to keep track of.
Q. What had been the requirement as far as tray checking before that, before the recall?
A. When you say tray checking —
Q. Maybe that's the wrong term, but if you are checking every 12 trays and every 15 minutes, I'm assuming prior to that they — the trays were checked on a different basis?
A. You performed an in-process test. It's a part of in-process test. It approximately comes out to about 25, 30 minutes of production time.
Q. So it's basically they doubled it?
A. Yes.
Q. They tested twice as frequently?
A. Yes.
Q. Okay. I don't want to run out of tape so let's stop there, which is stopping at the end of No. 5; is that correct?
A. Yes.
MR. ANGWIN: Before we go on to No. 6, he needs to change the tape. Thank you, sir.
THE VIDEOGRAPHER: This is the end of videotape number one, Volume I, in the deposition of Sanjay Panda.
The time is 11:31 a.m., and we are off the record.
(Whereupon, a brief recess was taken.)
THE VIDEOGRAPHER: Back on the record. This is the beginning of videotape number two, Volume I, in the deposition of Sanjay Panda. The time is 11:36 a.m. on October 23rd, 2006.
BY MR. ANGWIN:
Q. Mr. Panda, we were going through and you were explaining to me these 18 listed sections here. And I think we had finished No. 5 and we were starting No. 6. If you could please continue.
A. No. 6, QA was requested to double-check that the film is not folded prior to commercial production. Prerecall, this would not be an issue because operators always do that. It was a added assurance step, added.
Rotation of bombsight operators was always done. It was not documented so we requested documents. Validation of the reading system. It would have to occur post implementation of Vision system or installation.
Enhanced lighting for conveyer system. There was the one speculation that the lighting might not be adequate. Upon further review, it was found it was adequate.
Evaluation of system seal integrity and strength dosing device, once again, always been done. We were just requested to evaluate whether the system was okay or not, and it was found okay. Revision of in-process OP 80900201. Like I just mentioned, we used to have that as a defect response SOP. Post recall Duragesic was separated in SOP recall 5020-048.
Q. Let me slow you down for a second here. So SOP, which standard operating procedure 8090201 previously had encompassed defects in all transdermal lines?
A. All products are listed with their defects, possible defects.
Q. And then after the recall, Duragesic was sort of cared out of that and had Its own SOP which is now 0502-048?
A. Yes.
Q. That SOP did not exist before the recall?
A. Yes.
Q. Okay. Thank you. Please continue with No. 12.
A. Implementation of hinge dosing nozzle plate, this occurred post recall but had been already thought pre recall.
Q. Let me ask you, what is the hinged dosing nozzle plate?
A. Okay. On Bodolay 1, to clean the dosing nozzle, you have to take the plate and lay it on the web. During the initial investigation, one school of thought was maybe that process may force the web to fold. So they put a hinge plate so that you just tilt the dosing head instead of putting it on the web, thereby ensuring that the web is untouched.
Q. Was that something that was being looked at prior to the recall?
A. Yes.
Q. Okay.
A. And it was — it's also easier for the operators to clean.
Q. That's fine. No. 13.
A. Installation of web pull wheels. This was an observation made by Mr. Watson and suggested that it may help, and we accommodated that.
Q. Let me ask you: Do you think the installation of wider web pull wheels did help? Help with the reduction or elimination of foldover defects?
MR. ZELLERS: Speculation. Objection.
THE WITNESS: Couldn't say.
BY MR. ANGWIN:
Q. You don't have an opinion?
A. No.
Q. Okay.
A. That wouldn't — it's mainly to help the film guide properly.
Web edge guide position indicators were installed post recall.
Q. Had those been looked at prior to the recall or was that another one of those suggestions from Mr. Watson?
MR. ZELLERS: Speculation. Foundation. Objection.
BY MR. ANGWIN:
Q. If you know.
A. It was not Mr. Watson's suggestions. It was — came from engineering, but I couldn't comment on pre recall.
Q. Okay. 15?
A. 30,000-piece inspection. This was purely done on the lots that were in speculation. This is not a normal practice.
Q. Let me ask you, on the 30,000-piece, was — it's my understanding that was basically a test of 30,000 Duragesic patches going over all tots which — I mean all dosage strengths, which at that time was 25, 50, 75, 100, to determine whether there was a presence of foldover defects.
A. I believe it was all strength and all the lots that were in house to ensure that it's not a prevalent incident and more of an isolated incident to a lot or a specific strength.
Q. Let me ask you that. Sorry to interrupt, but do you have an understanding as to whether foldover defects can occur on any dosage strength other than 75?
MR. ZELLERS: Speculation. Foundation. Objection.
BY MR ANGWIN:
Q. If that's not an area you know about —
A. It is not in my area.
Q. Okay.
A. Training program improvements. Training program always existed and was done at a certain frequency. We were requested to do it even higher frequency. In the wake of recall it's normal thing to ask.
17, Extract system upgrade. Extract is a computer software which QA uses to capture all the investigations of nonconformances during manufacturing.
Q. Let me ask you about the Ex Rx system. Is that a system that creates electronic documents related to problems that occur on the manufacturing process?
A. Any or all problems that occur during manufacturing which will result to a nonconformances are in the Ex Rx system and listed.
Q. Is the Ex Rx, is that paper or is that electronic? How is that stored?
A. It's electronic.
Q. Okay. And how is the information put into the Ex Rx system?
A. The information is manually entered by people who are involved in the investigation. So it would be production, QA, engineering.
Q. Would that be something had you had done?
A. Yes.
Q. Had you actually put information into the Ex Rx system?
A. Yes.
Q. Did you put information into the Ex Rx system with regard to the 2004 recall?
A. Yes.
Q. All right.
A. Bodolay 1 process validation, As a part of implementation of the Vision system, it's normal. It's a requirement to revalidate, and that's No. 18.
Q. When you say revalidate, is that because there had been a change in the machine so you had to basically reprove that the machine properly and safely could manufacture the product?
