Pocztowski v. Ethicon, Inc. et alMOTIONS.D.W. Va.July 8, 2016UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF WEST VIRGINIA AT CHARLESTON IN RE ETHICON, INC., PELVIC REPAIR SYSTEM PRODUCTS LIABILITY LITIGATION Master File No. 2:12-MD-02327 MDL 2327 JOSEPH R. GOODWIN U.S. DISTRICT JUDGE THIS DOCUMENT RELATES TO: Debra Pocztowski v. Ethicon, Inc. et al. Case No. 2:12-cv-01470 DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT Defendants Ethicon, Inc., Ethicon, LLC, and Johnson & Johnson (collectively, “Ethicon”), pursuant to Federal Rule of Civil Procedure 56, move for summary judgment on all of Plaintiff Debra Pocztowski’s claims. In support of this motion, Ethicon states: 1. Plaintiff’s personal injury claims sounding in negligence (Counts I (negligence), X (negligent infliction of emotional distress), and XIV (gross negligence)) and strict liability (Counts II (manufacturing defect), III (failure to warn), IV (defective product), V (design defect)) are barred by Illinois’ two-year statute of limitations. Equitable tolling and fraudulent concealment (Count XVII) do not preserve the timeliness of Plaintiff’s claims. 2. In addition to being time-barred, Plaintiff’s strict liability claims (Counts II (manufacturing defect), III (failure to warn), IV (defective product), and V (design defect)) fail as a matter of law on the merits because she cannot establish the essential elements of these claims. 3. In addition to being time-barred, Plaintiff’s negligence-based claims (Counts I, X, and XIV) by necessity fail because they are based on the same series of facts as her strict liability Case 2:12-cv-01470 Document 62 Filed 07/08/16 Page 1 of 5 PageID #: 586 2 claims. Because they are duplicative of the strict liability claims, but require additional proof of fault, summary judgment is also proper as to Plaintiff’s negligence claims. 4. Plaintiff’s warranty and fraud-based claims (Counts VI (fraud), VII (fraudulent concealment), VIII (constructive fraud), IX (negligent misrepresentation), XI (breach of express warranty), XII (breach of implied warranty), XIII (consumer fraud), and XV (unjust enrichment)), are improperly re-packaged failure to warn claims; and thus should be dismissed as subsumed by that claim. 5. Additionally, Plaintiff’s warranty and fraud-based claims (Counts VI, VII, VIII, IX, X, XI, XIII, and XV) fail on the merits. Plaintiff presented no evidence sufficient to satisfy the necessary elements of her claims. There is no genuine issue of material fact for trial on these claims. 6. Ethicon incorporates by reference its Memorandum in Support of its Motion for Summary Judgment and the following exhibits: Exhibit Description A Excerpts of Debra Pocztowski 4/7/16 Deposition Transcript. B Excerpts of Michael Noone, M.D. 5/5/16 Deposition Transcript. C Redacted 5/12/04 Medical Record. D Redacted 9/20/06 Medical Record. E Redacted Plaintiff Profile Form. F Redacted 1/31/07 Medical Record. G Redacted 3/10/99 Medical Record. H Redacted 3/18/99 Medical Record. I Excerpts of Bruce A. Rosenzweig, M.D. 5/26/16 Deposition Transcript. Case 2:12-cv-01470 Document 62 Filed 07/08/16 Page 2 of 5 PageID #: 587 3 Exhibit Description J 12/6/04 Medical Record. K Redacted Plaintiff Fact Sheet. WHEREFORE, FOR THESE REASONS and as more fully set forth in Ethicon’s supporting memorandum of law, Ethicon respectfully requests that this Court enter an order granting Ethicon’s Motion for Summary Judgment and dismissing all of Plaintiff’s claims with prejudice. Dated: July 8, 2016 Respectfully submitted, /s/ Tarek Ismail Tarek Ismail Andrew L. Goldman Joe W. Tomaselli Shayna S. Cook GOLDMAN ISMAIL TOMASELLI BRENNAN & BAUM LLP 564 West Randolph Street, Suite 400 Chicago, IL 60661 (312) 681-6000 (312) 881-5191 (fax) tismail@goldmanismail.com agoldman@goldmanismail.com jtomaselli@goldmanismail.com scook@goldmanismail.com /s/ Christy D. Jones Christy D. Jones BUTLER SNOW LLP 1020 Highland Colony Parkway Suite 1400 (39157) P.O. Box 6010 Ridgeland, MS 39158 (601) 985-4523 christy.jones@butlersnow.com /s/ David B. Thomas David B. Thomas (W.Va. Bar #3731) Case 2:12-cv-01470 Document 62 Filed 07/08/16 Page 3 of 5 PageID #: 588 4 THOMAS COMBS & SPANN PLLC 300 Summers Street Suite 1380 (25301) P.O. Box 3824 Charleston, WV 25338 (304) 414-1807 dthomas@tcspllc.com COUNSEL FOR ETHICON, INC., ETHICON, LLC, AND JOHNSON & JOHNSON Case 2:12-cv-01470 Document 62 Filed 07/08/16 Page 4 of 5 PageID #: 589 5 CERTIFICATE OF SERVICE I hereby certify that on July 8, 2016, I electronically filed the foregoing document with the Clerk of the Court using the CM/ECF system which will send notification of such filing to CM/ECF participants registered to receive service in this MDL. /s/ Tarek Ismail Case 2:12-cv-01470 Document 62 Filed 07/08/16 Page 5 of 5 PageID #: 590 EXHIBIT A Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 1 of 28 PageID #: 591 Debra Pocztowski Golkow Technologies, Inc. Page 1 1 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF WEST VIRGINIA 2 AT CHARLESTON 3 IN RE: ETHICON, INC., ) MDL NO. 2327 PELVIC REPAIR SYSTEM ) 4 PRODUCTS LIABILITY ) JOSEPH R. GOODWIN LITIGATION ) U.S. DISTRICT JUDGE 5 ) -----------------------------) 6 ) THIS DOCUMENT RELATES TO: ) 7 ) Debra Poczkowski v. ) 8 Ethicon, Inc., et al. ) ) 9 Case No. 2:12-cv-01470 ) ) 10 -----------------------------) 11 12 The video-recorded deposition of 13 DEBRA POCZTOWSKI taken before Pauline M. Vargo, an 14 Illinois Certified Shorthand Reporter, C.S.R. 15 No. 84-1573, at the offices of Goldman Ismail 16 Tomaselli Brennan & Baum, LLP, 564 West Randolph 17 Street, Suite 400, Chicago, Illinois, on 18 April 7, 2016, at 9:58 a.m. 19 20 21 22 23 GOLKOW TECHNOLOGIES, INC. 877.370.3377 ph | 917.591.5672 fax 24 Deps@golkow.com Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 2 of 28 PageID #: 592 Debra Pocztowski Golkow Technologies, Inc. Page 27 1 MR. KEITH: I object to form. 2 A. Yes. 3 Q. Are you aware of any other type of mesh 4 that you received other than TVT? 5 A. No. 6 Q. To make things simpler for this 7 deposition, if it's okay with you, I will refer to 8 the TVT as simply mesh; is that okay? 9 A. That works for me. 10 Q. You will know what I'm referring to? 11 A. Right. I -- yeah. 12 Q. What injuries are you claiming that the 13 TVT mesh caused you? 14 A. I have pelvic pain. It's like having 15 menstrual cramps all the time. I have reoccurring 16 UTIs and bladder infections that I take a 17 suppressor med for, which is what the Cipro is for; 18 discomfort with physical intimacy; and those are 19 the -- the high points. 20 Q. Other than pelvic pain, recurring 21 urinary tract infections and bladder infections and 22 discomfort with physical intimacy -- are you 23 referring to sexual intercourse? 24 A. Yes. Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 3 of 28 PageID #: 593 Debra Pocztowski Golkow Technologies, Inc. Page 28 1 Q. Other than those three categories of 2 injuries, is there any other injury that you claim 3 that mesh caused you? 4 A. That's really the highlights, yes. 5 Q. Is that all you can think of right now? 6 A. Right now, yeah. 7 Q. When did you first experience pelvic 8 pain that you believe is related to your mesh 9 implant? 10 A. I don't recall. It was -- I have to 11 think. It was probably about nine months, six to 12 nine months after. I had -- well, the pelvic pain, 13 probably about a year afterwards, year and a half 14 afterwards. 15 Q. So sometime in 2005? 16 A. Yeah, yeah. I don't know if it was 17 2005. 18 Q. Or early 2006? 19 A. Yeah, something. I really -- it's a 20 hard recall. 21 Q. Can you tell me a little bit about when 22 you first noticed the pelvic pain following your 23 mesh surgery in May of 2004? 24 A. I really don't. Boy, these are dates Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 4 of 28 PageID #: 594 Debra Pocztowski Golkow Technologies, Inc. Page 33 1 were being asked for. I didn't have recollection 2 of exact dates, so that's why I said look to the 3 medical. I know that everybody would have my 4 medical records. 5 Q. And so you would defer to what your 6 medical records say as far as the precise dates of 7 injuries you are claiming; true? 8 A. Yes, I would say so. 9 Q. Has any healthcare provider ever told 10 you that the pelvic pain, recurring UTIs and 11 bladder infections or the sexual pain, intercourse 12 -- pain with sexual intercourse, that any of those 13 injuries are due to your mesh implant? 14 A. No, they have not. 15 Q. Did you ever receive medical attention 16 for the discomfort that you testified you 17 experienced back in 2006 with sexual intercourse? 18 A. No. 19 Q. So you have never seen a physician about 20 any sexual intercourse pain in regards to your 21 mesh, correct? 22 A. Once the relationship ended and I wasn't 23 pursuing that, I did not -- you know, I told the 24 doctor I had it when I went for my physicals, but Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 5 of 28 PageID #: 595 Debra Pocztowski Golkow Technologies, Inc. Page 41 1 until you are blue in the face, and you are not 2 going to stop. It's just a puddle. I wear dark 3 clothes because if I do have an accident, it's 4 hidden until I can get situated. 5 Q. And for urge incontinence, that's a 6 problem that you suffered from both before and 7 after your mesh surgery, correct? 8 A. No. Well, there is a difference between 9 the two. There is the incontinence and the urge 10 that I had beforehand, which was the leaky faucet, 11 to what occurs now I know is really urgent because 12 it is not a leaky faucet; it is turned on full 13 force and I have no control. 14 And I have grandchildren. I have to go 15 to a park, not their favorite one, but I have to go 16 to the one closest to their home or my home, 17 whichever place we are at, so I could be close to a 18 bathroom; and it's really hard to explain to your 19 four-year-old granddaughter that you wet your 20 pants, and I've had to do that, so... 21 Q. Has any healthcare provider ever 22 indicated to you that the urge incontinence 23 problems you have is because of your mesh implant? 24 A. No. Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 6 of 28 PageID #: 596 Debra Pocztowski Golkow Technologies, Inc. Page 43 1 that you received back in May of 2004 would not 2 address urge incontinence, correct? 3 A. I don't really recall if I understood 4 that at the time. 5 Q. Did you know that mesh -- did you know 6 that the mesh TVT that you received is indicated to 7 treat stress urinary incontinence but not urge 8 incontinence? Did you know that? 9 A. No, I did not. 10 Q. Your doctor, Dr. Noone, never told you 11 that? 12 MR. KEITH: I object to the form. 13 A. He may have, but I really don't recall. 14 Q. Would you defer to medical records 15 indicating -- 16 A. Yeah, probably. 17 Q. So, if medical records indicate that 18 Dr. Noone told you before your May 2004 mesh 19 surgery that the implant would address your stress 20 urinary incontinence but not your urge 21 incontinence, you would defer to those records; 22 true? 23 A. I'm not sure I would, because this was a 24 secondary surgery. The reason I was having surgery Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 7 of 28 PageID #: 597 Debra Pocztowski Golkow Technologies, Inc. Page 44 1 primarily was because I had a -- I was bleeding, I 2 was non-stop bleeding. I was going in for a total 3 hysterectomy. This was a secondary surgery that I 4 was having. It wasn't the primary reason for my 5 surgery. The primary reason was my hysterectomy. 6 There was no way out of it. I was trying to kill 7 two birds with one stone and figured, okay, we will 8 throw this in too and get this done. 9 I had been sick for a very long time 10 with the bleeding, like 3, 3-1/2 months. I don't 11 recall exactly. So, they may have and they may 12 have not. I really don't recall. It was a very 13 hard time in my life. I was truly struggling 14 physically. 15 Q. And so the May 2004 surgery, you bring 16 up a good point, the surgery was not just to 17 implant a TVT; is that right? 18 A. It was for my hysterectomy as well, 19 total. 20 Q. And the hysterectomy that you received 21 in May of 2004 was to address the abnormal bleeding 22 that you were experiencing? 23 A. Yes. 24 Q. And that condition was troublesome to Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 8 of 28 PageID #: 598 Debra Pocztowski Golkow Technologies, Inc. Page 45 1 you, correct? 2 A. Oh, yes. 3 Q. Did the total hysterectomy address the 4 abnormal bleeding that you were experiencing? 5 A. Yes. 6 Q. Was the mesh TVT, to your understanding, 7 was that intended to address any bleeding problems 8 you were having as of May of 2004? 9 A. I'm sorry. Could you repeat that? 10 Q. You mentioned that there were two 11 different things going on during your May 2004 12 surgery. Was the TVT mesh, to your understanding, 13 was that meant to address the abnormal bleeding? 14 A. No. 15 Q. That was the hysterectomy part of the 16 surgery, right? 17 A. Yes. 18 Q. And then the TVT mesh implant, was it 19 your understanding that that implant was meant to 20 address your stress urinary incontinence? 