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BAXTER: MOTION TO STAY 1 IN THE UNITED STATES DISTRICT COURT 3 11 12 TRANSCRIPT OF PROCEEDINGS - MOTION 13 BEFORE THE HONORABLE ROBERT W. GETTLEMAN 14 APPEARANCES: 18 For Baxter Defendants: KIRKLAND & ELLIS LLP 22 23 Official Reporter: JENNIFER S. COSTALES, CRR, RMR 2
1 (Proceedings in open court.) 2 THE CLERK: 08 C 2324, Artemus Banks versus Baxter 3 International; motion to stay. 4 MR. BORTH: Good morning, Judge. 5 Paul Borth on behalf of the plaintiff. 6 MS. PAYNE: Good morning, Your Honor. 7 Christine Payne and Leslie Smith on behalf of Baxter 8 Healthcare and Baxter International. 9 THE COURT: All right. There is two motions, a motion 10 to preserve evidence. Any objection to that? 11 MS. PAYNE: Yes, Your Honor, Baxter objects to the 12 motion for -- 13 THE COURT: Why? 14 MS. PAYNE: Well, Your Honor, Baxter is coordinating 15 with both the FDA, CDC, and foreign ministries to conduct ongoing 16 testing for the root cause of the Heparin issue. So there is a 17 limited number of samples for each particular lot number. And 18 undoubtedly any other plaintiff across the country will be 19 requesting samples for testing as well. 20 Baxter has agreed as plaintiff's counsel acknowledges 21 that we will preserve all of the Heparin, subject to the FDA's 22 ongoing investigation. But because there are multiple 23 plaintiffs, multiple parties at issue, and a limited number of 24 samples for each lot number, it really is something that's going 25 to require MDL-level national coordination to make sure that each 3
1 party gets what they need. 2 THE COURT: Well, that's all well and good. I agree. 3 But why not at least preserve what you've got until that happens? 4 MS. PAYNE: Well, Baxter has agreed to go ahead and 5 preserve everything, and we have expressed that to plaintiff's 6 counsel. The issue is that the testing that is ongoing is 7 destructive testing, meaning that during the test, the product is 8 used up. So to go ahead with -- 9 THE COURT: So some of the sample, some portion of the 10 sample will be destroyed in the testing? 11 MS. PAYNE: Yes, of course. But also a large number -- 12 THE COURT: And those results will be preserved, 13 obviously? 14 MS. PAYNE: Yes, of course. And a large number of the 15 sample will remain available. But to be fair to any other 16 governmental entities that need samples or other plaintiffs, we 17 would just request that the MDL consider this and coordinate on a 18 national level. 19 MR. BORTH: Judge, that becomes the problem, and I think 20 it kind of dovetails with our response to their motion to stay in 21 that this is a biological product, and it has a shelf life. 22 Baxter itself puts a shelf life or expiration date on their 23 product for about a year. 24 Now, some of this, some of this product is expiring as 25 we speak. Different lot numbers have different expiration dates. 4
1 THE COURT: They put expiration dates on aspirin, you 2 know. I don't think they need anything. 3 MR. BORTH: Well, with this, that's where -- 4 THE COURT: Maybe with this drug they do, I don't know. 5 MR. BORTH: Right. In this case, we're not sure yet 6 because of the -- the trouble is with this OSCS, this 7 oversulfated condroitin sulfate that's in the product now, we 8 don't know what effect, if any, that's going to have on this 9 so-called shelf life. Is it going to make it deteriorate faster? 10 Is it going to deteriorate slower? We don't know. 11 And our trouble is that if we stay the proceedings, this 12 product that Baxter is testing may, in fact, expire or somehow be 13 diluted or somehow be compromised so that by the time that the 14 MDL decides where to put this case, hopefully here, by the time 15 we finally get to the product itself to test it with our 16 chemicals -- with our chemists and our experts, the product may 17 be stale. 18 THE COURT: Wait. I saw an MDL panel agenda recently 19 that didn't have this case on it. It had some other Heparin 20 cases on it, but it didn't have this one on it. 21 MR. BORTH: Because we filed it recently, we're going to 22 be a tag along. In fact, we're filing a brief today or tomorrow. 23 THE COURT: So are you on this next agenda then? 24 MR. BORTH: We intend to be on the next agenda to 25 actually -- 5