A. Yes.
Q. Okay. And that goes through all 18 of those. Let me ask you since I touched on that, on the Ex Rx, not only with regard to this and the recall, but did you have any involvement in responding to Mr. Watson's questions or into creating any of the documents that went into the responses that the company made to the EIR?
MR ZELLERS: Objection. Vague and ambiguous. Overbroad. Speculation.
THE WITNESS: I couldn't say about EIR but yes, I input system In the — information into the Ex Rx system.
BY MR. ANGWIN:
Q. When I say EIR, do you know what that term means?
A. I don't know exactly what it means but…
Q. Do you understand that this is the report, the establishment report that was created after the FDA investigation?
A. Yeah. What I meant was I don't know the acronym, what it stands for, but I know the document.
Q. Oak. All right And have you ever seen that document?
A. Yes.
Q. Okay. And were there any specific parts of that document that you were involved In — where were you involved in creating information that is contained In that document?
MR ZELLERS: Vague and ambiguous. Speculation. Foundation.
THE WITNESS: I would have to look at the document to answer that.
BY MR. ANGWIN:
Q. Okay. I'm going to show you a document which Is — looks like a five-page document, DUR 032583 through DUR 0032587, and ask you if you have seen that document before.
A. As far as I recall, I can think of, I have not seen this document.
Q. Okay. Just from its form, does it look like a type of document that would have been contained in any materials that you have seen at Alza?
MR ZELLERS: Speculation, foundation. Objection.
THE WITNESS: Couldn't — wouldn't know.
BY MR. ANGWIN:
Q. Do you know what — it says confidential at the top, for core team use only.
Do you know what the core team refers to?
MR ZELLERS: Speculation. Foundation.
THE WITNESS: No.
BY MR ANGWIN:
Q. All right.
MR. HARVEY: You are objecting to him speculating.
MR. ZELLERS: Yes, yes, yes. It's acknowledged that Mr. Angwin is speculating.
MR. HARVEY: We don't want him to speculate either. If he doesn't know, he can answer that way.
MR. ZELLERS: He has said he doesn't recognize this document, doesn't know —
MR. ANGWIN: I just asked him what the core team was. It sounds like a cool team. I would like to be part of the core team.
Q. This appears to me to discuss form-fill and seal machines used to produce Duragesic. And during the time this refers to February 2002, it states the Bodolay 1 and Klockner were used to produce Duragesic. Was that consistent with your understanding?
A. Yes.
Q. I know that's prior to the time you took over responsibility, though.
And on the second page if you turn over there, down at -looks like the first unfilled circle down there starts with after the Bodolay 1 do you see that?
A. Yes.
Q. Actually, above that. Two spaces above that 200 percent bombsight inspection was added parenthetical, later reduced after the Vision system was qualified en parenthetical do you see that?
A. Yes.
Q. Was there any time you are aware of when the bombsight inspection was increased to 200 percent?
A. I'm a little confused because we always have 200 percent inspection.
Q. Let's talk — when I say bombsight inspection do you know what I refer to?
A. Yes.
Q. What is the bombsight inspection?
A. The bombsight inspection is basically once a system are manufactured and they are die cut, and they are traveling on a conveyer belt to be put inside a pouch, there are two operators standing there monitoring as the system as they go by just to ensure there is no visible defect.
Q. Earlier we had sort of that little diagram that you recall of the assembly process?
A. Yes.
Q. Would that be — where would the bombsight be —
A. Between die cut and package individual system.
Q. That's between what is designated on that document, which is —
A. Three and four.
Q. — Plaintiff's Exhibit 1, as numbers three and number four?
A. Yes.
Q. Okay. Great Okay. My understanding is the bombsight, that is — is that the visual inspection of the product after it leaves the Bodolay machine?
A. No. It still hasn't left the Bodolay machine yet.
Q. I'm sorry. After the product — after the two films are together and the gel is inserted, that's the visual inspection after the die cut?
A. Yes.
Q. So that would be the first time the product is actually a distinct product?
A. Yes.
Q. What is the purpose of that inspection?
A. Just to ensure that it's no gross cosmetic defect or any kind of defect in the system. Basically there should be no defect.
Q. Okay. Would the bombsight inspectors be the first persons to look at the patches after they are cut into distinct individual patches?
A. Depends on whether your question is during manufacturing or premanufacturing because QA and manufacturing would be the first one to look at a complete system.
Q. Well, let's back up and discuss that briefly.
When you distinguish between manufacturing and pre manufacturing, can you tell me what you mean?
A. Pre manufacturing, the equipment is set up, all parameters are verified they are okay.
Systems are made. Those systems are looked at by the operator, the machine operator, lead operator, and showed that they look okay, that meet specification.
Showed it to QA. QA verifies that yes, they meet specification. Your equipment is ready to go. You may proceed to manufacture.
Q. The patches that are produced during that pre manufacturing inspection, are those patches put into commercial production if they are found to be conforming patches?
A. The system that are pulled to inspect are not.
Q. Are those always destroyed regardless?
A. Always destroyed regardless.
Q. So with regard to the patches which ultimately would go to consumer, those are production patches; is that the term we use?
A. Yes.
Q. And for production patches, are the bombsight inspectors the first persons to see those patches after they are cut into individual distinct patches?
A. Answer would be still the same. The QA will still have to look at the production patches once you start manufacturing. Reverify you are okay.
But during manufacturing, when the machine is running, yeah, bombsight is the first person that looks at it.
Q. Are they the only persons that look at the finished patch product before it's put into a pouch?
MR. ZELLERS: Objection. Overbroad. Speculation. Foundation.
BY MR. ANGWIN:
Q. During the manufacturing process?
A. The bombsight would be the only people that look at it, and then all the in-process testing system would be looked by other operators.
Q. And I know there is a sampling plant and in-process. We'll talk about that.
But with regard to, so I understand, not pre manufacturing but when the patch — when the line is up and running and you're making product that will ultimately potentially go to a consumer, when that patch is running, after the patches are cut into individual distinct patches, there are two people that look at them and then —
A. Yes.
Q. — after that, they are put into pouches; is that correct?
A. Yes.
Q. When they are sealed?
A. Yes.
Q. During that process, only two people are actually looking at the patches after they are cut into distinct patches?
A. Yes.
Q. And that's really the — that's the final inspection with regard to the — with regard to the conformance of the patches itself; is that correct?