21 A. The incontinence, yes, the -- yeah, yes. 22 Q. Other than addressing your stress 23 urinary incontinence, was there any other reason 24 that you understood your TVT mesh implant would be Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 9 of 28 PageID #: 599 Debra Pocztowski Golkow Technologies, Inc. Page 52 1 mesh procedure? 2 A. Well, it's been a while since I read it. 3 MR. KEITH: If you can answer her 4 question, answer her question. If you 5 can't -- 6 A. I really can't answer that question. 7 Q. So, sitting here today you have no 8 recollection of Exhibit 3 discussing urge 9 incontinence as a problem caused by mesh; true? 10 A. True. 11 Q. Are you aware of any publication or 12 other piece of literature that identifies urge 13 incontinence as a problem that is caused by TVT 14 mesh? 15 A. No. 16 Q. Has any physician indicated to you that 17 the change in the urge incontinence that you've 18 experienced before and after your mesh procedure 19 are due to your mesh implant? 20 A. No. 21 Q. I take it is -- so, before when we 22 talked about what your worst problem that you 23 attribute to mesh was, you testified under oath 24 that that problem was pelvic pain. Do you recall Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 10 of 28 PageID #: 600 Debra Pocztowski Golkow Technologies, Inc. Page 67 1 Q. Why would -- why would your medical 2 expenses that you attribute to mesh not have been 3 discharged in your 2010 bankruptcy? 4 A. I don't know if I -- they might have 5 been paid. I don't know. I might have had a few, 6 but no, I don't believe so. 7 Q. Any outstanding medical expenses that 8 you had as of 2010, your understanding would be 9 that those would have been discharged in 10 bankruptcy; true? 11 A. Yes. 12 Q. Have you ever spoken with any of your 13 healthcare providers about this lawsuit? 14 A. I do believe I spoke to Dr. Noone, and I 15 went to see him. I don't remember if it was 2013 16 or 2014, but I did ask him, and he told me it had 17 absolutely nothing to do with the mesh, and that's 18 actually the last time I saw him. But he examined 19 me and said no, it has nothing to do with the mesh. 20 Q. So you saw Dr. Noone in either 2013 or 21 2014? 22 A. Yeah, somewhere around there. I don't 23 remember. 24 Q. So somewhere around 2013 and 2014 you Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 11 of 28 PageID #: 601 Debra Pocztowski Golkow Technologies, Inc. Page 68 1 last saw Dr. Noone and he examined you and 2 indicated to you that none of the problems you were 3 experiencing were due to mesh; is that correct? 4 A. That's what he said. 5 Q. Did Dr. Noone comment on your decision 6 to have brought this lawsuit? 7 A. I really don't remember. I told him -- 8 I think I told him. I don't remember the exact 9 conversation, but I was asking him if the mesh 10 could be the issue to some of my problems. I don't 11 remember if I brought up the lawsuit. I may have, 12 but I don't recall the whole conversation. 13 Q. And Dr. Noone indicated that the mesh 14 was not the cause of your problems? 15 A. Yes, he did. 16 Q. Other than Dr. Noone -- withdrawn. 17 Other than having the conversation with 18 Dr. Noone in 2013 or 2014 about your lawsuit, is 19 there any other healthcare provider you've 20 discussed this lawsuit with? 21 A. No. 22 Q. Have you ever received -- withdrawn. 23 Did you ever receive any communications 24 on behalf of an insurance company advising you to Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 12 of 28 PageID #: 602 Debra Pocztowski Golkow Technologies, Inc. Page 104 1 Q. By 1999 you could not walk or run for 2 any length of time without having urine loss; true? 3 A. Yes. 4 Q. By 1999 did you find that you would 5 urinate any time you stretched, coughed, sneezed or 6 did any other kind of physical activity? 7 A. Yes. 8 Q. By 1999 would you go through two to 9 three pads a day due to urine loss? 10 A. Depending on what I was doing, yes. 11 Q. By 1999 do you agree that your urine 12 leakage related to physical activity greatly 13 bothered you? 14 A. It bothered me. It wasn't greatly, but 15 it bothered me. 16 Q. Why would you tell your doctor that your 17 urine leakage related to physical activity greatly 18 bothered you if it wasn't true? 19 MR. KEITH: I object to form. 20 A. I don't know what I said back in 1999. 21 I may have said it, I may not. I don't know. 22 Q. If you said it, it was true; right? 23 MR. KEITH: I object to form. 24 A. There is a difference between 1999 and Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 13 of 28 PageID #: 603 Debra Pocztowski Golkow Technologies, Inc. Page 106 1 know, was I coughing, was I sneezing, was it a 2 brisk walk or, you know, a leisurely walk. There 3 was a difference. 4 Q. Before your May 2004 mesh surgery your 5 stress urinary incontinence problems stopped you 6 from pursuing an active lifestyle; true? 7 A. To a certain degree, yes, yes. Like I 8 said, night and day. 9 Q. Before your May 2004 mesh surgery you 10 had to urinate frequently, correct? 11 A. Yes, I did, and I did that to hopefully 12 prevent leakage. 13 Q. Before your mesh surgery you were going 14 to the bathroom every hour; true? 15 A. I don't remember. That was a long time 16 ago. I really don't recall. 17 Q. Is that consistent with your trying to 18 prevent leakage, going every hour? Does that sound 19 approximately correct as of the time right before 20 your mesh surgery? 21 A. You know, before my mesh surgery, I may 22 have been going to the bathroom more frequently, 23 but I was bleeding. I mean, I was bleeding where I 24 could fill up a pad in 20 minutes. Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 14 of 28 PageID #: 604 Debra Pocztowski Golkow Technologies, Inc. Page 107 1 So, you know, when I think back to that 2 time that's what -- I think more about the fact 3 that I was bleeding so severely that they put me on 4 bedrest two weeks before surgery. 5 You know, so I don't really quite know 6 how to answer that for you. It's not a yes or no. 7 It's depending on the situation, and the 8 circumstances back then were different. This 9 wasn't my primary focus during that time. 10 Q. Before your mesh surgery would you have 11 to get up multiple times during the night to use 12 the bathroom? 13 A. Two to three times, yes. Usually two 14 times. 15 Q. Before your mesh surgery did you ever 16 experience wetting the bed? 17 A. No, unless I was coughing. I mean, if 18 you have a cold or whatever, yes. 19 Q. Before May 2004 did you ever experience 20 urine leakage associated with a feeling of urgency, 21 meaning a strong sensation of needing to go to the 22 bathroom? 23 A. Oh, God, 2004, 2004. I really don't 24 remember, very honestly. Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 15 of 28 PageID #: 605 Debra Pocztowski Golkow Technologies, Inc. Page 108 1 Q. Before your mesh surgery did you ever 2 leak urine when trying to reach the bathroom? 3 A. On occasion, yes. 4 Q. Before your mesh surgery did you ever 5 experience pain during urination? 6 A. I think I had a bladder infection once, 7 and yes, I did have pain. 8 Q. Is Dr. Noone the physician who diagnosed 9 you first with urinary incontinence? 10 A. Yes. 11 Q. And that was back in 1999 or so, right? 12 A. I didn't realize it, yeah. Is that what 13 it says there? Okay. 14 Q. Do you recall if you -- you went to see 15 doctor -- 16 A. I don't know what year it was. 17 MR. KEITH: If you recall, let her 18 know you recall. If you don't recall, let her 19 know you don't recall. It's not a quiz. 20 MS. GREENBLATT: Maybe this will 21 assist. I can go ahead and mark a medical 22 record. 23 (Exhibit 6 was marked for 24 identification as of 4/7/16.) Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 16 of 28 PageID #: 606 Debra Pocztowski Golkow Technologies, Inc. Page 111 1 going through the surgery? 2 A. I just learned to live with it. 3 Q. Did Dr. Noone ever pressure you to have 4 any surgery? 5 A. No. 6 Q. You trusted Dr. Noone's recommendations? 7 A. Yes. I just -- 8 Q. You didn't go forward with the surgery 9 immediately? 10 A. No, I did not. 11 Q. You tried a pessary first? 12 A. Oh, yes. 13 Q. And by your reaction, I take it that the 14 pessary was not a pleasant experience? 15 A. No, it was not. 16 Q. So back in 1999 you did try to use a 17 pessary to address your incontinence? 18 A. Yes. 19 Q. Can you tell me about the problems that 20 you experienced. 21 A. It is just uncomfortable to have it 22 inserted. 23 Q. And so within a few days of getting the 24 pessary you had it removed, right? Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 17 of 28 PageID #: 607 Debra Pocztowski Golkow Technologies, Inc. Page 112 1 A. Yes, if I recall correct. Yeah, I guess 2 so. 3 Q. Prior to May of 2004 did you also try 4 Kegel exercises? 5 A. Yes. 6 Q. Did they work? 7 A. Yes, it helped. 8 Q. Did it help to the point where your 9 stress urinary incontinence was cured? 10 A. No. 11 Q. Before your mesh surgery you were 12 diagnosed with urge incontinence, in other words, a 13 feeling of urgency, needing to go to the 14 bathroom -- 15 A. Um-hmm, yes. 16 Q. -- and having incontinence problems with 17 that; do you recall that? 18 A. Yes. 19 Q. Do you understand that there is a 20 difference between stress urinary incontinence or 21 leakage associated with physical movement and urge 22 incontinence -- 23 A. Yes. 24 Q. -- or leakage associated with the need Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 18 of 28 PageID #: 608 Debra Pocztowski Golkow Technologies, Inc. Page 120 1 yes. 2 Q. And if we could, let's flash forward to 3 May 12th, 2004, the day of your mesh surgery. 4 Okay? 5 A. Um-hmm. 6 Q. Now, you mentioned that you had a total 7 hysterectomy on May 12, 2004, in addition to 8 getting mesh, correct? 9 A. Yes. 10 Q. In addition, you also had both of your 11 ovaries and fallopian tubes removed? 12 A. Yes. 13 Q. And during that same May 12th, 2004 14 surgery you also had a procedure to repair various 15 pelvic floor organs; true? 16 A. I have no idea what they did. If 17 that's -- that's -- I have no idea what they did 18 during surgery. 19 Q. Do you remember any presurgery 20 discussions the day that you underwent your mesh 21 surgery with Dr. Noone or his staff about your mesh 22 procedure? 23 A. I don't recall what was said. 24 (Exhibit 8 was marked for Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 19 of 28 PageID #: 609 Debra Pocztowski Golkow Technologies, Inc. Page 121 1 identification as of 4/7/16.) 2 BY MS. GREENBLATT: 3 Q. You are being handed what's been marked 4 as Exhibit No. 8, and Exhibit No. 8 is a medical 5 record that is dated at the bottom right-hand side 6 May 12th, 2004, and do you see that Dr. Noone's 7 signature or Dr. Noone's name also appears at the 8 bottom of this record? 9 A. Yes. 10 Q. Now, prior to your mesh surgery, do you 11 see at the bottom of Page 1 of Exhibit 8 this May 12 12th, 2004 record from Dr. Noone, that Dr. Noone 13 writes here that he told you about various risks 14 that your mesh could cause you; true? 15 A. True -- 16 MR. KEITH: True that he told her or 17 true that it's in this document? 18 BY MS. GREENBLATT: 19 Q. I'm asking whether -- if you 20 understood -- 21 A. You know what? Like I said before, I 22 can't -- I don't remember what exactly was said to 23 me. If he wrote it down, I'm -- but I don't recall 24 what was said to me. I'm sure he read me -- it's Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 20 of 28 PageID #: 610 Debra Pocztowski Golkow Technologies, Inc. Page 122 1 protocol to go over the risks of surgery because 2 all surgery is risky. 3 Q. Do you see on the bottom of Page 1 of 4 Exhibit 8, this May 12, 2004 record from Dr. Noone, 5 that Dr. Noone here writes, "Postoperative 6 dysfunctional voiding, sling erosion, damage to 7 bowel and bladder, surgical complications requiring 8 transfusion or delayed or immediate infections and 9 issues of surgical morbidity and mortality were 10 carefully reviewed. The patient desires to 11 proceed." 12 Did I read that correctly? 13 A. Yeah, you read it correctly. Like I 14 said, I don't recall. 15 Q. If Dr. Noone in fact did provide the 16 information regarding the risk of dysfunctional 17 voiding, sling erosion, damage to bowel and bladder 18 and the rest of the risks that I just read for you, 19 do you believe that you would not have gone forward 20 with your mesh procedure? 21 A. Knowing what I know now, no, I would not 22 have gone forward. 23 Q. Provided the information given at the 24 time, and obviously no one has a crystal ball as Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 21 of 28 PageID #: 611 Debra Pocztowski Golkow Technologies, Inc. Page 123 1 far as what will happen in the future, given the 2 risks that I just read for you, if Dr. Noone in 3 fact did provide those risks to you prior to your 4 mesh surgery, you agreed to those risks; true? 5 MR. KEITH: I object to form. 6 A. I really don't know how to answer it, 7 because I believe Dr. Noone did tell me about risks 8 that were involved. Again, I was very sick at the 9 time, but if he would have told me that there is 10 erosion and bowel issues, I don't think I would 11 have gone through with it, or if he elaborated. 12 I'm sure he warned me. I don't know. I don't 13 remember any of this, very honestly. I don't 14 recall. 