1 MS. PAYNE: Yes, Your Honor. 2 MR. BORTH: We're in agreement with both defendants that 3 the case should be brought here. 4 But at any rate, our problem is that if this, in fact, 5 does become stale, and the evidence is somehow or it's destroyed 6 -- 7 THE COURT: Are there any other Heparin cases here? 8 MS. PAYNE: Yes, Your Honor. You have the Scott case 9 pending before you, and also there are two other Heparin related 10 cases in the Northern District of Illinois. 11 THE COURT: Which is the lowest number? 12 MR. BORTH: This one. 13 THE COURT: This one? 14 MS. PAYNE: Yes. 15 THE COURT: Lucky me. 16 MR. BORTH: Yes. 17 MS. PAYNE: And Your Honor stayed the proceedings in the 18 Scott case, except for briefing on the motion to remand. Since 19 then Judge Holderman has stayed all proceedings, including 20 briefing on a motion to remand in another case. And Judge Murphy 21 of the Northern District of Georgia has stayed all proceedings, 22 including briefing on a motion to remand. 23 THE COURT: I think the only real complaint that I hear 24 from the plaintiff here is that they don't want any of the 25 product itself to be jeopardized in some fashion. 6
1 MS. PAYNE: Right. 2 THE COURT: And I can't believe that you would object to 3 that either. 4 MS. PAYNE: Well, truly the difference between 5 proceeding in this court and seeking discovery before the MDL is 6 a matter of weeks. The actual expiration date for the lot at 7 issue in this case is October of 2008. 8 Even waiting for the MDL, there is going to be plenty of 9 time for testing. Plaintiff points to no evidence that somehow 10 any sort of contamination is going to affect the shelf life of 11 Heparin. And, in fact, Baxter very conservatively keys its 12 expiration dates so that even at October 2008, it really may not 13 actually be expired. 14 The bottom line is that waiting for the MDL, there will 15 still be plenty of time for testing. 16 MR. BORTH: Also, Judge, this is not the only lot number 17 that's going to be at issue. There is other lot numbers. 18 Obviously this case, that lot number is at issue. We have other 19 cases that we intend to file in the near future once we do our 20 investigation as to the merits of those cases that are going to 21 have varying lot numbers. 22 In addition to that, we don't know what their testing 23 protocol is, so we can't even engage in our own testing to try to 24 make sure that we get the testing performed in advance of any 25 expiration date. And we don't know, again, if the expiration 7
1 date is still valid in light of the fact that this is tainted 2 product. We don't know if that -- and, in fact, we don't even 3 know if it can be preserved by freezing or otherwise, because 4 that may, in fact, jeopardize the integrity of the product itself 5 and then thereby jeopardize our ability to get appropriate 6 testing done and render appropriate results. 7 In addition to that, we don't know the lot numbers that 8 they're testing, we have no idea which ones have been tested, 9 which ones have different levels of OSCS in them. And we don't 10 know if some of our, in fact, some of our clients are going to be 11 affected by a lot number that's found to have a high amount of 12 OSCS, which is this active ingredient in it, that may be 13 compromised by heart or kidney or liver problems, brain problems 14 that we need to know about so that they can get adequate 15 treatment in advance of any of this MDL. 16 MS. PAYNE: Your Honor, the testing procedures as well 17 as testing information is available on the FDA website. I am not 18 -- 19 THE COURT: Let me just stop you. 20 MS. PAYNE: Yes. 21 THE COURT: You are doing testing, and you're 22 coordinating that with the FDA, correct? 23 MS. PAYNE: And other foreign governments, yes. 24 THE COURT: And I assume that the testing you're 25 doing -- I shouldn't assume anything, but I'll assume, tell me if 8
1 I'm wrong -- that the testing you're doing will identify the lot 2 numbers you're testing and the products you're testing, how it is 3 being tested, how the results are being preserved and everything 4 else, and that the FDA is involved with all of that, correct? 5 MS. PAYNE: Correct. 6 THE COURT: And that's available to share with counsel, 7 is it not? 8 MS. PAYNE: The testing information and testing 9 protocols are available on the FDA website, you are correct. 10 MR. BORTH: Well -- 11 THE COURT: Are they? Have you looked? 12 MR. BORTH: I have. As to the protocols, I'm not sure. 13 Baxter has stated in a number, in the Congressional hearings and 14 otherwise that they're conducting their own testing outside of 15 what the FDA is doing. Now, I don't know, I'm not sure since we 16 have no discovery yet what exactly Baxter is doing to test on its 17 own. I know that they're doing testing here in Illinois, and I 18 know they're doing testing in Europe. But I don't know if it's 19 completely in conjunction with the FDA with FDA oversight or 20 they're doing it on their own. 21 THE COURT: Well, let me just ask you, are you doing it 22 on your own in addition to what you are doing with FDA oversight? 23 MS. PAYNE: Baxter is coordinating with the FDA. The 24 FDA has asked Baxter to conduct its own testing. However, we are 25 following the FDA protocols. 9