MR. ZELLERS Objection. Vague and ambiguous.
BY MR. ANGWIN:
Q. Leaving aside in-process testing or sampling.
A. Yes.
Q. Okay. All right. And the bombsight, am I correct that's two personnel at the time?
A. Uh-huh.
Q. Is that yes?
A. Yes.
Q. During the time you were there, it was always two people?
MR. ZELLERS: Objection. Speculation. Foundation.
BY MR. ANGWIN:
Q. I'm sorry. Were there always two people designated to be at the bombsight during production during the time you were the manufacturing supervisor, the production manager for the Duragesic line?
MR. ZELLERS: Objection. Speculation. Foundation.
THE WITNESS: It was my understanding bombsight has been a 200 percent inspection.
BY MR. ANGWIN:
Q. Does that mean two people?
A. Yes.
Q. Those two people, am I correct, stand side by side?
A. Yes.
Q. Which means they're both on one side of the line?
A. Yes.
Q. And when the line is produced, are there — are there two lines of patches coming through the production line? I used the word line twice.
Are there two symptoms side by side that come through at a time on the production line?
A. Yes.
Q. What rate are the patches produced at or were they produced at during the time you were involved with the Duragesic production?
A. 240 systems a minute.
Q. Okay.
A. Approximately. I don't know exactly.
Q. But if the line is running properly, it's approximately 240 patches a minute?
A. Yes.
Q. How long was the bombsight shift during the time you were the production manager?
A. Bombsight-
Q. How long would a person work at the bombsight during a regular shift?
MR. ZELLERS: Speculation. Foundation.
THE WITNESS: As per the document, they are supposed to rotate every 30 minutes.
BY MR. ANGWIN:
Q. Okay. Are you in charge of — were you in charge of personnel, among other things, and proper staffing when you were the production manager for the Duragesic line?
A. Yes.
Q. Would you know how many people were supposed to be on the bombsight at a particular time?
MR. ZELLERS: Speculation. Foundation. Objection.
THE WITNESS: I would think my supervisor would know more. I would be in charge of how many people do you need, do you have adequate people. That would be my answer.
BY MR. ANGWIN:
Q. Who are the supervisors during the 2003/2004 time frame who would have been responsible for bombsight staffing?
A. Laura Branson, Keith Danilson.
Q. Can you spell Danilson?
A. D-A-N-I-L-S-O-N.
Q. Does Laura or Keith still work with Alza?
A. Laura doesn't work for Alza. Keith still works for Alza.
Q. Okay.
A. Mike Tislau.
Q. Spell that, please.
A. M-I-K-E. Last name Tislau. T-I-S-L-A-U. Michael Reyes.
Q. Can you spell that last name, please.
A. R-E-Y-E-S.
Q. Okay.
A. John Dirner, D-I-R-N-E-R. Don Parsons, D-O-N, Parsons, P-A-R-S-O-N-S. Adeline Lowe. Last name L-O-W-E, A-D-E-L-I-N-E.
Q. Does Adeline Lowe also go by another name?
A. Sookling, S-O-O-K-L-I-N-G.
Q. That's the same person?
A. Yes.
Q. Okay.
A. That's what I remember right now.
Q. Okay. When a person was training to become a bombsight inspector, would they undergo the same general type of training that other line production personnel would undergo?
MR ZELLERS: Speculation. Foundation. Objection.
THE WITNESS: I think a supervisor would be able to answer better. I am not close to that so I couldn't tell you.
BY MR. ANGWIN:
Q. Was the bombsight inspector, was that a person that was in that team of nine or ten people you spoke of earlier?
A. Yes.
Q. And during the 12-hour shift, would those people rotate at various jobs on the Bodolay production line?
A. Yes.
Q. And so is — would I be correct that the general training a person undertook to become Bodolay operator would entail how to work as an inspector at the bombsight?
MR. ZELLERS: Objection. Speculation. Foundation. Overbroad.
THE WITNESS: That would be one of their jobs, yes, during entire training course.
BY MR ANGWIN:
Q. And for the on-the-job training part, would that be where they were normally paired with a person who has experience, like a lead person and the lead person would show them how to perform a job?
A. On the OJT, yes.
Q. And during the OJT or on-the-job training, was the — how do we designate the person who's being trained? Could we call them a trainee?
A. The person who is trained is the trainee and the trainer, yes.
Q. Would the trainee be a part of that nine-person team or would he be there In addition, he or she be there in addition to the nine-person team?
MR. ZELLERS: Speculation, foundation. Objection.
THE WITNESS: Couldn't exactly say. Depends on whether there were exactly nine people or there were ten people, so…
BY MR. ANGWIN:
Q. Say there was a nine-person shift and one of those persons was a trainee, would that be —
A. That would be.
Q. Would that be a full shift?
A. Yes
Q. That would be a full team?
A. Yes.
Q. Okay. How many trainees could be on a team? Was there any limit?
A. No.
Q. Could there be as many as two or three trainees on a given team?
MR ZELLERS: Speculation. Foundation. Objection.
THE WITNESS: Like I said, I think the supervisor would be more able to answer that question than me.
BY MR. ANGWIN:
Q. But there was no limit as far as you knew as the director of the production In charge of personnel?
A. I'm not aware of that.
Q. What about temporary workers? Were there temporary workers who sometimes filled in as part of the team of nine or ten people that worked on the Bodolay?
A. Yes.
Q. Where were those temporary workers hired from?
A. Kelly.
Q. Kelly Staffing?
A. Yes.
Q. Okay. Were there any requirements for those temporary workers?
A. Did.
Q. Did they have any engineering background or any expertise or degrees?
MR. ZELLERS: Vague and ambiguous. Overbroad.
THE WITNESS: I couldn't tell you.