15 Q. Did you trust Dr. Noone to evaluate the 16 risks that might apply to your mesh procedure and 17 make a recommendation to you? 18 A. Yes. 19 Q. And did you trust Dr. Noone to recommend 20 an appropriate procedure to address your stress 21 urinary incontinence? 22 A. Yes, of course, I did. I wouldn't have 23 gone through with it if I didn't think he would. 24 Q. Did you decide to have the surgery to Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 22 of 28 PageID #: 612 Debra Pocztowski Golkow Technologies, Inc. Page 124 1 implant TVT mesh based on Dr. Noone's 2 recommendation? 3 A. I did, yes, of course. I did it because 4 I wanted to see if -- I don't know. Yes. I went 5 based on his recommendation. That really is what 6 it all boils down to. 7 Q. Did you get a second opinion prior to 8 going forward with your mesh procedure? 9 A. No, no. 10 Q. Had you ever heard of TVT mesh before 11 Dr. Noone recommended it to you? 12 A. No. 13 Q. Did Dr. Noone discuss any alternatives 14 other than TVT? 15 A. We tried alternatives, the pessary and 16 the different medications. This was, like I said, 17 killing two birds with one stone for me. This 18 wasn't my primary surgery. This was my throw-in. 19 So, maybe I didn't pay enough attention at the 20 time. 21 Q. Do you remember anything else about your 22 conversations with Dr. Noone about your mesh 23 surgery prior to that surgery taking place? 24 A. No. Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 23 of 28 PageID #: 613 Debra Pocztowski Golkow Technologies, Inc. Page 126 1 Q. Did you receive any written information 2 about the TVT mesh before your surgery in May 2004? 3 A. I really don't recall. I may have, but 4 I don't recall. 5 Q. As far as you remember today, did you 6 rely on any information from the manufacturer of 7 the TVT device in deciding to undergo your mesh 8 surgery? 9 A. No. 10 Q. Did you defer to Dr. Noone's 11 recommendation to use the TVT mesh? 12 A. He recommended a bladder lift. You 13 know, you hear mesh and implants. I guess I did 14 defer to him. 15 Q. You didn't do any independent research? 16 A. Well, I went with what I wanted to see 17 happen, the positive side of what this mesh would 18 do, so I was looking at that and I wasn't really 19 looking at the negative, because there were 20 positives that were supposed to occur that didn't, 21 long-term. 22 Q. You trusted Dr. Noone to weigh the risks 23 and benefits for you? 24 A. There is risks and benefits with Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 24 of 28 PageID #: 614 Debra Pocztowski Golkow Technologies, Inc. Page 144 1 A. No, not to my knowledge. 2 Q. Now, if you turn to Page 2 of 3 Exhibit No. 11, this September 2006 record, do you 4 see towards the top under "Plan" reference to doing 5 an examination of your bladder? Do you see that? 6 A. Um-hmm. 7 Q. And this is Dr. Norris who is writing 8 this -- 9 A. Yes. 10 Q. -- this letter, and this is in September 11 of 2006? 12 A. Yes. 13 Q. And he writes that "This bladder 14 examination will allow evaluation of the 15 right-sided flank pain and allow us to assess for 16 incomplete bladder emptying and foreign bodies 17 within the bladder." 18 Do you see that? 19 A. Yes. 20 Q. So, in September of 2006 Dr. Norris had 21 planned to conduct an examination -- 22 A. Cystoscopy. 23 Q. -- a cystoscopy in order to see if you 24 had a foreign body in your bladder, correct? Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 25 of 28 PageID #: 615 Debra Pocztowski Golkow Technologies, Inc. Page 145 1 A. Right. 2 Q. And that was in regards to your urinary 3 tract infections and your flank pain? 4 A. Yes. 5 Q. And that's your stomach pain, pelvic 6 pain? 7 MR. KEITH: I object to form. 8 A. I don't know what "flank" means. 9 Q. Well, do you know where you were 10 experiencing pain in regards to this examination? 11 A. This is a long time ago, and this is 12 when everything started. Things were starting 13 then. 14 Q. And you had had urinary tract infections 15 then, right? 16 A. They were starting, yes. 17 Q. And Dr. Norris was doing an examination 18 to help determine the cause of that? 19 A. I had -- yeah, I guess so. He is a 20 urologist. 21 MR. KEITH: Please don't guess. 22 THE WITNESS: Okay. I apologize. 23 MS. GREENBLATT: Please don't lead. 24 Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 26 of 28 PageID #: 616 Debra Pocztowski Golkow Technologies, Inc. Page 158 1 fixing your hernias? 2 A. That was a -- it's a different kind of 3 hernia, and I can't remember the name of it. I 4 apologize, but yeah, I did have a small day 5 surgery, yes. 6 Q. And that resolved the abdominal 7 discomfort you had had? 8 A. On the right side. The hernias I do 9 believe Dr. Shapiro was talking about are the 10 bigger ones. 11 Q. On the other side? 12 A. Yeah. 13 Q. And you never had surgery on those? 14 A. No. 15 Q. Sorry. My question was bad. Have you 16 ever had surgeries on those left-sided hernias? 17 A. No. 18 Q. Do you currently have a urinary tract 19 infection right now? 20 A. No. 21 Q. When is the last time that you have had 22 a urinary tract infection? 23 A. I don't recall. I really don't recall. 24 It's been a while. Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 27 of 28 PageID #: 617 1 CERTIFICATE OF CERTIFIED SHORTHAND REPORTER 2 I, PAULINE M. VARGO, a Certified Shorthand Reporter of the State of Illinois, 3 C.S.R. No. 84-1573, do hereby certify: 173 4 That previous to the commencement of the examination of the witness, the witness was duly 5 sworn to testify the whole truth concerning the matters herein; 6 That the foregoing deposition transcript 7 was reported stenographically by me and thereafter reduced to typewriting under my personal direction; 8 That the reading and signing of said 9 deposition was reserved by counsel for the respective parties and the witness; 10 That the foregoing constitutes a true 11 record of the testimony given by said witness before this reporter; 12 That I am not a relative, employee, 13 attorney or counsel, nor a relative or employee of such attorney or counsel for any of the parties 14 hereto, nor interested directly or indirectly in the outcome of this action. 15 CERTIFIED TO THIS 19th DAY OF APRIL, 16 A.D. I 2016. 17 18 19 20 21 22 23 24 Case 2:12-cv-01470 Document 62-1 Filed 07/08/16 Page 28 of 28 PageID #: 618 EXHIBIT B Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 1 of 35 PageID #: 619 Michael Noone, M.D. Golkow Technologies, Inc. Page 1 1 IN THE UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF WEST VIRGINIA AT CHARLESTON 2 3 ------------------------- ) IN RE: ETHICON, INC., ) 4 PELVIC REPAIR SYSTEM ) Master File No. PRODUCTS LIABILITY ) 2:12-MD-02327 5 LITIGATION ) ------------------------- ) MDL 2327 6 ) THIS DOCUMENT RELATES TO: ) JOSEPH R. GOODWIN 7 ) U.S. DISTRICT JUDGE Debra Pocztowski v. ) 8 Ethicon, Inc., et al., ) ) 9 Case No. 2:12 cv-01470 ) ) 10 ------------------------- ) 11 12 The videotaped deposition of MICHAEL NOONE, M.D., 13 called for examination, taken pursuant to the 14 Federal Rules of Civil Procedure of the United 15 States District Courts pertaining to the taking of 16 depositions, taken before CORINNE T. MARUT, C.S.R. 17 No. 84-1968, Registered Professional Reporter and a 18 Certified Shorthand Reporter of the State of 19 Illinois, at the offices of Advocate Health Care 20 Illinois Urogynecology, Ltd., Suite 665, 1875 21 Dempster Street, Park Ridge, Illinois, on 22 May 5, 2016, commencing at 9:08 a.m. 23 24 Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 2 of 35 PageID #: 620 Michael Noone, M.D. Golkow Technologies, Inc. Page 10 1 BY MR. GOLDMAN: 2 Q. Do you recognize this, Doctor? 3 A. Yes. 4 Q. And what is it? 5 A. It is my CV, my curriculum vitae, a 6 resume. 7 Q. Is Exhibit -- 8 (Clarification requested by the 9 reporter.) 10 BY THE WITNESS: 11 A. A resume would be another term for it. 12 BY MR. GOLDMAN: 13 Q. Is Exhibit 2 a complete and accurate 14 description of your resume? 15 A. Yes. 16 Q. Does it accurately reflect your 17 educational background, your professional 18 experience as a physician, your professional 19 societies and articles, posters that you've written 20 and presented before? 21 A. It does. 22 Q. Dr. Noone, did you attend Georgetown 23 Medical School? 24 A. I did. Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 3 of 35 PageID #: 621 Michael Noone, M.D. Golkow Technologies, Inc. Page 13 1 Chicago Medical School? 2 A. That's a professional title of faculty 3 status and that is active, yes. 4 Q. Can you tell us about your medical 5 practice in general, Dr. Noone, since 2004? 6 A. Since 2004 -- 7 Q. And including 2004. 8 A. We've -- our medical practice has been 9 female pelvic medicine and reconstructive surgery, 10 which is a subspecialty of obstetrics and 11 gynecology that has recently been affirmed board 12 certification. And our practice well before that 13 event has always been pelvic organ prolapse, female 14 bladder dysfunction, pelvic surgery for women. 15 The practice involves treating women 16 with urge incontinence bladder control issues, 17 stress incontinence bladder control issues, pelvic 18 pain related to these conditions as well as 19 defecation and anal control issues. 20 Q. I should have asked you this before, but 21 are you board certified? 22 A. I am. 23 Q. In what? 24 A. Ob-Gyn and in the subspecialty of female Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 4 of 35 PageID #: 622 Michael Noone, M.D. Golkow Technologies, Inc. Page 14 1 pelvic medicine and reconstructive surgery, which 2 is a name for the subspecialty according to the 3 American Board of Medical Specialists. I always 4 like to clarify, typically known as urogynecology. 5 Q. As somebody who specialized in 6 urogynecology over the years, have you treated a 7 condition known as stress urinary incontinence? 8 A. Yes. 9 Q. What is that? 10 A. That is urinary incontinence related to 11 physical exertional stress such as you might have 12 with cough, sneeze or exercise. 13 Q. Would you agree with the fact that it's 14 a condition that often occurs sudden and 15 unintentionally in terms of the release of urine? 16 A. It can, sure. 17 Q. And patients unfortunately who have 18 stress urinary incontinence can have urine 19 discharge during normal everyday activities, right? 20 A. They may, yes. 21 Q. That could include things that are 22 prompted by -- withdrawn. 23 That condition could be prompted by 24 something as minimal as a cough or a sneeze, right? Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 5 of 35 PageID #: 623 Michael Noone, M.D. Golkow Technologies, Inc. Page 25 1 A. I think that's reasonable. 2 Q. Do you continue to implant TVTs with 3 midurethral slings for patients just like 4 Ms. Pocztowski today? 5 A. That type of sling I continue to use. 6 Q. Are there risks associated with all of 7 the surgical procedures that we've mentioned here 8 today, such as the TVT procedure with midurethral 9 slings? 10 A. Yes. 11 Q. The Burch procedure? 12 A. Yes. 13 Q. And the MMK procedure? 14 A. Yes. 15 Q. From the time you first started 16 performing surgeries on patients with stress 17 urinary incontinence, sir, have you always known 18 that any of those surgeries carries the following 19 risks: 20 Number one, bleeding? 21 A. Yes. 22 Q. Infection? 23 A. Yes. 24 Q. Scarring? Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 6 of 35 PageID #: 624 Michael Noone, M.D. Golkow Technologies, Inc. Page 26 1 A. Yes. 2 Q. Inflammation? 3 A. Yes. 4 Q. Contraction of tissues? 5 A. Contraction of tissues for all those 6 procedures, I mean it depends how you define that, 7 but I'm aware of tissue changes that would be 8 called that. So, that is a yes. 9 Q. Organ and nerve damage? 10 A. Those are potential complications, yes. 11 Q. Pain? 12 A. Yes. 13 Q. Pain with intercourse? 14 A. Yes. 15 Q. Pelvic pain? 16 A. Yes. 17 Q. Subsequent urinary problems such as 18 retention, frequency, urgency? 19 A. Yes. 20 Q. Wound complications? 21 A. Yes. 22 Q. Neuromuscular problems such as myalgia 23 in the pelvic floor muscles? 24 A. Yes. Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 7 of 35 PageID #: 625 Michael Noone, M.D. Golkow Technologies, Inc. Page 27 1 Q. Recurrent urinary tract infections? 2 A. Yes. 3 Q. Have you always known since you started 4 performing these various procedures including the 5 TVT procedure with a midurethral sling that each of 6 those risks we just described could be mild? 7 A. Sure. 8 Q. That they could be moderate? 9 A. Right. 10 Q. That they could be severe? 11 A. Okay, yes. 12 Q. Have you always known that each of those 13 risks could be temporary or acute? 14 A. Right. 15 Q. Have you always known that those risks 16 that we have talked about could be more prolonged 17 or chronic in nature? 18 A. Right, yes. 19 Q. When you performed your TVT surgery on 20 Ms. Pocztowski, as we'll see that occurred in 21 May of 2004, did you know about each of the 22 potential risks that we mentioned -- 23 A. I believe so, yeah. 24 Q. -- just now? Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 8 of 35 PageID #: 626 Michael Noone, M.D. Golkow Technologies, Inc. Page 28 1 A. Yeah. 2 Q. And that included acute and potentially 3 chronic pelvic pain, right? 