1 THE COURT: All right. Here is what I think you should 2 do. I don't think you're too far apart in your mutual positions 3 here. I respect what the plaintiff is concerned about, because 4 they want to make sure that this stuff is preserved or at least 5 the results of the testing are preserved. 6 And you want to go ahead with this ongoing program, 7 which is important, because there are people out there who are 8 affected by it. It will certainly affect the litigation. But 9 more importantly, it will affect the people who are taking this 10 stuff. 11 So what I think you should do is share -- I'm in favor 12 of staying litigating on the traditional level until the MDL 13 makes its decision, because it should be coordinated. 14 On the other hand, I'm also convinced, and I think it 15 makes perfect sense that everything should be preserved that is 16 not being somehow altered in the testing process, and that the 17 protocols that you're following, the lots that you're testing and 18 all of the other testing information should be shared at this 19 point. And that's where we should leave it until the MDL panel 20 decides where to put this case. If it's here, then I'll have to 21 coordinate everything. If it's not, somebody else will. 22 So what I would like to see from you is some sort of 23 agreement to share information that satisfies the plaintiff's 24 counsel that they're getting -- that they know what is going on 25 and that they don't have a problem with it, but that it shouldn't 10
1 stop what's going on with some sort of traditional preservation 2 order that, you know, that we usually enter in a case like this 3 if it's a one-on-one case. This has got a lot greater 4 implications than that. 5 So what I am going to do is continue this for a short 6 time, both of these motions. And I'd like you to see if you can 7 work some sort of an agreed order out that accomplishes the goals 8 that I just articulated, probably not in as good a form as I'd 9 like, but I think you understand what I'm saying. 10 MR. BORTH: Yes, Judge. 11 THE COURT: You both agree with that? 12 MR. BORTH: Yes. 13 MS. PAYNE: Yes. Baxter agrees to preserve all of the 14 Heparin subject to the testing needs of the foreign -- 15 THE COURT: I wouldn't want to find out, no judge would, 16 later on that something was taken, you know, out of play that 17 should have been kept in play at this point. 18 MR. BORTH: And that's in keeping, too, with -- our 19 objective here is not to engage in widespread discovery, but it's 20 more limited as you've stated to preservation of this. And the 21 data that we're getting, because we do need to conduct our own 22 independent testing on their -- 23 THE COURT: Sure. 24 MR. BORTH: We're not bound by their results. 25 THE COURT: No. But I assume that whatever they're 11
1 doing will be subject to scrutiny later on by, not just you, but 2 other plaintiffs. 3 MR. BORTH: Of course. 4 THE COURT: Other litigation. 5 MR. BORTH: Of course. 6 THE COURT: And the government as well. 7 MR. BORTH: Right. 8 THE COURT: I mean, this is just the tip of this very 9 large iceberg we're dealing with. 10 MR. BORTH: It is. 11 THE COURT: So why don't you folks see if you can get an 12 agreed order that deals with both of these related motions and 13 come back in a week or so. And if you can't solve it, then I'll 14 just have to make a decision obviously. 15 MR. BORTH: That's fine, Judge. We're agreeable to 16 that. 17 THE COURT: Why don't we say the 15th at 9:30 -- I'm 18 sorry, I'm looking at the wrong week. The 22nd at 9:30. 19 MS. PAYNE: 9:30, did you say? 20 THE COURT: Yes. 21 MR. BORTH: That's fine, Judge. 22 MS. PAYNE: Thank you. 23 MR. BORTH: Thank you. 24 THE COURT: Okay. I'll see you then. You know, if you 25 work out an agreed order of some type, drop it off before that. 12
1 MR. BORTH: Sure. 2 THE COURT: So I can take a look at it. 3 MR. BORTH: Of course. Thank you, Judge. 4 THE COURT: See you then. 5 (Whereupon the Court heard other matters on his call.) 6 MR. BORTH: Can we step up for a moment? 7 THE COURT: Sure. That didn't take long. 8 MR. BORTH: No, it didn't. 9 MS. SMITH: I'm confident that we're going to be able to 10 work it out. We just want to make sure we understand what Your 11 Honor is focused on. 12 MR. BORTH: We were just trying to discuss some of the 13 initial parameters before we get into real discussions. 14 THE COURT: Let me find my notes here. Hold on. 15 MR. BORTH: Sure. 16 THE COURT: Here it is. Okay. 17 MR. BORTH: One of the issues that we are disagreeing 18 about here is that the Court indicated that the protocol should 19 be shared as well as the testing results should be shared at this 20 time. And that's where, I guess that's essentially -- 21 THE COURT: Why wouldn't you? They're going to have to 22 be shared eventually. 23 MS. SMITH: It's not that I have an objection to share 24 the testing results. I came here today understanding that what 25 was at issue was preservation as requested in their motion. 13