BY MR. ANGWIN:
Q. Who would know that?
A. HR or Kelly rep would know.
Q. But as far as you know, In charge of personnel for the production line, you don't know of any specific requirements for the temp person —
A. We would look for past work experience, and pharmaceutical experience would be preferred.
Q. Do you know if you have ever employed, during the time, the approximate three and a half years you were in charge of the Duragesic line, if temporary workers who did not have pharmaceutical or production background were ever employed as workers on the Bodolay 1 production line producing Duragesic patches?
MR. ZELLERS: Vague and ambiguous. Overbroad.
THE WITNESS: I wouldn't know.
BY MR. ANGWIN:
Q. Okay. Do you know about the staffing during the approximate two-week period when the patches Involved in the 2004 recall were produced?
A. Say it again.
Q. Were you — let me ask you this: Were you in charge of the production of the Duragesic line including generally in charge of personnel during the time that the patches involved in the 2004 recall were manufactured?
A. I think they were manufactured during October, so yes.
Q. Okay. And do you know if during the time that those patches were — let me back up. Was there ever any investigation done to determine the time period during which those patches were manufactured?
A. As a part of 200400418, yes.
Q. Did ultimately it come down to there was an understanding that there was an approximately two-week period during which the patches were manufactured?
A. Maybe. I have to look at the log to say yes to that.
Q. Are you aware of any documents relating to the 2004 recall which would indicate that during the time the patches at issue were manufactured, that they were up to three temporary workers working on the Bodolay 1 production line?
A. I'm not aware of that.
Q. Okay. If a temporary worker Is working on the Bodolay 1 production line, during the time you were in charge of personnel, would that include rotating in as an inspector at the bombsight?
MR. ZELLERS: Objection. Speculation. Foundation.
THE WITNESS: I couldn't tell you. It will depend on how the supervisor has laid out the training program. So they are better to answer the question.
BY MR. ANGWIN:
Q. Well, If there were two temporary — let's assume that there is a group of nine people and two temporary workers. Okay?
A. Uh-huh.
Q. Do you know if there Is a way to rotate them so that they don't go onto the bombsight if the bombsight workers are relieved every half hour?
MR ZELLERS: Speculation. Foundation.
THE WITNESS: Once again, I said supervisor would be best suited because it would have additional personnel backing them up or somehow planned logistics so they don't have to do that.
BY MR. ANGWIN:
Q. Well, if there are nine people on the production team, I am assuming they all have a 12:OOPM specific job to do if the production line is operating?
A. Yes and no.
Q. Tell me, yes and no.
A. Nine people are there only because we run through lunches and breaks. So you are freeing up bodies, and that's why you are more than what you need to run the Bodolay.
Q. How many people does it take to operate the Bodolay?
A. Five.
Q. Okay. Was there ever any discussion about more people being needed to operate it?
A. Yes. Once the inspection frequency was improved, we increased the staffing.
Q. To how many?
A. Eleven.
Q. Do you think that was an improvement?
MR. ZELLERS: Objection. Vague and ambiguous. Overbroad..
BY MR ANGWIN:
Q. Do you think the change in staffing made it less likely that defective patches would be produced?
MR. ZELLERS: Same objection.
THE WITNESS: No. We just had to inspect a lot more and had to have bodies to do that.
BY MR. ANGWIN:
Q. When you say inspect a lot more, was that an effort to increase the rate of detection of defective patches?
MR. ZELLERS: Same objections.
THE WITNESS: I wouldn't say necessarily defective patches, but as a part of the recall, we were asked by Mr. Watson to increase the frequency and we did.
BY MR. ANGWIN:
Q. Okay. Mr. Watson is the FDA inspector, correct?
A. Yes.
Q. And when the decision was made to manufacture the 12.5s, the HH machine was chosen?
A. Yes.
Q. Was there a reason for that?
A. Equipment engineering would be able to tell you more, but equipment design of Bodolay 1 did not accommodate the small size.
Q. Okay. When the HH machine was done, was there also an enhanced video inspection system placed on there?
MR. ZELLERS: Speculation. Foundation. Objection.
THE WITNESS: Yes.
BY MR. ANGWIN:
Look at PAGE four of the document in front of you, please. Let me back up.
During the time you were in charge of the production line for Duragesic, are you aware that a video inspection system was placed on the HH machine?
A. Yes.
Q. And was that — was that basically — would that magnify the patches so people could look at them more clearly?
A. Yes.
Q. Was that done to magnify up to four times? If you look at the document, it's there in paragraph two.
A. Yeah, four times.
Q. Okay. And was that so defects could be detected more easily?
MR. ZELLERS: Speculation. Foundation. Objection.
THE WITNESS: The 12 and a half is a very small patch compared to other patches, so yeah.
BY MR. ANGWIN:
Q. Is there any reason that a similar system could not have been put on the Bodolay?
MR. ZELLERS: Same objections.
THE WITNESS: Not that I'm aware of.
BY MR. ANGWIN:
Q. If a similar system had been put on the Bodolay, do you think it would have been — allowed the inspectors to detect defective patches with greater frequency?
MR. ZELLERS: Speculation.
THE WITNESS: Without statistics, I would be speculating.
BY MR. ANGWIN:
Q. You just don't have any opinion on that, do you?
A. (No audible response.)
MR. ZELLERS: Is that no?
THE WITNESS: No.
BY MR. ANGWIN:
Q. What does the term AQL mean?
A. Alza quality limits.
Q. Acceptable quality limits?
A. Yes, acceptable.
Q. I think other industries use them, too.
A. Yes.
Q. I'm not trying to limit you there.
A. No.
Q. Is it your understanding that an AQL or acceptable quality limit is the upper tolerance for a certain type of nonconformity?
A. Yes.
Q. Okay. Would that be a good way to put it?
A. Yeah.
Q. Okay. And within the AQL, prior to the recall, were there different categories that nonconforming patches or detective patches were placed in?