4 A. Right. 5 Q. Recurrent urinary tract infections? 6 A. I believe so. 7 MR. KEITH: Object to form. 8 BY MR. GOLDMAN: 9 Q. Did it include urge incontinence? 10 A. It did. 11 Q. Did it include recurrent stress 12 incontinence, in other words -- 13 A. Sure. 14 Q. -- that that condition might recur? 15 A. Recur. 16 Q. Did it include the knowledge back in 17 2004 that midurethral slings used in TVT procedures 18 had the risk of mesh erosion? 19 A. Yes. 20 Q. How did you learn, by the way, about the 21 potential risks associated with TVT surgeries 22 involving the midurethral sling? 23 A. Well, you have your training about 24 surgery that makes you aware of procedures you're Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 9 of 35 PageID #: 627 Michael Noone, M.D. Golkow Technologies, Inc. Page 31 1 Q. But you don't know if it was at the time 2 of the surgery, before the surgery or after the 3 surgery I assume? 4 MR. KEITH: Object as to form. 5 BY MR. GOLDMAN: 6 Q. Do you know one way or the other when 7 you read a document like this? 8 A. Base -- well, not specifically, no. Not 9 based on the limitations there, no. I would have 10 expected before that time. 11 Q. At some point before you -- 12 A. Placed it for -- 13 Q. -- placed it? 14 A. Yeah, I would expect so. 15 Q. Do you know -- let me ask you something 16 else, Doctor. When you -- withdrawn. 17 When you learn about risks associated 18 with procedures that you perform, do you only look 19 at a particular document or do you rely on your 20 entire wealth of knowledge about the risks? 21 A. You use more than one source for your 22 information. 23 Q. So, the sources that you told me before 24 were your training for surgery, right? Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 10 of 35 PageID #: 628 Michael Noone, M.D. Golkow Technologies, Inc. Page 32 1 A. Right. 2 Q. Your -- certain sling materials that you 3 had been exposed to before midurethral slings had 4 ever come to the market? 5 A. Right. 6 Q. Your management of patients who had 7 complications or even who had the midurethral sling 8 already implanted in them, right? 9 A. Right. 10 Q. Colleagues in discussions? 11 A. Right. 12 Q. Clinical experience, right? 13 A. Right. 14 Q. And, so, if a particular side effect or 15 complication is not listed in a particular 16 document, say, like an Instruction for Use, does 17 that mean that you're unaware of that particular 18 risk? 19 A. Well, not because it's absent from a 20 particular document. Perhaps you know it from 21 another source, of course. 22 Q. Now let's turn to Ms. Pocztowski. Do 23 you remember -- withdrawn. 24 In preparation for your deposition, Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 11 of 35 PageID #: 629 Michael Noone, M.D. Golkow Technologies, Inc. Page 38 1 stress urinary incontinence, sir, did you just rush 2 into recommending a surgical procedure for 3 Ms. Pocztowski? 4 A. No. 5 MR. KEITH: Object to form. 6 MR. GOLDMAN: What was wrong with the 7 question? 8 MR. KEITH: The "rush" part. 9 BY MR. GOLDMAN: 10 Q. Even though you were trained in various 11 surgeries to treat stress urinary incontinence, did 12 you recommend right at the outset to Ms. Pocztowski 13 that she have a surgical procedure? 14 A. I did not. 15 Q. What did you recommend? 16 A. We gave her a device that is called an 17 Introl bladder neck support prosthesis, which is 18 meant to help correct her incontinence. It's an 19 intravaginal pessary-type device. 20 Q. Did you feel at that time, in March of 21 1999, that that pessary device might help to 22 resolve her condition at least in the short term? 23 A. That's right. 24 Q. But did you also note that you think, Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 12 of 35 PageID #: 630 Michael Noone, M.D. Golkow Technologies, Inc. Page 39 1 quote, "for the long-term she would make an optimal 2 surgical candidate for complete correction"? Do 3 you see that? 4 A. Yeah, yes, I do. 5 Q. Why is it that you felt that ultimately 6 Ms. Pocztowski might require a surgical procedure 7 in order to address her stress urinary incontinence 8 and that she would be a good candidate for that? 9 A. I believe it related to the fact that 10 it's a challenge for a patient to want to use a 11 pessary or an intravaginal device as a long-term 12 means of managing the problem. 13 Q. As it turned out, it was something that 14 Ms. Pocztowski did not want to continue using, 15 right? 16 A. That's -- I believe that's correct, 17 yeah. 18 Q. Did you indicate in the last sentence of 19 that third paragraph, "Certainly we will optimize 20 non-surgical options in this patient," and then you 21 continue on, right? 22 A. Right. 23 Q. Has it always been your practice, sir, 24 to try to use the least invasive, most conservative Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 13 of 35 PageID #: 631 Michael Noone, M.D. Golkow Technologies, Inc. Page 40 1 approach to treat your patients' medical conditions 2 before exposing them to more pronounced risks of a 3 surgical procedure? 4 A. That's the typical practice. 5 Q. Is that what you did here with 6 Ms. Pocztowski? 7 A. It -- I did. 8 Q. Can you turn with me to page 143, 9 please. 10 Do you recognize this as a letter that 11 you wrote on March 18, 1999 to Dr. Lee again 12 updating him on your continued treatment of 13 Ms. Pocztowski for urinary incontinence? 14 A. Yes, that's what it is. 15 Q. Can you read what you wrote in the third 16 paragraph, sir. 17 A. Beginning "It did"? 18 Q. Yes. 19 A. "It did bring about a reduction in her 20 urinary incontinence but she still has some mild 21 occasional urge incontinence and stress 22 incontinence." 23 Q. So, did Ms. Pocztowski have urge 24 incontinence back in March of 1999 as well? Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 14 of 35 PageID #: 632 Michael Noone, M.D. Golkow Technologies, Inc. Page 41 1 A. Yes. 2 Q. Then you wrote, "At this time we will 3 remove her pessary as she did not" -- "as she does 4 not want to continue it for the time being." 5 A. Um-hmm. 6 Q. "Have her continue pelvic floor muscle 7 rehabilitation with Kegel contractions per our 8 protocol." 9 Right? 10 A. That's what I wrote, right, that's 11 there. 12 Q. So, did Ms. Pocztowski tell you that she 13 no longer wanted to use the bladder neck support 14 prosthesis that you had put in before? 15 A. That's right. 16 Q. And what are Kegel exercises, just 17 briefly? 18 A. Contraction of the pelvic floor muscle 19 that by simple description it's the bicycle seat 20 between your pubic bone and tailbone and across 21 your pelvic floor. Contraction exercises of that 22 muscle group can reduce stress as well as urge 23 incontinence. 24 Q. So, was your hope at this point that Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 15 of 35 PageID #: 633 Michael Noone, M.D. Golkow Technologies, Inc. Page 42 1 you've tried one conservative approach with the 2 pessary device and now you're going to try Kegel 3 exercises to see if that can help manage 4 Ms. Pocztowski's stress urinary incontinence? 5 A. Correct. 6 Q. Do you know from looking at the records, 7 Doctor, that the Kegel exercises did not do a good 8 enough job to manage this problem? 9 A. I believe that's what we documented, 10 yes. 11 MR. KEITH: Object to form. 12 BY MR. GOLDMAN: 13 Q. Did the Kegel exercises in your judgment 14 adequately address Ms. Pocztowski's stress urinary 15 incontinence? 16 A. They were not adequate. 17 Q. Can you turn now with me to page 20 of 18 Exhibit 4. 19 Are you with me there? 20 A. I am. 21 Q. Do you recognize this as a note in your 22 chart that you signed regarding a visit you had 23 with Ms. Pocztowski on May 4, 2004? 24 A. That's correct. Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 16 of 35 PageID #: 634 Michael Noone, M.D. Golkow Technologies, Inc. Page 51 1 would be the typical kind of discussion about the 2 limits. 3 Q. Did you, consistent with your practice, 4 likely tell Ms. Pocztowski that even though the 5 hope was for her TVT procedure to help resolve her 6 stress urinary incontinence, it might not 7 permanently cure it and it might return? 8 A. I would expect so, yeah. 9 Q. Did you inform Ms. Pocztowski that even 10 though she had symptoms of urge incontinence, that 11 she ought not expect the TVT procedure to resolve 12 it because that's not the purpose for which you 13 were performing it? 14 A. The sling is not expected to resolve 15 urge incontinence. 16 Q. Did you also then review a number of 17 potential risks associated with the various 18 procedures that you performed? 19 A. I did. 20 Q. Was one of the risks that you discussed 21 with Ms. Pocztowski the fact that she might need a 22 repeat surgery for prolapse? 23 A. I would have expected that be -- in 24 fact, that's exactly what we included. Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 17 of 35 PageID #: 635 Michael Noone, M.D. Golkow Technologies, Inc. Page 52 1 Q. Did you also include that you told 2 Ms. Pocztowski that she might need another surgery 3 for stress urinary incontinence if that occurred 4 again? 5 A. That's correct. 6 Q. Did you also describe the fact that 7 there were certain surgical morbidity and mortality 8 risks associated with the TVT surgery that you 9 performed? 10 A. That's right. 11 Q. What do you mean by that? 12 A. Well, specifically it's possible to have 13 a surgical death when you go to the OR, be it from 14 anesthesia complication or unforeseen adverse 15 event, but really it was a matter of saying surgery 16 carries risks, there are problems and pains and 17 discomforts that we perhaps cannot know until we do 18 it. 19 It's hard to list every single absolute 20 event that may happen. So, we talked in those 21 terms. And that's what that surgical morbidity and 22 mortality references. 23 Q. Was it consistent with your practice 24 also, Dr. Noone, that you wouldn't identify every Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 18 of 35 PageID #: 636 Michael Noone, M.D. Golkow Technologies, Inc. Page 53 1 single risk that you discuss with a patient 2 regarding a surgery like TVT in your medical chart? 3 A. Well, right, you cannot include every 4 single absolute possibility as much as you 5 certainly advise them of the relevant ones. 6 Q. And we'll look at some references later 7 such as the potential risk of mesh erosion is 8 something you don't mention here, but is that 9 something that you typically would have discussed 10 with a patient like Ms. Pocztowski before your TVT 11 procedure in May of 2004? 12 A. I would have expected so, sure. 13 Q. And would you likely have expected to 14 tell Ms. Pocztowski about the potential risk of 15 pelvic pain from a TVT surgery? 16 A. It would have been something I would 17 expect to discuss. 18 Q. And all the other risks that we 19 discussed before that you were aware of? 20 A. Agreed. 21 Q. Can you turn with me to page 59, please, 22 in Exhibit 4. 23 Is this a note that you dictated on 24 May 7, 2004 as part of the "History and Physical" Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 19 of 35 PageID #: 637 Michael Noone, M.D. Golkow Technologies, Inc. Page 55 1 prolapse were carefully reviewed. Patient has 2 elected vaginal hysterectomy with bilateral 3 salpingo-oophorectomy as part of this repair per 4 the indications outlined with Dr. Dolling." 5 A. Right. 6 Q. "The surgical limitations of treatment 7 of prolapse and incontinence were carefully 8 reviewed. Patient understands the risks and 9 desires to proceed." 10 Do you see that? 11 A. Yes. 12 Q. Was it your understanding that 13 Ms. Pocztowski understood the potential risks of 14 TVT surgery such as those you described before, 15 pelvic pain, the need for repeat surgeries, the 16 potential for recurrent urinary tract infections, 17 and decided to proceed with the procedure 18 nonetheless? 19 A. That's correct. 20 Q. "Particularly" -- you wrote, 21 "Particularly with the evidence of subjective urge 22 incontinence and low pressure urethra, the goals 23 and the limits were clearly reviewed." 24 Is that similar to what you told us Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 20 of 35 PageID #: 638 Michael Noone, M.D. Golkow Technologies, Inc. Page 56 1 before that you didn't want Ms. Pocztowski's 2 expectations to be unreasonable to think that her 3 urge incontinence would resolve by virtue of the 4 TVT surgery? 5 MR. KEITH: Object to form. 6 BY MR. GOLDMAN: 7 Q. When you talk about the goals and limits 8 here, what were you referring to? 9 A. The urge incontinence is something that 10 she had been experiencing, at least as relates to a 11 sling procedure for treating stress incontinence. 12 The low-pressure urethra is a more 13 severe type of stress incontinence, which in fact 14 is treated well with the sling, but is thought to 15 be more difficult to treat surgically than a less 16 severe form of stress incontinence. 17 Q. So, did Ms. Pocztowski have a more 18 severe form of stress incontinence because of this 19 low-pressure urethra? 20 A. That was -- that's correct. 