1 THE COURT: Well, there is also -- wait a minute. There 2 is also request to stay the litigation generally. 3 MS. SMITH: Right. Again, we're preserving everything. 4 That's not the issue. The issue, Your Honor, is that there are 5 two questions: Are we going to provide the protocols? Which we 6 will. Or are we preserving everything? Yes, we will. Will we 7 be able to work out I believe an order that is consistent with 8 Your Honor's goals of, you know, preserving everything until a 9 broader preservation order is entered by whatever court might be 10 designated by the MDL panel? 11 What is of concern to me is that plaintiff's counsel 12 has, you know, they say a hundred potential claims, and they're 13 trying to sort through those claims and trying to get information 14 about testing results so that they know what to do with those 15 claims. And I am separately willing to engage in discussions 16 with them about that, because I think it could be productive. 17 But I don't -- I didn't understand Your Honor to be 18 ordering some kind of full-scale production so that they can sort 19 through a hundred claims and decide which ones to bring and which 20 ones not to. 21 THE COURT: I don't understand what you mean by 22 "claims." 23 MR. BORTH: We have a number of -- this one lawsuit is 24 just, is the first of our lawsuits. 25 MS. SMITH: One person, right. 14
1 MR. BORTH: We have about a hundred other cases that are 2 in the process of being worked through. 3 MS. SMITH: That aren't filed. 4 MR. BORTH: That's not entirely the issue here though, 5 is that the testing results that they already have, I don't see 6 why that's a problem to provide those testing results to us to 7 identify lot numbers that they have tested. In some respects it 8 helps us to determine the nature and extent of a protective order 9 or preservation of evidence order in that we know that certain 10 lots were tested. We know how much of the particular product was 11 used up. 12 THE COURT: What form did the test results take? Are 13 they just computer generated? 14 MS. SMITH: There are a number of different tests, Your 15 Honor. There are spectrographic tests in which, you know, it's a 16 computer, you see the comparison. There were also, for example, 17 MIT did animal testing, Baxter has done animal testing. I mean, 18 there are so many different tests that have been undertaken. 19 And my only concern, I want to be perfectly clear, 20 Baxter obviously has no objection to preservation. There is no 21 issue there. What I became concerned about is trying to broaden 22 what Your Honor said into getting broader discovery for the 23 purpose of sorting through potential clients. 24 I'm willing to engage in those discussions, but I don't 25 think it should be part of the preservation order that Your Honor 15
1 asked us to work out, which was set for the specific purpose of 2 making sure that everything stays in play while we -- until the 3 MDL court coordinates the whole thing. 4 MR. BORTH: I think where counsel is going here is that 5 this is not -- she's trying to pigeonhole this into strictly a 6 preservation of evidence motion, where we're opposing the motion 7 to stay in that we just want limited discovery, if you will, 8 that's got preservation of evidence, give us the protocols, give 9 us the test results that are already in play, which is just a 10 matter of paper that's not going to be in any way prejudicial to 11 them, especially in light of the fact that a number of these 12 cases have already been stayed, which I think it counters their 13 own argument that they're going to have to produce this to 14 everybody. They can produce it to those who haven't been stayed, 15 but I don't see what the problem is in producing test results 16 which will aid us in making sure that we know that our clients 17 are properly managed with their healthcare. 18 In the event that one of our clients has taken the OSCS 19 product, which we don't know yet because the testing results are 20 in their hands, we need to make sure that our clients are getting 21 the appropriate medical care to counteract whatever adverse 22 events occur. 23 So there is a health issue here as well as a discovery 24 issue. And they obviously, they have said a number of times here 25 that they're not objecting to providing it, they just don't want 16