A. Yes.
Q. What were those categories?
A. Critical, major, minor.
Q. After the recall was there another category added or, actually, were the categories changed?
A. Categories were changed.
Q. Was that —
A. Let me go back.
Q. Sure.
A. Category was not changed. The defects, we used to have major A, major B, and then minor. We only had three after that. Major A and major B was taken away. We just had critical, major, minor. We did not have major A, major B anymore. And the defects were reevaluated whether they were in the right category or not.
Q. Was there a reason for that change?
A. I'm not aware of what the reason was, but…
Q. Okay. What is a critical error? I'm sorry, critical defect.
MR. ZELLERS: Vague and ambiguous.
BY MR. ANGWIN:
Q. I'm sorry. Let me back up. Prior to the change after the recall in 2004, what was a critical defect defined as with regard to the Duragesic patch?
MR. ZELLERS: Vague. Ambiguous.
Overbroad. Speculation. Objection.
THE WITNESS: In my understanding, a critical defect Is a defect that could have impact on safety and efficacy If used improperly.
BY MR. ANGWIN:
Q. Could it be a defect that also could cause injury to the ultimate user of the products? Would that fall under the category of critical defect?
A. Yes.
Q. Okay. Do you know what the tolerance for critical defects was for Duragesic patches prior to the recall in 2004?
A. Tolerance has always been zero.
Q. Do you know which would be contained in prior to?
A. 80900201.
Q. Okay. We'll get to that In a moment.
Do you know the numbers for major and minor?
A. Are you talking about AQL tolerances?
Q. AQL tolerances prior to the 2004 recall.
A. No. I would have to look at the document, but I believe it's .065 and .022, something like that.
Q. I'm going to show you a composite document which I think Is most of the investigative report from the 2004 recall, exception reporting system, starting with DUR2, 082463 and going through DUR 082481, and ask you if you can identify that document.
I'm not trying to trick you. I think that's all the pages, but if it is not, the fact that you identified it — and we won't try to trick you on that later. I think that's what was produced.
Does that appear to you to be the exception report?
A. The exception report, yes.
Q. A multipage document. Were you involved in creating any of the information that went into that?
A. Yes.
Q. Okay.
MR. ZELLERS: Let me just state for the record, the — is this the 418 exception report?
MR. ANGWIN: Yeah.
MR. ZELLERS: That report, I believe, is much larger than what we have marked here, so I think this is our excerpts or a portion of that 418 exception report.
MR. ANGWIN: Given — that that's my understanding, too.
Q. This is a portion of it I'm sure —
A. Yes.
Q. — there were other documents that were attached. But you would agree that this is a portion of the 2004 recall exception report?
A. Yes.
Q. Okay.
MR. ANGWIN: We'll mark this collective exhibit as Exhibit 8.
(Whereupon, Exhibit 8 was marked for identification.)
BY MR. ANGWIN:
Q. I'll going to turn your attention, sir, to page DUR2, 082478.
A. Yes.
Q. I'm going to ask you a couple questions about that page.
A. Okay.
Q. I'm sorry, I can't find my other copy so I have to look at it for a moment. Thank you.
The information on that page right there, did you have any involvement In gathering or compiling that information?
A. Yes.
Q. In fact, at the bottom, I see your name; is that correct?
A. Yes.
Q. What Involvement does that indicate to you you had in this?
A. It — that particular term means that I was the one who submitted the investigation. So there can be two instances where you may investigate and submit your own investigation or somebody else provides you the information and you submit it.
Q. Okay. Back up under Investigation, would that be the area that were you involved in?
A. Let me read it to make sure I was the one who investigated it.
Reading this, I don't know if I actually performed the investigation, but yes, I submitted it so I must have been made aware of that or I had a part of this investigation done.
Q. Okay. I'm looking at the second full sentence.
A. Uh-huh.
Q. Actually third full sentence under investigation. Second full sentence says: There are ten operators and one Bodolay-1 team. Do you see that?
A. Yes.
Q. What does the next sentence say, sir?
A. There were three temporary employees assigned to one of the Bodolay 1 night shift team.
Q. Does that indicate to you that there were three temporary workers on a ten-person team?
A. Yes.
Q. Was that acceptable to you back as the production manager for Duragesic in the 2004 time frame?
A. It would depend.
Q. Well, what occurred? Was there any investigation as to why it occurred or was it accepted?
MR. ZELLERS: Objection. Vague and ambiguous.
THE WITNESS: Like I said, it would be more apt for a supervisor to answer. It's mainly saying that every team has a ten-person team and there were three temporary employees assigned.
That does not mean that there were additional employees had not brought up to eight, so that doesn't say that here. I don't know. You have to ask a supervisor.
BY MR. ANGWIN:
Q. Is it your understanding that when temporary workers were hired, that they would then hire additional workers to watch the temporary workers?
MR. ZELLERS: Objection.
MR. ANGWIN: I am trying to understand your past testimony, sir.
MR. ZELLERS: He said talk to a supervisor. Go ahead.
THE WITNESS: I'll repeat, a supervisor will be more apt to answer that question, but it's my understanding that people are brought into the team when you hire somebody to train as part of the training. So that may happen, that may not happen. I couldn't answer that to you.
BY MR. ANGWIN:
Q. Do you know what supervisor would be best to ask about these issues, the issues relating to the 2004 investigation in this particular area that we're talking about?
A. Keith Danilson.
Q. Keith Danilson?
A. Yes.
Q. I'm going down to the next to the last sentence. Starts with: It is highly unlikely.
Do you see that, sir? I think it's the fifth, fourth sentence down.
A. Yes.
Q. It's highly unlikely that there can be two temporary employees assigned to the bombsight at one time.
A. Yes.
Q. Did I read that correctly?
A. Yes.
Q. Does that indicate to you that it's possible that two temporary employees could be assigned to the bombsight at one time, or could have been during this time frame?
MR ZELLERS: Objection.
THE WITNESS: Once again, the supervisor would be best to answer. I would be speculating.