21 Q. Did you also write, "Postoperative 22 dysfunctional voiding, sling erosion, damage to the 23 bowel and bladder, surgical complications requiring 24 transfusions or delayed or immediate infections, Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 21 of 35 PageID #: 639 Michael Noone, M.D. Golkow Technologies, Inc. Page 57 1 and issues of surgical morbidity and mortality were 2 carefully reviewed." 3 Do you see that? 4 A. Yes. 5 Q. After describing those and other risks, 6 did Ms. Pocztowski decide to proceed with the 7 surgeries? 8 A. That's right. 9 Q. If you turn to the next page, do you 10 have a section there called "Smoking History"? 11 A. Correct. 12 Q. Did you indicate whether Ms. Pocztowski 13 had a history of smoking? 14 A. I did. 15 Q. What did you write? 16 A. "Smoking one pack of cigarettes a day." 17 Q. Why was that significant to include in 18 this medical record? 19 A. Well, in any medical record, tobacco 20 history is considered relevant; and it affects 21 anesthesia risk and even surgical -- of healing and 22 infection. 23 (Clarification requested by the 24 reporter.) Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 22 of 35 PageID #: 640 Michael Noone, M.D. Golkow Technologies, Inc. Page 59 1 finding diagnostically. 2 Q. Then you reference "Urge incontinence," 3 and then 3 and 4 say "Cystocele involvement" and 4 "Rectocele involvement," right? 5 A. That's what it says. 6 Q. What did you mean by that? 7 A. I have a feeling I said something 8 different than involvement, but I referenced it as 9 with the vaginal support she had some degree of 10 cystocele and rectocele. 11 Q. By the way, did you ever use a Prolift 12 product for Ms. Pocztowski? 13 A. No. 14 Q. You never used anything that was made by 15 Ethicon called Prolift to address any prolapse that 16 she had, right? 17 A. That's correct. Did not. 18 Q. Okay. Can you now turn with me, please, 19 to page 49. 20 Do you recognize this as the operative 21 report that you dictated after you performed your 22 surgeries on Ms. Pocztowski on May 4, 2000 -- 23 withdrawn. 24 Is this your operative report reflecting Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 23 of 35 PageID #: 641 Michael Noone, M.D. Golkow Technologies, Inc. Page 60 1 the surgery you performed on Ms. Pocztowski on 2 May 12, 2004? 3 A. Yes, that is. 4 Q. Do you list the procedures that you 5 performed in the middle of the page? 6 A. Yes. 7 Q. Is the first procedure a total vaginal 8 hysterectomy and the second bilateral 9 salpingo-oophorectomy with modified McCall's 10 uterosacral ligament suspension of the vaginal 11 wall? 12 A. That's essentially it, yes. 13 Q. And the hysterectomy and the 14 salpingo-oophorectomy was performed by Dr. Dolling? 15 A. I believe so, yes. 16 Q. You performed the uterosacral ligament 17 suspension with that Gore-Tex suture, right? 18 A. Right. Gore-Tex. 19 Q. And you also did the TVT surgery, 20 correct? 21 A. That's right. 22 Q. Did you identify any complications at 23 all that you had in performing these surgeries on 24 Ms. Pocztowski? Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 24 of 35 PageID #: 642 Michael Noone, M.D. Golkow Technologies, Inc. Page 73 1 Q. As it says under -- 2 A. That's what we documented. 3 Q. Okay. Then under "Physical Exam" you 4 looked at Ms. Pocztowski's pelvic area, right? 5 A. Correct. 6 Q. And did you find any areas of concern to 7 you? 8 A. I did. 9 Q. And what was the area of concern? 10 A. There was a -- at the apex of the vagina 11 you could feel a suture knot. 12 Q. Was the suture knot that you felt the 13 knot that we described earlier having to do with 14 the Gore-Tex suture? 15 A. That's exactly what it was attributed 16 to. 17 Q. The Gore-Tex suture was what you used to 18 perform Ms. Pocztowski's uterosacral suspension, 19 not the TVT procedure, right? 20 A. Correct. 21 Q. So, you identify this issue with the 22 Gore-Tex suture. Was there any associated 23 granulation tissue observed? 24 A. There was none. Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 25 of 35 PageID #: 643 Michael Noone, M.D. Golkow Technologies, Inc. Page 76 1 tenderness but was seen at the last office visit," 2 and I'm not seeing a reference to dyspareunia just 3 as I quickly scan through this. 4 Q. I can represent to you it isn't in 5 there. 6 A. Okay. Thank you. 7 Q. If you turn with me now to page 57. Do 8 you see that this is an operative report dated 9 January 31, 2007? 10 A. That's right. 11 Q. Is this the operative report reflecting 12 your removal of that Gore-Tex suture that had been 13 used in the uterosacral suspension procedure? 14 A. That's right. 15 Q. Under "Preoperative Diagnosis" you 16 identify this "Vaginal suture granuloma/foreign 17 body from previous uterosacral suspension Gore-Tex 18 suture." 19 Do you see that? 20 A. That's right. 21 Q. Did you identify any foreign body or 22 foreign body reaction relating at all to the TVT 23 procedure? 24 A. No. Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 26 of 35 PageID #: 644 Michael Noone, M.D. Golkow Technologies, Inc. Page 77 1 Q. You then indicate the procedure is to 2 remove that vaginal apex suture and cystoscopy. 3 You did that, right? 4 A. I did. 5 Q. Then -- was that procedure a success? 6 A. It -- well, yes. 7 Q. When you performed the vaginal suture 8 removal from Ms. Pocztowski in January of 2007, did 9 you identify any areas of mesh erosion or mesh 10 exposure related to the TVT surgery? 11 A. I did not. 12 Q. What did the cystoscopy show? 13 A. I'll quote from the record there. 14 The cystoscopy showed that urine flow 15 was coming from each ureter and there were two 16 normal ureters. There's one on each side. There 17 is a finding of the trigone called squamous 18 metaplasia, which is, in simple terms, a normal 19 finding that you will see commonly of the trigone. 20 Diffuse inflammation that we had seen in 21 her previous office cystoscopy had improved, and we 22 made reference to her other workup for the CT scan. 23 Q. Okay. 24 A. Essentially a normal cystoscope. Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 27 of 35 PageID #: 645 Michael Noone, M.D. Golkow Technologies, Inc. Page 84 1 Q. In April of 2012 Ms. Pocztowski alleges 2 that as a result of having the Ethicon Gynecare TVT 3 device implanted in her, "Plaintiff has experienced 4 significant mental and physical pain, disability, 5 suffering, has sustained permanent injury and 6 permanent and substantial physical deformity, has 7 suffered financial or economic loss, including but 8 not limited to obligations for medical services and 9 expenses and other damages." 10 Do you see that? 11 A. I see it. 12 Q. Based on your observations and treatment 13 of Ms. Pocztowski, did you ever note any 14 significant mental or physical pain she was 15 experiencing following your implant of the TVT 16 device? 17 MR. KEITH: Object as to form. 18 BY THE WITNESS: 19 A. You know, I -- we -- whatever is in the 20 record is in the record. But she was -- I guess 21 you might say that the bladder infections were part 22 of things that were affecting her. But to note 23 that in my record as a result of the TVT that that 24 was attributed there, no, I did not. Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 28 of 35 PageID #: 646 Michael Noone, M.D. Golkow Technologies, Inc. Page 85 1 BY MR. GOLDMAN: 2 Q. Did you note any kind of disability or 3 permanent injury in your treatment of 4 Ms. Pocztowski after your surgery in May of 2004? 5 MR. KEITH: Object as to form. 6 BY THE WITNESS: 7 A. I don't believe I documented that at 8 all. 9 BY MR. GOLDMAN: 10 Q. If you go with me now to page 164 of 11 Exhibit 4, sir, of your chart. 12 A. Yes. 13 Q. This I believe is the last time that 14 Ms. Pocztowski visits with you. It's April of 15 2013. Just tell me when you're there, please. 16 A. Yes. 17 Q. Is the date of this visit April 5, 2013? 18 A. That's right. 19 Q. Is that just about seven years or so 20 since your last visit with Ms. Pocztowski -- 21 withdrawn. 22 A. About six years. 23 Q. Was it -- withdrawn. 24 Is this visit from April 5, 2013 about Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 29 of 35 PageID #: 647 Michael Noone, M.D. Golkow Technologies, Inc. Page 91 1 Q. Did you indicate that the TVT slings 2 caused her urinary tract infections? 3 A. I did not indicate that to her. 4 Q. Did you indicate to her that any 5 problems that she was experiencing were due to the 6 TVT mesh? 7 A. I did not conclude that at the time, no. 8 Q. I'm just going to wrap up with a few 9 questions. 10 Do you see any reason why -- withdrawn. 11 Did you impose any clinical limitations 12 on Ms. Pocztowski based on your surgery from 13 May 2004? 14 A. I don't believe so, no. 15 Q. As of April 2013 did you see any reason 16 why she couldn't go fishing if she wanted to? 17 MR. KEITH: Object to form. 18 BY THE WITNESS: 19 A. I don't see any objection to that or any 20 problem with fishing. 21 BY MR. GOLDMAN: 22 Q. Did you treat Ms. Pocztowski from 1999 23 to 2013? 24 A. I did not. Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 30 of 35 PageID #: 648 Michael Noone, M.D. Golkow Technologies, Inc. Page 93 1 A. Yes. 2 Q. Did she have any complications during 3 your surgery? 4 A. No. 5 Q. Have you noted any complications 6 whatsoever that Ms. Pocztowski experienced as a 7 result of your TVT surgery? 8 A. I did not. 9 Q. Did your second surgery include a 10 uterosacral suspension with Gore-Tex suture? 11 A. At the time of the sling, yes. 12 Q. The Gore-Tex suture was something you 13 removed and had nothing to do with mesh, right? 14 A. That's right. 15 Q. You were aware in May of 2004 of the 16 following risks with any SUI surgery including TVT: 17 Acute and chronic pelvic pain, right? 18 A. Right. 19 Q. Urinary tract infection, right? 20 A. Right. 21 Q. Mesh erosion? 22 A. Right. 23 Q. Dyspareunia? 24 A. Correct. Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 31 of 35 PageID #: 649 Michael Noone, M.D. Golkow Technologies, Inc. Page 94 1 Q. Recurrent stress urinary incontinence? 2 A. Yes. 3 Q. You concluded that the benefits of TVT 4 surgery with mesh outweighed the risks for 5 Ms. Pocztowski, correct? 6 A. That's right. 7 MR. KEITH: Andy, your time -- 8 BY MR. GOLDMAN: 9 Q. Do you stand by that decision today? 10 MR. KEITH: Your time has expired. 11 BY THE WITNESS: 12 A. Right. 13 BY MR. GOLDMAN: 14 Q. Did you get my last question? 15 Do you stand by that decision today? 16 A. I stand by that decision today. 17 Q. Let me make sure it came out because we 18 were talking over each other. 19 Do you stand by your decision to perform 20 a TVT surgery with mesh for Ms. Pocztowski today? 21 A. Yes. 22 MR. GOLDMAN: Thank you. Those are all the 23 questions I have. Thank you very much. 24 THE VIDEOGRAPHER: Going off the record at Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 32 of 35 PageID #: 650 Michael Noone, M.D. Golkow Technologies, Inc. Page 144 1 BY THE WITNESS: 2 A. We did not know the long-term at that 3 time, so I did not have an absolute on that. 4 BY MR. KEITH: 5 Q. Okay. Lifelong risk of exposure? 6 MR. GOLDMAN: Object to the form. 7 BY THE WITNESS: 8 A. Similar limitation of reading into the 9 future. 10 BY MR. KEITH: 11 Q. Prior to implanting this in Deb, were 12 you aware of a chronic foreign body reaction 13 associated with a TVT? 14 MR. GOLDMAN: Object to the form. 15 BY THE WITNESS: 16 A. I was not aware of a specific issue 17 there. 18 BY MR. KEITH: 19 Q. Mesh degradation? 20 MR. GOLDMAN: Object to the form. 21 BY THE WITNESS: 22 A. Not specifically aware of that. 23 BY MR. KEITH: 24 Q. Mesh shrinkage? Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 33 of 35 PageID #: 651 Michael Noone, M.D. Golkow Technologies, Inc. Page 145 1 MR. GOLDMAN: Same objection. 2 BY THE WITNESS: 3 A. I was aware of some concern there. 4 BY MR. KEITH: 5 Q. Mesh deformation? 6 A. I was aware of that. 7 Q. Where were you aware of that from, just 8 out of curiosity? 9 A. From -- 10 MR. GOLDMAN: Object to the form. 11 BY THE WITNESS: 12 A. Surgical judgment. You sort of place 13 it. If it's under too much tension or if it's 14 rolled, you have to place it correctly, which is 15 actually the theme of the article you referenced. 16 It's like you got to do it correctly. 17 BY MR. KEITH: 18 Q. It is. 19 A. So... 20 Q. Mesh roping? 21 MR. GOLDMAN: Object to form. 22 BY THE WITNESS: 23 A. Roping is a term that relates to that 24 deformation. So, roping as a term, no, I was not Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 34 of 35 PageID #: 652 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 Michael Noone, M.D. I, CORINNE T. MARUT, C.S.R. No. 84-1968, Registered Professional Reporter and Certified Shorthand Reporter, do hereby certify: That previous to the commencement of the examination of the witness, the witness was duly sworn to testify the whole truth concerning the matters herein; That the foregoing deposition transcript was reported stenographically by me, was thereafter reduced to typewriting under my personal direction and constitutes a true record of the testimony given and the proceedings had; That the said deposition was taken before me at the time and place specified; That the reading and signing by the witness of the deposition transcript was agreed upon as stated herein; That I am not a relative or employee or attorney or counsel, nor a relative or employee of such attorney or counsel for any of the parties hereto, nor interested directly or indirectly in the outcome of this action. It was requested before completion of the deposition that the witness, MICHAEL NOONE, M.D., have the opportunity to read and sign the deposition transcript . ~~~1~ CORINNE T. MARUT, Certified Reporter (The foregoing certification of this 18 transcript does not apply to any reproduction of the same by any means, unless under 19 the direct control and/or supervision of the certifying reporter.) 