1 to do it now. 2 MS. SMITH: I'm sorry. I do object to discovery. What 3 I don't object to is preservation in a form that gives Your Honor 4 the assurances that you were looking for. But I do think what 5 they're looking for is discovery, which is exactly what ought to 6 be postponed, not only because of the MDL, but general Rule 26 7 standards in terms of what they are going for. I don't think 8 it's appropriate at this stage to engage in that scope, 9 particularly when what is really at issue are people who aren't 10 even in this case. 11 So I feel comfortable that we'll be able to work out a 12 preservation order that meets the concerns Your Honor 13 articulated. But I did want to say that we do object to 14 discovery. 15 THE COURT: I think Baxter is correct here. If you 16 start disclosing immediately the test results for, let's say the 17 lot numbers involved in this case, you're basically getting early 18 discovery in this case. That doesn't bother me as much, because 19 it's there. It's easy enough to disclose. 20 But if there is test results for other lot numbers for 21 non-plaintiffs in this case, then you're getting basically 22 multidistrict discovery before there is a multidistrict action 23 even certified by the panel. 24 And I just think procedurally that is rushing things a 25 bit. It's going to happen. So all of those results -- the order 17
1 should reflect that all test results, all lot numbers, all actual 2 samples possessed by or controlled by the defendants, all 3 defendants -- I mean, you're just representing Baxter, right? 4 MS. SMITH: Yes, Your Honor. 5 THE COURT: So, I mean, I don't know, where are the 6 other defendants in this case? 7 MR. BORTH: They haven't -- to my knowledge, SPL has not 8 appeared yet. I have not received any -- 9 MS. SMITH: Has SPL been served in this case? 10 MR. BORTH: I'm not sure. I thought they were served, 11 but I'm not sure about whether they have been served. 12 MS. SMITH: I don't believe they have been served. 13 MR. BORTH: Baxter has two -- 14 THE COURT: Well, then they can only agree to Baxter. 15 But all of that possessed or controlled by Baxter must be 16 preserved, you know, completely preserved. And then when the MDL 17 meets -- 18 MS. SMITH: Completely preserved in that the only issue 19 was -- 20 THE COURT: If this goes to another judge or another 21 district, which it may -- I already have an MDL, so they may not 22 give it to me. You know, they sometimes look at that -- 23 MR. BORTH: Sure. 24 THE COURT: -- although we're winding, slowly winding 25 down on that one. But I don't mind taking a second MDL 18
1 particularly. 2 But putting that aside for a moment, whoever gets this 3 is going to want to coordinate with a lot of different plaintiffs 4 and a lot of different plaintiffs' lawyers, no doubt, so that 5 there can be some central discovery and disclosures made. 6 In the meantime, I just want everything in place. You 7 may represent other people who should know about this. But 8 they're not before me now, and I can't rule on their behalf until 9 they are before me. 10 So I think that, you know, if somebody's health or life 11 is in jeopardy here -- 12 MS. SMITH: Baxter would certainly want to -- 13 THE COURT: -- I would convey that to them. You don't 14 need me for that. And they're not going to take any chances. If 15 they do ultimately something that jeopardizes somebody's health 16 or life after such a request is made, there would be hell to pay 17 for it. And I don't think these lawyers or this company is going 18 to be putting themselves in that position. But that's an 19 extrajudicial comment that I think is probably unnecessary. 20 MR. BORTH: Judge, so as to the test results, just to 21 clarify where we're going here, can we get the test results as to 22 our lot numbers? 23 THE COURT: Yes, I think that's fair enough. That's 24 sort of a trade-off. Even though you're getting some early 25 discovery for your case, I think that's a good trade-off for 19
1 agreeing to hold everything else off now. 2 MR. BORTH: Again, I do think that it would be 3 productive in that not just early discovery, but it will also 4 give us some guidance as to what -- we don't know what their 5 testing protocol is. We don't know what they have done with the 6 particular product and the lot number. If there is any lot, we 7 don't know, so that's -- 8 THE COURT: You should make a lot of these points to the 9 panel that expedition here is an important, because there are 10 health concerns, you know, people out there. 11 MR. BORTH: Yes. And we are, we are, Judge. 12 THE COURT: I'm sure they'll be responsive to that. 13 MS. SMITH: Thank you, Your Honor. 14 THE COURT: Good luck. So I hope that gave you -- 15 MS. SMITH: It does. I believe we'll be able to work 16 something out, I'm sure. Thank you. 17 THE COURT: All right. 18 (Proceedings concluded.) 19 C E R T I F I C A T E 20 Next: Reporting Heparin Problems For information on the recall, click here: To contact us, call 800-992-9447. Gordon Johnson is the Owner of the Johnson Law Office. ©Gordon S. Johnson, Jr. 2008 |
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