BY MR. ANGWIN:
Q. You just don't know?
A. I don't know.
Q. Okay. Great All right Were there ever any — let's put this back together like that.
A. Okay.
Q. Were there ever any thoughts given to changing the lines speed for the Bodolay 1 production?
A. Yes. Mr. Watson made a request for us to see if that is possible.
Q. Were you Involved In any way in the discussions regarding the potential change in the line speed?
A. I was not involved directly. I heard that that's a request Mr. Watson made. And that engineering evaluation was performed.
Q. I'm going to show you a document that's been produced which is DUR2 042805 through DUR2 042817, and ask you if you have seen that First of all, if you can identify that document.
A. I believe I have seen this document.
Q. If you look on the — let's go, sir, over to page three.
A. Yes.
Q. Is that your signature?
A. Yes.
Q. What date did you sign that document, sir?
A. 3/22/04.
Q. Does that refresh your recollection as to whether you have seen this document?
A. Yes. That's why I said I have seen this document.
Q. What it this document discussing?
A. This document is discussing an evaluation of reducing line speed on Bodolay 1.
Q. Well, why was the reduction in line speed being considered on the Bodolay 17
A. One of the requests Mr. Watson said, can you evaluate if you run it slower? It will run better, or you wouldn't have stringer leakers.
Q. Let's go back to, If you can, background number one on the first page. Am I correct it states: A classic leaker and — I'm sorry. Back to the first.
Gel in the system sealing area can occur as a result of gel buildup on the nozzle during tailing out of the active area into the seal area —
A. Uh-huh.
Q. — during dosing. This Is classified as a classic leaker?
A. Uh-huh.
Q. I'm going to stop reading there for a moment.
Is that the same thing we talked about as a stringer leaker?
A. Yes.
Q. Okay. And continuing with reading:
— and is a critical defect according to SOP 890-0201.
Is that your understanding of what a classic leaker is, a critical defect?
A. Yes.
Q. Okay. What was the tolerance for critical defects?
A. Zero.
Q. Okay. The next sentence, sir, can you read that?
A. At the current line speed, the occurrence of this defect is inherent.
Q. Was it your understanding that at the line speed, during the time that production was occurring prior to the recall, that the occurrence of the classic leaker would occur and was inherent I In the production process?
A. Yes.
Q. Okay. So was there a question whether reduction in line speed could reduce the occurrence of the classic stringer leaker? Is that what this paper is about?
A. Yeah, would we reduce variation in gel dosing if you ran slower.
Q. What — first of all, do you know how the line speed for the Bodolay was initially set?
A. No.
Q. That was there when you got there?
A. Yes.
Q. Can the Bodolay run — the Bodolay 1 run at different line speeds?
MR. ZELLERS: Speculation. Foundation. Objection.
THE WITNESS: Equipment engineering would be best to answer, but I don't know.
BY MR ANGWIN:
Q. Then what was your involvement — I brought this out because you signed it, but what was your involvement in questions about line speed reduction?
A. My involvement would be bringing up to my attention that this is a request being made, we would like line time; so hence, all this ECM will shut down the equipment from this time to this time, do this work. Do you understand or do you agree to allows us to do this ECN?
And I would say “Yes, go ahead and proceed, please.”
Q. That was because you were in charge of the production line?
A. Yes.
Q. Okay. I notice there are a lot of pages here that are — looks like columns that are not filled in.
Do you know If — were these redacted or was this ever done? Do you know if the line speed test was ever — line speed reduction test was ever done?
A. I don't recall all the particulars, but I know it was evaluated and it was found that it could not run less than what line speed it is right now because all the sensors will have to be readjusted and the occurrence of this would actually increase, not decrease.
But Shawn Kertel could probably give you more details than I can.
Q. Can you give me that name again?
A. It is listed on the “prepared by,” first page.
Q. Oh, It says Adeline Lowe, revised by Shawn S-H-A-W-N, K-E-R-T-E-L?
A. Yes.
Q. Shawn or —
A. No. Shawn Kertel could tell you more.
Q. Okay. Shawn Kertel. Who is Shawn Kertel?
A. Equipment engineer.
Q. Okay. Is Shawn — is that a man or a woman?
A. It's a man.
Q. Is he still employed at Alza?
A. Yes.
Q. Okay.
MR. ANGWIN: We'll mark this collectively as Exhibit 9.
(Whereupon, Exhibit 9 was marked for identification.)
MR. ZELLERS: That's Bates numbers 082463 through 082481?
MR. ANGWIN: It's right there.
MR. ZELLERS: So Exhibit 9 is DUR2 042805 through DUR2 042817.
BY MR. ANGWIN:
Q. Did you need to look at that?
A. No.
Q. Okay. Back in the 2003 pre-recall time frame, how many patches of Duragesic were produced per minute when the Bodolay 1 line was running — running properly?
A. Approximately 240.
Q. Okay. Is that the same for each dosage strength?
A. I couldn't say.
Q. Is it your understanding it's about the same? I just don't know. I'm just curious.
A. That's the line speed, but I couldn't tell you.
Q. Okay. And —
A. I don't know.
Q. I think I did the calculation on that. That's like 24 — I forgot, 12,000 — what would that be an hour?
A. 14,400 an hour.
Q. How many of those would a bombsight inspector have to look at in a shift rotation?
MR. ZELLERS: Speculation, foundation. Are you assuming the machine is running non stop for that one-hour period?
BY MR. ANGWIN:
Q. Assuming that for whatever period of time the bombsight inspector is looking there during a normally scheduled shift, how many different Duragesic patches would the bombsight inspector have to look at?
THE WITNESS: As long as they're on duty, they would be looking at everything that is in front of them.
Q. How long was the shift back prior to the recall?
MR. ZELLERS: Objection. Asked and answered.
THE WITNESS: 12 hours.
BY MR. ANGWN:
Q. I'm sorry, how long was a bombsight shift?
MR. ZELLERS: Objection. Asked and answered.
THE WITNESS: A supervisor would tell you more. It's always been my understanding that it's 30 minutes' rotation, so some period. Not 12-hour rotation, but…
BY MR. ANGWIN:
Q. We'll depose — we'll depose those other guys. Can you think of any steps that could have been taken prior to the 2004 recall to lessen or reduce the incidents of classic leakers in the production of Duragesic patches that had not been taken?