20 21 22 23 24 Golkow Technologies, Inc. Page 194 Case 2:12-cv-01470 Document 62-2 Filed 07/08/16 Page 35 of 35 PageID #: 653 EXHIBIT C Redacted pursuant to Fed. R. Civ. P. 5.2 and PTO 11 Case 2:12-cv-01470 Document 62-3 Filed 07/08/16 Page 1 of 5 PageID #: 654 PRIVILEGED AND HIGHLY CONFIDENTIAL INFORMATION Patient: Debra Pocztowski Records Provider: Advocate Lutheran General Hospital (Medical Records Department) 1775 Dempster Street Medical Records, 3rd Floor South Park Ridge, IL 60068 847 -723-8265 Records Obtained: 03/3012013 231962.008.0089 - 231962.008.0838 POCZTOWSKID ALGH MDR00089 - POCZTOWSKID ALGH MDR01568 - - - - Records provided by: The Marker Group 13105 Northwest Fwy Houston, TX 77040 713-460-9070 PDF version generated on 03/31120 13 (NWFOO 10) 750 pages plus cover sheet PRIVILEGED AND HIGHLY CONFIDENTIAL INFORMATION Case 2:12-cv-01470 Document 62-3 Filed 07/08/16 Page 2 of 5 PageID #: 655 L Advocate Lutheran General Hospital cc: Kristin Dolling, M.D. Michael Noone, M.D. REASON FOR ADMISSION: Surgical treatment of genuine stress incontinence and urethral hypermobility with a concomitant uterovaginal prolapse repair for the problem of stress incontinence and menorrhagia with a planned procedure of a TVT pubovaginal sling modified McCall enterocele repair, anteroposterior repair with vaginal hysterectomy, bilateral salpingo-oophorectomies with Dr. Kristin Dolling. HISTORY OF PRESENT ILLNESS: The patient is a 47-year-old gravida 4, para 3-0-1-3 female referred by Dr. Kristin Dolling with the problem of urinary leakage manifesting in stress and urge incontinence for greater than 2 years' duration. Any amount of exercise results in urinary leakage for this patient, who wears 3 heavy pads a day as routine. There is 2 per night nocturia, and she denies urinary frequency, but even a slight sound or evidence of running water forces her to rush to the bathroom. Her official first visit on May 4, 2004, showed grade 2 uterine descent, a grade 1 to 2 cystocele, grade 0 to 1 rectocele. She is planning a vaginal hysterectomy and bilateral salpingo-oophorectomies for persistent abnormal uterine bleeding. Manifest diagnosis is menorrhagia. Our examination showed the above-stated pelvic support defects. Comprehensive urodynamic testing revealed a bladder capacity of 371, analysis with a stable detrusor 8 point pressures, as well as 58 cm of water with prolapse reduction, and maximally the closing pressure were well in excess of 27 cm of water, recorded as 58 and 54 on two separate profiles. The voiding studies showed mildly elevated voiding pressures of 37 cm of water at peak flow, but the patient had effective voiding with good peak flow rate, and normal uroflowmetry, with the exception of somewhat slow-average flow rate. The nature of surgical treatment of surgical treatment of incontinence and prolapse was carefully reviewed. Patient has elected vaginal hysterectomy with bilateral salpingo-oophorectomy as part of this repair per the indications outlined with Dr. Dolling. The surgical limitations of treatment of prolapse and incontinence were carefully reviewed. Patient understands the risks and desires to proceed. Particularly with the evidence of subjective urge incontinence and low-pressure urethra, the goals and limits were clearly reviewed. Postoperative dysfunctional voiding, sling erosion, damage to bowel an bla9der, surgical complications requiring transfusion or delayed or immediate infections, and issues of surgical morbidity and mortality were carefully reviewed. The patient desires to proceed. POCZTOWSKI, DEBRA MRN#: ACCT#: ADMIT: 05/12/2004 ROOM: Michael Noone, M.D. SVC: SGP DICTATED BY: Michael Noone, M.D. DD: 05/07/2004 DT: 05/07/2004TD: 08:37 TT: 11:09 K#: PREOPERATIVE HISTORY & PHYSICAL 5/13 POCZTOWSKID _ ALGH _ MDR00288 REDACTED REDACTED REDACTED Case 2:12-cv-01470 Document 62-3 Filed 07/08/16 Page 3 of 5 PageID #: 656 Advocate Lutheran General Hospital PAGE 2 PAST OBSTETRICAL/GYNECOLOGICAL HISTORY: Gravida 4, para 3-0-1-3 with largest baby 7 pounds 2 ounces. Menarche age 10. History of tubal ligation for birth control. Pap and mammogram were up-to-date as of August 2003. She is sexually active. PAST MEDICAL HISTORY: Ulcer disease, irritable bowel syndrome, possible idiopathic leg edema. PAST SURGICAL HISTORY: Ovarian cystectomy August of 2002, gallbladder removal October of 2000, tubal ligation July of 1986. ALLERGIES: None. MEDICATIONS: Lasix 40 mg a day, potassium supplement 10 mEq once a day, Low-Ogestrel oral contraceptive pills to help menorrhagia 2 per day for the last 7 days, then once a day ending mid-April, Zofran 4 mg 1 to 2 per day. SOCIAL HISTORY: Smoking 1 pack of cigarettes a day. No excessive alcohol or illicit drug use. FAMILY HISTORY: Heart disease, diabetes, and breast cancer. No gynecologic/pelvic cancer. No stroke. REVIEW OF SYSTEMS: No fevers, chills, sweats, or headaches. Eyes: No blurred vision, double vision, or pain. Allergy/dermatologic: No hay fever. No drug allergies. Endocrine: No excessive thirst, not too hot or cold, not tired or sluggish. Symptoms of hot flashes and perimenopausal changes, irregular menses. Neurological: No tremors, no dizzy spells, numbness, or tingling. Gastrointestinal: No nausea, vomiting, diarrhea, no constipation, no reflux symptoms or heartburn. Cardiovascular: No chest pain, no varicose veins, no hypertension, no palpitations. Integument: No skin rash, no bullae, no persistent itch. Respiratory: No wheezing, no frequent cough, no shortness of breath. Hematologic/lymphatics: No swollen glands, no blood clotting problems. Genitourinary: See HPI. Ears, nose, and throat: There are no infections, sore throat, no sinus problems. The patient has occasional problems with nausea and indigestion and heartburn now actively controlled. POCZTOWSKI, DEBRA MR.N# : ACCT#: ADMIT: 05/12/2004 ROOM: Michael Noone, M.D. SVC: SGP DICTATED BY: Michael Noone, M.D. DD: 05/07/2004 DT: 05/07/2004TD: 08:37 TT: 11:09 K#: PREOPERATIVE HISTORY & PHYSICAL POCZTOWSKID _ ALGH _ MDR00289 REDACTED REDACTED REDACTED Case 2:12-cv-01470 Document 62-3 Filed 07/08/16 Page 4 of 5 PageID #: 657 Advocate Lutheran General Hospital PAGE 3 PHYSICAL EXAMINATION: GENERAL: Well-developed, well-nourished female, in no acute distress. HEENT: Unremarkable. NECK: Without thyromegaly. ABDOMEN: Soft, nontender, no hepatosplenomegaly. No hernia. PELVIC: Normal external genitalia. Grade 2 uterine descent with a grade 2 enterocele/apex descent. Grade 1 to 2 cystocele; 0 to 1 rectocele greater than 30 degrees. At the urethrovesical junction, hypermobility; pelvic floor strength is 2 out of 5 with normal anocutaneous bulbocavernosus reflex with a positive cough stress test seen with 30 mL of bladder volume in the standing position. Bimanual exam shows a mobile uterus, no adnexal masses. Rectovaginal exam is negative. IMPRESSION: 1. Genuine stress incontinence, low-pressure urethra by leak point pressure assessment, but not by maximum urethral closure pressure assessment on sitting fully at rest profile. 2. Urge incontinence, stable detrusor, mildly decreased maximum cystometric capacity. 3. Cystocele involvement. 4. Rectocele involvement. 5. Uterine descent. 6. Menorrhagia, perimenopausal changes. RECOMMENDATIONS: Patient is having total vaginal hysterectomy with bilateral salpingo-oophorectomy with a planned vaginal apex suspension with a modified McCall enterocele suspension, anterior and posterior repairs and TVT pubovaginal sling. The nature and limits of the treatment of surgical treatment of incontinenJ were carefully reviewed. The patient desires to proceed. 1M Michael Noone, M.D. DICTATED BY: Michael Noone, M.D. DD: 05/07/2004 DT: 05/07/2004TD: 08:37 POCZTOWSKI, DEBRA MRN# : ACCT#: ADMIT: 05/12/2004 ROOM: SVC: SGP TT: 11: 09 K#: PREOPERATIVE HISTORY & PHYSICAL POCZTOWSKID _ ALGH _ MDR00290 REDACTED REDACTED REDACTED Case 2:12-cv-01470 Document 62-3 Filed 07/08/16 Page 5 of 5 PageID #: 658 EXHIBIT D Redacted pursuant to Fed. R. Civ. P. 5.2 and PTO 11 Case 2:12-cv-01470 Document 62-4 Filed 07/08/16 Page 1 of 4 PageID #: 659 PRIVILEGED AND HIGHLY CONFIDENTIAL INFORMATION Patient: Debra Pocztowski Records Provider: Doctors of the North Shore 6131 West Dempster Street Morton Grove, IL 60053 847 -967-5010 Records Obtained: 0311412013 231962.020.0017 - 231962.020.0289 POCZTOWSKID DOCNS MDR00017 - POCZTOWSKID DOCNS MDR00289 - - - - Records provided by: The Marker Group 13105 Northwest Fwy Houston, TX 77040 713-460-9070 PDF version generated on 03/15/20 13 (NWFOO 10) 273 pages plus cover sheet PRIVILEGED AND HIGHLY CONFIDENTIAL INFORMATION Case 2:12-cv-01470 Document 62-4 Filed 07/08/16 Page 2 of 4 PageID #: 660 ' No~t Suburban Uroloplats. Ltd. : fl2/20/2013 03: 18 pm Brua: BeII~:Dl 1775B.a.rcl Pm;Ridp.JL U: Deborab Nc2:to1niki Dclr9ru= DoaJ.lJl. N.na. 1IlD. FAa ItItwM D. r-. ItI.J).. F,fa ¥9' ...... M.D. lllW Debcnh the ofIloetocky. Tbia is a SO-yw--okl woman wbo WII m:arIIy tJul4lO baw III Eo coli' tract infIc:doA. Shebu axopIaillts of occaioul dyui.a. ~ aod risbt fJaDk cW'lfCICIIII~ Sbe lwd ....... m 104"F teclIIIDtly ID4 WU Ileal in 1he etLliCi:JUIo!I) mom. At t:Mt time. she CIlPIIiaclDa ~ tigbHidcd 'flak dillOOlDfbrt. She WI8 trc:eIed witIl II2tiModcI aDd .~ ..... 6. ~mom.. 8bt: is DOt lIMICot.lDY imaatDa .... tbIt... .. that time. She doc:a t:oml.ofcblmllc 1Mipc. ~~IftA,TJON: She ia 1IIDdcrJIeIy ~ ~ ere DO palpable &at or lbnfl DO CVA 1mda: .... Tbc lWoD.wDiI .............. The pfdprably Ililk!aded. no pelvic CXIID IhMn no mdalcc for VIIiDaI or urednl is DO ~ tendemc:u OIl pelvic aarniNc;IQa IIId thoro is Do c:vicIeace fbr DEBRA A. POCZTOWSKl DOB /1956 294/300 POCZTOWSKID DOCNS MDR002 REDACTED Case 2:12-cv-01470 Document 62-4 Filed 07/08/16 Page 3 of 4 PageID #: 661 PATIENT: DcbcIbm Poc:2toMki PAGE: 2 her c:mpidaI1ly on K.ctJ1Ilt IocIay based an the urine cultwc rcsaltll from list to tho fiK¢ IbIt her urinalysis today doe. iDdiClte alitelibood ofpcnisteut infecticm. I will Ye her reIln to the office for a t'CD8l1lltruauDd. bllddcr sea. and C)'IIOecopy. wDl allow l\'8hsattoa oftbe rlJbt-sided flank pain IOd allow us to UIICD far incomplete GIIptyiaa ad foni.p bodi. within the bladder. I will be S1R to update)GO OD the fiDdinp. n.ak. you for ~111 to _ .. m CIOGIUltadan today. s~ J.mi.~MJ). cc.. MicbIcI. ~ N.D .. 1875 DempIIa StrIIet. SuIte." PIrk IJdp.1J1imU 60068 SA.07.05ID!nVI2...j 02/20/2013 03:18 pm I J I I I I I i !. I I , I I i i I I [ ! DEBRA A. POCZTOWSKI DOB /1956 295{300 POCZTOWSKID_DOCNS MDR00285 REDACTED Case 2:12-cv-01470 Document 62-4 Filed 07/08/16 Page 4 of 4 PageID #: 662 EXHIBIT E Redacted pursuant to Fed. R. Civ. P. 5.2 and PTO 11 Case 2:12-cv-01470 Document 62-5 Filed 07/08/16 Page 1 of 8 PageID #: 663 PRIVILEGED AND HIGHLY CONFIDENTIAL INFORMATION Patient: Debra Pocztowski Records Provider: Plaintiff Profile Form ' 39192 Records Obtained: 01/31/2013 231962.001.0001 - 231962.001.0006 POCZTOWSKID PPF 00001 - POCZTOWSKID PPF 00006 - - - - Records provided by: The Marker Group 13105 Northwest Fwy Houston, TX 77040 713-460-9070 PDF version generated on 01/31/2013(NWFOO 10) 6 pages plus cover sheet PRIVILEGED AND HIGHLY CONFIDENTIAL INFORMATION Case 2:12-cv-01470 Document 62-5 Filed 07/08/16 Page 2 of 8 PageID #: 664 IN THE UNITED STATES DISTRICT COURT SOUTHERN DISTRICT WEST VIRGINIA CHARLESTON DIVISION IN RE: ETHICON, INC., PELVIC REPAIR ) SYSTEM PRODUCTS LIABILITY LITIGATION ) I Plaintiff: ) ) ) ) ) ) ) ) ) ) MDL No.: 2327 No. 2:12-cv-01470 Debra Pocztowski Na.me of Plaintiff CERTIFICATE OF SERVICE I hereby certify that on December 8, 2012. I have served the foregoing Plaintiff Profile Form upon the following: Butler, Snow, 0 1Mara, Stevens & Cannada, PLLC 1020 Highland Colony Parkway Suite 1400 Ridgeland, MS 39157; and Thomas,Combs & Spann PLLC 300 Summers Street, Suite 1380 Charleston, WV 25301 by sending a copy of the same via email to PPF@tcspllc.com and ppf@butlersnow.com before 5:00 p.m. on this 8th day of December, 2012. By: ls/Elise A. Waisbren Attorney for Plaintiff Stephen D. Phillips (ARDC # .6189372) Elise A. Waisbren (ARDC # 6307256) TeiTence M. Quhm (ARDC # 6275734) PHILLIPS LAW OFFICES 161 N. Clark Street, Suite 4925 Chicago, IL 60601 (312) 346-4262 POCZTOWSKID PPF 00001 - - Case 2:12-cv-01470 Document 62-5 Filed 07/08/16 Page 3 of 8 PageID #: 665 REDACTED Case 2:12-cv-01470 Document 62-5 Filed 07/08/16 Page 4 of 8 PageID #: 666 Lot Number: 1145731 __..;.;-~~---~---~~---------~~ Implanting Sur-geon: Michael Noone, M.D., Kristin.Dolling, M.D .• KeJlt§iudzinski, Medical Facility: Lutheran General Hospital in Pa.rk Ridgo, Illinois Date of impJant: ______ _ _ _ ____ _____ ~~---- R.eas<>n for lmplantatwn: ______ _ ___ _ ______ _ _ _ _ Brand Name: ---~-~---~- _____ Mfg. ______ _ lm p 1 an tiog Su.rgeon: --- ------ - ------------ Medical F1:1cility: - - - ----------· ·.Attach medical evidence nf product identljlcatum. Date of surgery(s): Approx. January 2007. Type of surgery(s): Revision. ExpJa.ntiog slt.-geon: Michael Noone, M.D. Medical Facllity: LuthO'Ian General Hospital in Park Ridge, n, Reason for E:xpJant: issues related to pelvic region; Fistula; :revision Date of surgery(s): _A-=-p-=-p_xo~x_. S_e_.c.p_t._2_0_0_9 ___________ ~---- Type of surgery(s): Bo~~!_!tesection Explanting surgeon: Robert Sulkowski, M.D. Medical Facility: Lutheran General Hospital --- -·- ····-------·-· - Reason for E:s:plant: _____ _..__ ___________ ___ _ 0 Pain 0 Fistulae - 0 Erosion ~ Recurrence 0 Extrusion 0 Bleedin2 l?J Infection 0 Dyspareunia 0 Urina.-y :Problems 0 Neuromuscular problems l!J Bowel Problems 0 Vaeinal Scarrln~ 2 Pleas~ Initial Qt_ POCZTOWSKID _PPF 00003 Case 2:12-cv-01470 Document 62-5 Filed 07/08/16 Page 5 of 8 PageID #: 667 ( D Organ l>erl'oratiou I 0 Other Nnm ber of Pregnancies: _5 __ Number of Live Births: 3 - -- Date ofHysterectomy(ies) and Name of Hospital Where Performed: App)(. 5/2004 Prior to the First Implant, Have Yo11 Ever Had: Lupus Diabetes Auto brnnune Disorder Endornetriosis Pelvic Paro Syndrome or Disorder Fibroids Adhesive Disease .Arc you claiming damages for lost wages: {..1 Yes If so, for what time period: Ap~. 2004- Pres Have you ever filed for bao.kroptcy: [.<'] Yes ( ] No · lfsot when? _A .... P .... P_x._2_0_1_0 _ _____ _ Do you ha~e a computer: [ ] Yes VJ No [ ) No If so, are you a member of Facebook, Linkedln or other social media website$: [./] Ye.s [ ) No · Which ones: Facebook and LinkedIN Primary Ca.re Physicians: Name: Daniel Lazar, M.D. Addre,,tJ; 6131 Dempster St, Morton Grove, IL 60053 · Appro:d1.J1ate Period oCfreatment; _ A....,p_..P_x_. 1_9_9-'$_-_P_r_es_·e_n_t - -·---------- 3 POCZTOWSKID _PPF _ 00004 Case 2:12-cv-01470 Document 62-5 Filed 07/08/16 Page 6 of 8 PageID #: 668 Name: Jane Bang, M.D. Address: 7900 N Milwaukee Ave Ste 233. Niles, JL 60714 Approximate Period of Tfeatment: Appx. Jan. 2007 - Aug. 2007 Name; Kristin Dolling, M.D. ,Address: 1875 Dempster Street Park Ridge, IL 60068 App~omnat~ Period of Treatment: _A-=p=p_x_. 2_00_ 2_-_2_0_0_4 _ ______ _ ·- - - Adda'ess: Approximate Period of Treatment: -------~------------ u.-ologists: Name: Michael Noone, M.D. Address: 1875 Dempster Street Pro:k Ridge, IL 60068 .Approximate Period o{Treatment: _A....c;p:..:P_X_-_20_0_4_-_2_0_0_·7 _ ___________ _ Name: Investigation Continu.es Appro:idro.nte Period of Treabnent: - - --- - - --- - - ------ - - fsychiatrists/Psychologists (Answer only if making a claim for emotionalfosychological fujury beyond nsual paio and sufferiag): Name; Objection. Information requested is privileged. Approximate .Period of Treatment:- ------------------ 4 Please Initial~ POCZTOWSKID _PPF _ 00005 Case 2:12-cv-01470 Document 62-5 Filed 07/08/16 Page 7 of 8 PageID #: 669 Approximate Period of Treatment:-- --------------- - ~ttach additional pages as needed to identify other health ca.re providers you have seen. AUTHORIZATIONS Provide ONE (1) SIGNED ORIGJNAL copy of eaoh of the records authorization forms attaohed as Ex. A. These authorization forms will authorize the records vendor selected by the parties to obtain those records identified in the authorizations from the providers identified with.in this Plaintiff Profile F onn. VERlFICATION l, b1.J::>c~ 'f;>aad-aw s 1;£1 • declare under penalty of perjury subject to all applicable laws, that l have carefully reviewed the final copy of this . .Plaintiff Profile Fonn dated / p_,ftt /Q_ and verified that all of the information provided is true and correct to the best of my knowledg~ infonnation and belief. Sworn and subscribed before me This _ _/p_ day of~ 20 I-:> .. .- 5 Please Initial _fJI!_ POCZTOWSKID PPF 00006 Case 2:12-cv-01470 Document 62-5 Filed 07/08/16 Page 8 of 8 PageID #: 670 EXHIBIT F Redacted pursuant to Fed. R. Civ. P. 5.2 and PTO 11 Case 2:12-cv-01470 Document 62-6 Filed 07/08/16 Page 1 of 3 PageID #: 671 PRIVILEGED AND HIGHLY CONFIDENTIAL INFORMATION Patient: Debra Pocztowski Records Provider: Advocate Lutheran General Hospital (Medical Records Department) 1775 Dempster Street Medical Records, 3rd Floor South Park Ridge, IL 60068 847 -723-8265 Records Obtained: 03/3012013 231962.008.0089 - 231962.008.0838 POCZTOWSKID ALGH MDR00089 - POCZTOWSKID ALGH MDR01568 - - - - Records provided by: The Marker Group 13105 Northwest Fwy Houston, TX 77040 713-460-9070 PDF version generated on 03/31120 13 (NWFOO 10) 750 pages plus cover sheet PRIVILEGED AND HIGHLY CONFIDENTIAL INFORMATION Case 2:12-cv-01470 Document 62-6 Filed 07/08/16 Page 2 of 3 PageID #: 672 I" Jan ' 3 0, 2 0 0 7 6: 2 9 A Ivl L G H P P ~ C' liD I" I r /, I Tr "T ". A , \ \ \1\\ \\ 1\\ \\ 1\1 \\ 1\\ \\ \\\\\ \\\ \1 \\\ 1\ \\\ \\ \1\ \\ 1\\ \ \1\\ DAS 0 0 . ~A,.!vocate POCZTOWSKI,DEBRA 050Y F , eLu:~,bcnm GeneraJFJospitaJ NOONE, HICHAEL 1956 01 ;~~;~61~~CW:: \\\\\\\\1\1\\\\\1\ Outp,atient Day o'f Surgery " I~ 0 ) 8 24 P 17 0158374 ' ~ ~ /31/20 07 \\\\\\\\\\\\\\1\\\\1\1 .' -:;-r;, . 'Cvk.rff U r2itJWrs:k- ~ . .- . 1. Allergl,~s A)K~~ - 2. consent for: S'lL~~ - ~~;: 3. Antibiotics: ,4tv(s - - ~ :r:r 'tb}./ }(Il.. Ll , , .- 4. Antieml)olytic devlce5 5. Additional orders: - - .• ..i,' -~~- 6. Special discharge ins1 Medications: ~Ij(') (" fjoJ:c ~ "'""..,u, lit: ?'l;SAteoal m:n te- n v ,~,~,.e~'fng:-- MaY~bathe" J Activity: /-1,0 {.. ~ ~ Restricti~ns; ND - ! Other: -- Make apPointmer.t to ~ -- "" I Date Nurse Hours Orders I ';7)(_ ,;::( . I '-./t--c ,> , -= ;~ dl/L krh. <\;/'/ ~A?U -13. ~K1'J.i;~ ""/ U .J 1 3o!?;y "+- .t?-; hv-". ... ft:./w' ~r rtnr:r V "- I' " .... I '\ " ... " ... 1,,1 ructions for outpatients: h: :('" Sh NC-7 fcut\e' A 1:J I -/ /.3 ir::e Dr. days .' .~ 1[20 a !J~ YY'Vr1 '( 1 I -u .". vi!) L I~ I 0 fOr tJ. r "- p' , .. ... ::/i~ , , ::.:~/I'W ~on - \... --" Physic ian Signature: -" , ~\:> ~ I ! t---\~~ ~@/i~ :.,. ) V~S5~ J C:) .. I\) QQtJ ... !9yt ,"- I 914750 ;;/0::; @ 1002 Advo="" Hdtr. c"~" REDACTED REDACTED Case 2:12-cv-01470 Document 62-6 Filed 07/08/16 Page 3 of 3 PageID #: 673 EXHIBIT G Redacted pursuant to Fed. R. Civ. P. 5.2 and PTO 11 Case 2:12-cv-01470 Document 62-7 Filed 07/08/16 Page 1 of 3 PageID #: 674 PRIVILEGED AND HIGHLY CONFIDENTIAL INFORMATION Patient: Debra Pocztowski Records Provider: Illinois Urogynecology 1875 Dempster Street, Suite 665 Park Ridge, IL 60068 847 -825-1590 Records Obtained: 07/0612015 231962.016.0080 - 231962.016.0173 POCZTOWSKID ILLUR MDR00080 - POCZTOWSKID ILLUR MDR00173 - - - - Records provided by: The Marker Group 13IOS Northwest Fwy Houston, TX 77040 713-460-9070 PDF version generated on 07/06/20 IS(NWFOO 10) 94 pages plus cover sheet PRIVILEGED AND HIGHLY CONFIDENTIAL INFORMATION Case 2:12-cv-01470 Document 62-7 Filed 07/08/16 Page 2 of 3 PageID #: 675 ; ---- ------ . . UIO&}~· C'~ ..... I' .. rbide Cater tmDtmpslflSttmSutt.rw· rlllkRidp.IUlXl68· rt.w 5$7.1$.1590· F.tl U7JlS.ICiM "'/dud D, NM\ M;D. MicNd .. NeroIw. Wt o March 10, 1999 Oregory Lee. M. D. 1440 Northwest Highway. #200 Park Ridge, IL 60068 Re: Debra Pocztowstd MRN Dear Doctor Lee: Thank you for referral of your patient, Debra Poc%(owski. As you know, she was referred for the problem of urinary incontinence. The patient has had a problem with urinary incontinence for approximately 18 years since the birth of her second child, this being the second of her three vaginal deliveries. There was mild orgasm-related detrusor instabilitJ that has not been an actiYe problem as she is not currently sexually actiyc. She has daily urinary incontinence with even minimal activities. Tody's exam shows stress incontinence with urethral hypermobility 1 and we cotreeled this • problem completely with an INTROL bladder neck support prosthesis. I believe this lest of a .' pessaq win "be very effective in correcting her incontinence, and overall I think for the Jong- J 0 term she would make an optimal surgical candidate ror eompletecorrection. Certainly we will optimize nonsurgical options in this patient, and 1 will see her again in one week's time for early follow-up of h~r pessary use. Thank you for the referral of this.kind patient. 1 will keep you informed of her progress. - Sincerely t Mi::t.f1.~ MBN:hssIm Dictated/Not Read - .... POCZTOWSKID ILLUR MDR00142 REDACTED Case 2:12-cv-01470 Document 62-7 Filed 07/08/16 Page 3 of 3 PageID #: 676 EXHIBIT H Redacted pursuant to Fed. R. Civ. P. 5.2 and PTO 11 Case 2:12-cv-01470 Document 62-8 Filed 07/08/16 Page 1 of 3 PageID #: 677 PRIVILEGED AND HIGHLY CONFIDENTIAL INFORMATION Patient: Debra Pocztowski Records Provider: Illinois Urogynecology 1875 Dempster Street, Suite 665 Park Ridge, IL 60068 847 -825-1590 Records Obtained: 07/0612015 231962.016.0080 - 231962.016.0173 POCZTOWSKID ILLUR MDR00080 - POCZTOWSKID ILLUR MDR00173 - - - - Records provided by: The Marker Group 13IOS Northwest Fwy Houston, TX 77040 713-460-9070 PDF version generated on 07/06/20 IS(NWFOO 10) 94 pages plus cover sheet PRIVILEGED AND HIGHLY CONFIDENTIAL INFORMATION Case 2:12-cv-01470 Document 62-8 Filed 07/08/16 Page 2 of 3 PageID #: 678 c..~ Centt, • PooHlsSdc> C'enlft 1m 0m\psIt'tSUwt.Stlltt6U • Pad.~I1.6Q')63 • 1!hw.,7,m.1590 • filS W.m.I6CN ~GcIud D. ~tacft. M.D. )'1kNII IS. NOItM:. ltD. ! March 18. 1999 Gregory tee, M.D. 1440 Northwest Highway t #200 Park Ridge, It 60068 Re: Debra POC%tows1Q o MRN . . . . . .. . ·d Dear Doctor tee: This letter is to give you interim fonow-up on your patient, Debra Pocztowski. As you know. she was here for urinary incontinence. At her last visit we placed an INTROL bladder neck support prosthesis. This gave her the number one benefit of relief of dysfunctional voiding pain not actively described at her first visit. The patienl has an obstruclive {cRsalion of voiding that I beUeverelates to her marked urethrovesica1 junction and hypermobility, and this pessary allowed for urethral support and com(onable voiding. ~. . ... It did bring about l reduction in her urinary incontinence but she still has some mild occasional urge- inconanence and stress incontinence. At this time we will remove her pessary as she does not want to continue it (or the time being. have her continue pelvic Hoor muscle rehabilitation with Kegel contractions per our protocol. and she wiU undergo a trial of Dittopan XL Smg to be used once a day to see how this will reduce her urge incontinence symptoms as weU as her overall incontinence problem. I wiD see her again it' four weeks' time. Thank you for the referral of this kind patient. Since:~~~ . Mich:1ct B .. Noone., M.D~ MBN:hsslm Dictated/Not Read POCZTOWSKID ILLUR MDR00143 REDACTED Case 2:12-cv-01470 Document 62-8 Filed 07/08/16 Page 3 of 3 PageID #: 679 EXHIBIT I Case 2:12-cv-01470 Document 62-9 Filed 07/08/16 Page 1 of 13 PageID #: 680 Bruce A. Rosenzweig, M.D. Golkow Technologies, Inc. Page 1 1 IN THE UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF WEST VIRGINIA AT CHARLESTON 2 3 ------------------------- ) Master File No. IN RE: ETHICON, INC., ) 2:12-MD-02327 4 PELVIC REPAIR SYSTEM ) PRODUCTS LIABILITY ) MDL 2327 5 LITIGATION ) ------------------------- ) JOSEPH R. GOODWIN 6 THIS DOCUMENT RELATES TO ) U.S. DISTRICT JUDGE THE FOLLOWING CASES IN WAVE ) 7 2 OF MDL 200: ) DEBRA POCZTOWSKI, ) 8 Plaintiff, ) Case No. ) 2:12-cv-01470 9 -vs- ) ) 10 ETHICON, INC., ET AL., ) ) 11 Defendants. ) ) 12 ------------------------- ) 13 14 Deposition of BRUCE A. ROSENZWEIG, M.D., 15 pursuant to Rule 26, called by the Defendants for 16 examination, taken pursuant to the Federal Rules of 17 Civil Procedure of the United States District 18 Courts pertaining to the taking of depositions, 19 taken before CORINNE T. MARUT, C.S.R. No. 84-1968, 20 Registered Professional Reporter and a Certified 21 Shorthand Reporter of the State of Illinois, at the 22 offices of Wexler Wallace LLP, Suite 3300, 55 West 23 Monroe Street, Chicago, Illinois, on May 26, 2016, 24 commencing at 1:46 p.m. Case 2:12-cv-01470 Document 62-9 Filed 07/08/16 Page 2 of 13 PageID #: 681 Bruce A. Rosenzweig, M.D. Golkow Technologies, Inc. Page 25 1 A. No. 2 Q. Do you have any opinion that Dr. Noone 3 lacked the expertise to perform the TVT procedure 4 on Ms. Pocztowski? 5 A. As I state in my report, Dr. Noone's 6 treatment met the standard of care. His 7 preoperative evaluation of the patient met the 8 standard of care. His implant procedure was 9 performed within the standard of care. There was 10 no evidence of surgeon error or deviation from the 11 procedural steps. There was no evidence of 12 surgical complications. 13 Q. You do not include opinions in your 14 report that there was something wrong with 15 Dr. Noone's decision to use TVT with 16 Ms. Pocztowski, right? 17 MR. FAES: Object to form. 18 BY THE WITNESS: 19 A. I do not find Dr. Noone's decision to 20 use the TVT unreasonable. 