MR. ZELLERS: Objection. Speculation. Foundation. Overbroad.
THE WITNESS: I would defer that to process engineering, equipment engineering.
BY MR. ANGWIN:
Q. Okay. Same about the foldover?
A. Was not aware so I couldn't answer that question.
Q. But you would not be the person to answer that question?
A. No.
Q. Okay. Would that be someone in process engineering?
A. Or equipment engineering.
Q. Okay. You testified earlier that when you started to take over transdermals, you transitioned, you went from working on basically 50/50 and then you became basically working 100 percent on Duragesic; Is that correct?
A. Yes.
Q. Was there a reason for that?
A. The then production manager, Mr. Paul Shrock, was transitioning into a new position. And in between him leaving to a new position, us hiring a new person, another production manager for that period of time, I just oversaw the entire department.
Q. Okay. Is overseeing the Duragesic line, is that — I'm assuming that's a full-time job?
MR. ZELLERS: Objection. Speculation. Foundation. Overbroad.
BY MR ANGWN:
Q. During the three years you had it, did that take up all of your work time?
A. If you are asking if the job couldn't be done less time, no, but that is your job so it's your full-time job.
Q. Okay. When the production line is not running, the Duragesic production line, I'm assuming that the patches are not being manufactured.
A. Yes.
Q. In the 2003, last quarter of 2003, was there a high demand for Duragesic patches?
A. There's always been high demand for Duragesic patch. That period, always been high demand.
Q. Well, during the time from October 2003 forward, were — was the Duragesic production line running 24 days — 24 hours a day, seven days a week?
MR. ZELLERS: Objection. Overbroad.
THE WITNESS: As far as I recall, it has always been running 24/7.
BY MR. ANGWIN:
Q. And was — did you ever hear of any concerns that if there was a lack of continued production, that there could be — the Duragesic could go into back order and that order could not be filled?
A. Post recall, yes.
Q. What about pre recall?
A. Pre recall, the only thing I remember is that you — your — theoretically you can make 14,400 a minute, so if the machine is running ideally, you could make more than —
MR ZELLERS: A minute? Did you say a minute?
THE WITNESS: An hour, sorry. If the equipment is running ideally, you could, in a day, make almost 400,000 systems. Normally you only make 150,000 systems.
The question will always be asked: If the equipment can make this much, what are you doing? Why are you making so low? So, yeah, that question always came up: Why is your efficiency so low?
BY MR. ANGWIN:
Q. Who do those questions come from?
A. It would come from the director of manufacturing.
Q. Sorry. Who was that person during the 2003/2004 time frame?
A. Mr. Charlie Bonner.
Q. Okay. And when — did you have conversations with Charlie Bonner about that?
A. About efficiency?
Q. Not about efficiency. I'll get to that, but about the fact that he wanted to — that there was a demand for as much Duragesic as could be produced.
MR. ZELLERS: Objection. Misstates his testimony.
BY MR. ANGWIN:
Q. I'll back up.
A. I couldn't say exact those terms, but I would say more like if you say conversation efficiency, I would say yes.
Q. Was It ever your understanding that the amount of Duragesic being produced was filling demand and that all the patches that were being made were being sold in the marketplace? For example, there was not a warehouse somewhere where there were Duragesic patches sitting.
A. That would be true.
Q. Okay. So every patch that was made went right into, after production, was shipped out and then went relatively shortly into the marketplace and was sold?
MR. ZELLERS: Objection. Vague and ambiguous. Foundation.
THE WITNESS: Well, that would be several months of pipeline, so I wouldn't know exactly every system would automatically ASAP, but in some time period.
BY MR. ANGWIN:
Q. Okay. And is one of the reasons you know that because in 2004, with the recall, there was a shortage of patches?
MR. ZELLERS: Speculation. Foundation. Objection.
THE WITNESS: You could infer that, yes.
BY MR. ANGWIN:
Q. Was there a shortage of patches after the 2004 recall?
A. Yes.
Q. Was there a concern expressed that you were aware of that there would not be enough patches to meet demand?
A. The concern expressed to me that I can think of was we were in a situation where we are not about to have the patients and the patients doesn't have drug. That was biggest concern:
Patients don't have drug.
Q. And that they could go into withdrawal or not be able to control their pain?
A. Not to that detail. Like I said, the only conversation was — I remember was we are in a situation we are we cannot supply our patients.
Q. Would somebody like Charlie Bonner be better equipped to answer those questions?
MR. ANGWIN: Did you want to object?
MR. ZELLERS: This is at the time of the recall; is that correct?
THE WITNESS: Yes.
BY MR. ANGWIN:
Q. Post recall.
A. Right.
Q. Would Charlie Bonner or someone else be better able to answer those questions about if there was — the recall had any effect on the supply and if there was a shortage?
A. Yeah. Somebody in logistics would be, so I would say yes.
Q. Okay.
MR. ANGWIN: Let me take a break for a minute.
THE VIDEOGRAPHER: Going off the record, the time is 12:27 p.m.
(Whereupon, a brief recess was taken.)
THE VIDEOGRAPHER: Back on the record, the time is 12:32 p.m.
BY MR. ANGWIN:
Q. I just have a couple more questions and I will be done.
Mr. Panda, during the time that you were the manager over the Duragesic production line, would I be correct to state that despite your best efforts and despite the inspections, that it was impossible to produce an entire — impossible to produce patches where some of them don't have system seal breaches?
MR. ZELLERS: Ambiguous. Overbroad.
THE WITNESS: impossible would be tough to say because I haven't looked at each and every pouch.
BY MR ANGWIN:
Q. During the time that you were the manager, were system seal breaches produced and did they ultimately get to the marketplace?
A. Yes.
Q. And did that continue on through the entire time that you were the production manager?
A. I would have to look at the consumer complaint database, but major portion, yes.
Q. Okay. And I would assume that If there was a way to have prevented those system seal breaches from occurring, y'all would have done so.
MR. ZELLERS: Objection. Vague and ambiguous. Overbroad. Argumentative.
THE WITNESS: Whenever it was possible, we did.
BY MR. ANGWIN:
Q. You are saying that as the production manager, you took every possible step to ensure that symptoms with seal breaches did not reach the consumer?
MR. ZELLERS: Same objection.
THE WITNESS: Every step that equipment engineering proposed, because I'm not the technical expert, that would help, yes.
BY MR. ANGWIN:
Q. Okay. That would be more of a question — if there were other changes that could have been made, that would be more an engineering question?
A. Yes.
Q. Everything you were told to do, you saw through?
A. Yes.
Q. Great.
MR. ANGWIN: All right. Thank you very much, sir.
THE WITNESS: Thank you.
MR. ZELLERS: Mr. Panda, before we break, I have got just a couple of questions for you following up on Mr. Angwin's questions.
EXAMINATION
BY MR. ZELLERS:
Q. For the pertinent period, you were the Duragesic manager; is that correct?
A. Yes.
Q. And that began as of Q3 of 2003?
A. Yes.
Q. All right And as the manager, did you run the Bodolay machine?
A. No.
Q. Did you train the — let me ask you, who ran the Bodolay machine?
A. The trained operators ran the Bodolay machine.
Q. I have heard lead operator. What is a lead operator?
A. The lead operator is the most expert operator in the line.
Q. Were you involved in terms of training operators?
A. No.
Q. Were you involved in terms of directly supervising operators?
A. No.
Q. Who would be involved in terms of supervising operators?
A. Their team supervisors.
Q. Were you involved in terms of how the nine to ten people were distributed on the Bodolay line during a particular shift?
A. No.
Q. Who would make those decisions?
A. The supervisor and the lead.
Q. Mr. Angwin asked you a question or started to ask you a question: How many patches on average were made by the Bodolay 1 machine back in this time frame, late 03, 2004 time frame?
A. Yes.
Q. And how many, approximately, per day were made?
A. We could make theoretically all the way up to 400,000. Approximately 150,000 were made in a 24-hour period.
Q. Generally, why did the machine — the Bodolay 1 machine only produce 150,000 patches a day when it would have the capacity to produce 400,000 patches a day?
A. Two parts of it. One major reason, which if you are in the pharmaceutical industry, you have to do it. You have to adhere to a quality system and the inspection.
So major portion of the time was spent doing quality inspections, and then there was some line inefficiencies, too, but the majority was cost of quality, which you have to.
Q. Last couple of questions. A foldover defect is what type of breach?
A. It is a seal breach where one side is completely unsealed.
Q. Did you classify that or describe that as an unsealed system breach?
A. Yes.
Q. When did you first become aware of unsealed system breaches?
A. When I took over the position of production manager.
Q. And when was that?
A. 2003.
Q. Okay.
MR. ZELLERS: I have no further questions. Thank you, Counsel.
MR. ANGWIN: I have got two more follow-up.
FURTHER EXAMINATION
BY MR. ANGWIN:
Q. SOP 0502-048 says: Fentanyl FFS in-process inspection and defect response procedure.
A. Yes.
Q. It's my understanding this is sort of a carve-out from SOP 8900-201 to deal specifically with Duragesic?
A. Yes.
Q. Were there also changes that were made to the in-process inspection and direct response procedure that were incorporated Into 048?
A. You mean was that SOP modified more than what was written 8900-201.
Q. Yes.
A. Yes.
Q. Okay. The procedures that are outlined in 0502-048, do they make it more likely that a defect will be found through in-process Inspection than would have been — than — more likely than if it would have been under 8900-201?
MR. ZELLERS: Foundation. Speculation. Objection.
THE WITNESS: No. The criteria was changed so much that we had to make up a new SOP where it is completely outlined what they need to do.
BY MR. ANGWIN:
Q. That was a poorly worded question I did earlier, but was — when the criteria were changed, is the process — the in-process inspection under 048 an Improvement on the inspection process that was done before this SOP was put into place?
A. Yes.
Q. Okay. And could all of the changes that were made, Incorporated into 048, have been made prior to 2003?
MR. ZELLERS: Speculation. Foundation. Overbroad. Objection.
THE WITNESS: I couldn't say that I mean, do you strive for continuous Improvement, so would there have been more changes? Probably changes were done before I came and changes were done in my time period. So I couldn't say that. I would say It's always you strive for changing. It will change probably ten more times.
BY MR. ANGWIN:
Q. As a manager of production, Is there any logistical or production reason that the changes that were made in 048 could not have been made prior to the 2003 time frame?
MR. ZELLERS: Same objections, including overbroad.
THE WITNESS: Just my perspective, as I was not aware of the foldover defect, I couldn't answer that question.
BY MR. ANGWIN:
Q. Okay. Do you know if Janssen manufactures a Fentanyl patch that is not a reservoir patch in any other part of the world?
A. Yes.
Q. Where is that?
A. It's Durogesic, and it's manufactured in Beerse, Belgium.
Q. And that's Durogesic, D-U-R-O-G-E-S-I-C?
A. Yes.
Q. That is a Fentanyl transdermal delivery system?
A. Yes.
Q. That uses the matrix technology?
A. Yes.
Q. Did that replace the reservoir patch in Europe?
MR. ZELLERS: Speculation. Foundation. Objection.
THE WITNESS: I don't know the history.
BY MR. ANGWIN:
Q. Is it the patch that is sold throughout the world except in the United States at this time?
MR. ZELLERS: Same objections.
THE WITNESS: Yes. The patch that was meant for — no, that's — yes.
MR. ANGWIN: Thank you very much, sir.
THE WITNESS: Thank you.
THE VIDEOGRAPHER: This is the end of videotape number two, Volume I, and concludes the deposition of Sanjay Panda.
The time is 12:41 p.m. on October 23rd, 2006, and we are off the record.
(Whereupon, a brief discussion off the record.)
MR. ANGWIN: I had not marked a document which begins with DUR 0032583 and ends with DUR 0032587. We were going to mark that as Exhibit 10.