21 BY MS. COOK: 22 Q. Dr. Noone made a risk/benefit decision 23 that TVT was appropriate for Ms. Pocztowski in 24 2004, correct? Case 2:12-cv-01470 Document 62-9 Filed 07/08/16 Page 3 of 13 PageID #: 682 Bruce A. Rosenzweig, M.D. Golkow Technologies, Inc. Page 26 1 MR. FAES: Object to form. 2 BY THE WITNESS: 3 A. Correct. 4 BY MS. COOK: 5 Q. Do you disagree with that conclusion? 6 A. As I stated before, Ms. Pocztowski was 7 an appropriate candidate for a surgical treatment 8 to treat her stress urinary incontinence. 9 Q. Do you disagree with the decision that 10 Dr. Noone made that the benefits of TVT outweighed 11 the risks for Ms. Pocztowski? 12 MR. FAES: Object to form. 13 BY THE WITNESS: 14 A. I do not have any criticism of Dr. Noone 15 for making the -- or drawing the conclusion that 16 the risks of the or the benefits of the TVT 17 outweighed the risks of the TVT in 2004 when he 18 implanted it in Mrs. Pocztowski. 19 BY MS. COOK: 20 Q. Do you know why Dr. Noone decided to use 21 TVT with Ms. Pocztowski? 22 A. Since I have not read his deposition, I 23 do not know why he decided to use the TVT in 24 Mrs. Pocztowski. Case 2:12-cv-01470 Document 62-9 Filed 07/08/16 Page 4 of 13 PageID #: 683 Bruce A. Rosenzweig, M.D. Golkow Technologies, Inc. Page 27 1 Q. Is it your opinion that Dr. Noone should 2 not have used any polypropylene mesh with 3 Ms. Pocztowski? 4 A. In 2004? 5 Q. Yes. 6 MR. FAES: Object to form. A little late 7 but... 8 BY THE WITNESS: 9 A. The only polypropylene that he used on 10 Mrs. Pocztowski was with the TVT. 11 BY MS. COOK: 12 Q. Right. 13 A. And I am not critical of his decision to 14 use the TVT back in 2004. It was not unreasonable 15 for him to use the TVT back in 2004. 16 Q. You don't give opinions in your report 17 about mechanical-cut versus laser-cut mesh with 18 respect to Ms. Pocztowski, do you? 19 MR. FAES: Object to form. 20 BY THE WITNESS: 21 A. I do not. 22 BY MS. COOK: 23 Q. You do not know what Dr. Noone knew 24 about the risks of TVT before implanting it in Case 2:12-cv-01470 Document 62-9 Filed 07/08/16 Page 5 of 13 PageID #: 684 Bruce A. Rosenzweig, M.D. Golkow Technologies, Inc. Page 40 1 to her stopping being sexually active in 2006. 2 Q. Did you see any complaints of vaginal 3 pain after that? 4 A. After 2006? 5 Q. Yes. 6 A. She was complaining of pelvic pain in 7 April of 2013, April 1, April 5. When I saw her on 8 April 14, 2016 she described that she had vaginal 9 discomfort before she stopped having intercourse. 10 On exam. 11 Q. And where are you reading from now? 12 A. From the top of page 9. Currently she 13 is not sexually active and has not been sexually 14 active since 2006. She did have some vaginal pain 15 before stopping having intercourse. She has an 16 occasional shooting pain inside of her vagina. 17 Her main problem is urinary urgency. 18 She has difficulty initiating her urinary stream 19 and she has frequent urinary tract infections. 20 Q. So, if I understand what you said, just 21 to make sure I get a straight answer. At least 22 sitting here today, you're not planning on giving 23 an opinion that she is suffering from dyspareunia 24 from the TVT, correct? Case 2:12-cv-01470 Document 62-9 Filed 07/08/16 Page 6 of 13 PageID #: 685 Bruce A. Rosenzweig, M.D. Golkow Technologies, Inc. Page 41 1 MR. FAES: Object to form. 2 BY THE WITNESS: 3 A. Correct. 4 BY MS. COOK: 5 Q. And you are not opining that the TVT 6 caused any erosion, extrusion or exposure, correct? 7 A. Correct. 8 Q. You agree that there is no evidence of 9 extrusion, erosion or exposure of the TVT with 10 Ms. Pocztowski, correct? 11 A. When I examined her, I felt that the 12 sling was palpable through a very thin level of 13 epithelium on the left side. So, it is my opinion 14 with a reasonable degree of medical probability 15 that her sling is in the process of 16 extruding/eroding through the vaginal mucosa. 17 Q. Do you have any idea how long it will be 18 before that happens? 19 A. More likely than not within one to two 20 years. 21 Q. And she's had the TVT in place for 12 22 years now, correct? 23 A. Correct. 24 Q. When you examined her you found no Case 2:12-cv-01470 Document 62-9 Filed 07/08/16 Page 7 of 13 PageID #: 686 Bruce A. Rosenzweig, M.D. Golkow Technologies, Inc. Page 45 1 January 2007 to remove a Gore-Tex suture from her 2 vaginal wall, correct? 3 A. Correct. 4 Q. You do not claim that any complication 5 related to her Gore-Tex suture was caused by the 6 TVT, do you? 7 A. Correct. 8 Q. Are there any findings from your 9 personal examination of Ms. Pocztowski in 10 April 2016 that you intend to use to support your 11 opinions that are not described in your report? 12 A. What I found is that the mesh was 13 palpable. It was the process of eroding through 14 the vagina. It was only covered by a thin layer of 15 epithelium. Because it was palpable, it was 16 contracted and deformed, roped, curled. 17 And so these are the findings that I 18 found at the day that I examined her, April 14, 19 2016. 20 Q. Do you say anything in here about how 21 you found that her mesh was roped or curled? 22 A. It was palpable. 23 Q. Did you specifically -- were you 24 specifically able to tell that it was roped or Case 2:12-cv-01470 Document 62-9 Filed 07/08/16 Page 8 of 13 PageID #: 687 Bruce A. Rosenzweig, M.D. Golkow Technologies, Inc. Page 46 1 curled? 2 A. Well, it shouldn't be palpable unless 3 it's contracted, roped or curled. 4 Q. Do you know specifically whether it was 5 roped? 6 A. It was contracted and deformed because 7 it was palpable, which is -- one of the processes 8 of deformation is roping, curling or folding. 9 Q. But you can't say sitting here today to 10 a reasonable degree of medical certainty that 11 Ms. Pocztowski's mesh is roped, correct? 12 MR. FAES: Object to form, asked and answered. 13 BY THE WITNESS: 14 A. It was palpable through a thin layer of 15 epithelium meaning that it had undergone 16 contraction and deformation. Part of that 17 deformation process is roping, curling or folding. 18 BY MS. COOK: 19 Q. And you say that part of the process is 20 roping, curling or folding and what I'm just trying 21 to understand is you can't say that it was one of 22 those three versus the other, right? 23 MR. FAES: Object to form. 24 BY THE WITNESS: Case 2:12-cv-01470 Document 62-9 Filed 07/08/16 Page 9 of 13 PageID #: 688 Bruce A. Rosenzweig, M.D. Golkow Technologies, Inc. Page 47 1 A. Correct. 2 BY MS. COOK: 3 Q. One of the injuries -- well, withdrawn. 4 When you saw Ms. Pocztowski, did you 5 tell her that she needed to have her mesh removed? 6 A. I did not offer any medical opinions. I 7 did not share any of my medical findings with 8 Ms. Pocztowski on the day that I examined her. 9 Q. Do you intend to tell her that? 10 A. I have not entered into a doctor-patient 11 relationship with Mrs. Pocztowski. 12 Q. Is it your opinion that Ms. Pocztowski's 13 mesh should be removed now, as soon as possible? 14 A. It is my opinion with a reasonable 15 degree of medical probability that Ms. Pocztowski 16 is going to continue to evolve into a full 17 thickness mesh erosion or extrusion due to the 18 contraction, degradation, chronic foreign body 19 reaction that is going on with the mesh, the 20 cytotoxicity that is leading to the cells around it 21 to die and will ultimately require a surgical 22 procedure to treat it. 23 Q. Do you think she needs to have that 24 surgery now? Case 2:12-cv-01470 Document 62-9 Filed 07/08/16 Page 10 of 13 PageID #: 689 Bruce A. Rosenzweig, M.D. Golkow Technologies, Inc. Page 48 1 MR. FAES: Object to form. 2 BY MS. COOK: 3 Q. Or do you think she should wait? 4 A. More likely than not she can wait until 5 there is the full epithelial extrusion. 6 Q. The opinions that you have given about 7 the contraction and deformation of the mesh and 8 cytotoxicity, are those all based on being able to 9 palpate her mesh when you examined her? 10 MR. FAES: Object to form. 11 BY THE WITNESS: 12 A. Palpation and the finding that it was -- 13 had already extruded through the majority of the 14 wall of the vagina. 15 BY MS. COOK: 16 Q. And that was all based on your personal 17 exam of her, though, right? 18 A. Correct. 19 Q. Have you seen anything in the medical 20 records that indicated that any other healthcare 21 provider found that her mesh was about to extrude 22 through her wall? 23 A. Not that I specifically recall in the 24 medical records. Case 2:12-cv-01470 Document 62-9 Filed 07/08/16 Page 11 of 13 PageID #: 690 Bruce A. Rosenzweig, M.D. Golkow Technologies, Inc. Page 84 1 leading to mesh contraction and deformation. 2 Q. And that's all based on your exam and 3 feeling that you were able to palpate the mesh, 4 correct? 5 A. Correct. 6 Q. So, the opinions that you give about 7 chronic foreign body reaction, deformation, roping, 8 cording, curling, fibrotic bridging, shrinkage, 9 contraction, degradation, are all of those based 10 solely on your ability on exam to palpate the mesh? 11 A. Being contracted, folded and eroding 12 through the layers of the vagina, yes. 13 Q. And is there any other evidence of any 14 of those things other than your own exam of 15 Ms. Pocztowski? 16 A. Not that I specifically recall, from 17 reviewing the medical records. 18 Q. Do you have any evidence that the 19 specific TVT product that was implanted in 20 Ms. Pocztowski differed from the manufacturing 21 specifications of the TVT? 22 A. No. 23 Q. On page 14 of your report at the bottom, 24 you say, "Moreover, because Ethicon had knowledge Case 2:12-cv-01470 Document 62-9 Filed 07/08/16 Page 12 of 13 PageID #: 691 Bruce A. Rosenzweig§ M.D. l r~ CORINNE T~ MARUT, C.S.R. No. 84-1968, 2 Registered Professicnal Reporter and Certified Shorthand Reporter, do hereby certify: 3 That previous to the com.'Uencement of the examination of the witness 1 the witness was duly 4 sworn to testify the whole truth concerning the matters herein; 5 That the foregoing deposition transcript was reported stenographically by me, was thereafter 6 reduced to typewriting under my personal direction and constitutes a true record of t:he testimony 7 given and the proceedings had; That the said deposition was taken a before me at the time and place specified; That the reading and signing by the 9 witness of the deposition transcript was agreed upon as stated herein; 10 11 12 13 14 15 15 17 That I am not a relative or employee or attorney or counsel; nor a relative or employee of such attorney or counsel for any of the parties hereto 1 nor interested directly or i.ndirectly in the outcome of this action~ It was requested before completion of the deposition that the witness, BRUCE A. ROSENZWEIG, M~D., have the opportunity to read and sign the deposit io;n. t. ranscri pt . ti ~ 1 f J {J ~ .5Zi . . ~¥~~ CORINNE T. Ml'>~RUT, Certified Reporter (The foregoing cen:ification of this 18 transcript does not apply to any reproduction of the same by any means, unless under 19 the direct control and/or supervision of the certifying reporter.} 20 . 21 I~~ ! 24 Golkow Technologies, Inc. Page 94 Case 2:12-cv-01470 Document 62-9 Filed 07/08/16 Page 13 of 13 PageID #: 692 EXHIBIT J Case 2:12-cv-01470 Document 62-10 Filed 07/08/16 Page 1 of 3 PageID #: 693 PRIVILEGED AND HIGHLY CONFIDENTIAL INFORMATION Patient: Debra Pocztowski Records Provider: Illinois Urogynecology 1875 Dempster Street, Suite 665 Park Ridge, IL 60068 847 -825-1590 Records Obtained: 0212212013 231962.016.0002 - 231962.016.0079 POCZTOWSKID ILLUR NIDR00002 - POCZTOWSKID ILLlJR rvIDR00079 - - - - Records provided by: The Marker Group 13105 Northwest Fwy Houston, TX 77040 713-460-9070 PDF version generated on 02122120 13 (NWFOO 10) 78 pages plus cover sheet PRIVILEGED AND HIGHLY CONFIDENTIAL INFORMATION Case 2:12-cv-01470 Document 62-10 Filed 07/08/16 Page 2 of 3 PageID #: 694 , Debra Pocztowski 12-16-04 REASON FOR VISIT: The patient is here on referral for a complaint of urgency and moderate incontinence. The patient has a history of vaginal hysterectomy and bilateral salpingo-oophorectomy and modified McCall's uterosacral ligament suspension of the vaginal apex, TVT pubovaginal sling for menorrhagia and uterine prolapse as well as stress incontinence. This was done May 12,2004. Subjectively, the patient feels that she is very pleased with her surgical result and confident that she can delay a void to a degree that she fInds satisfactory. There is no stress incontinence, despite occasional problems with the need for a rigorous cough.. She reported 10 her primary care physician a degree of urinary urgency with occasional urge loss en route to the bathroom particularly when she is near the bathroom with a very full bladder. No fever, chills, sweats, nausea, vomiting, constipation. diarrhea, neck pain, chest pain, back pain, or flank pain. Two or three urinary tract infections have been treated since May by her general practitioner. The patient is on Lasix for Jeg edema Allergies are none. -•. - Medications are furosemide, potassium, multi\l itamin, and calcium. Past medical, surgical, social, OB/GYN history unchanged from the admission history and physical of May 12, 2004. Physical exam is detailed on the chart. There is no significant pelvic organ prolapse and optimal pelvic support and negative cough stress test at 570 as well as at 550 cc. The patient voided one hour prior to the visit, and bladder volume was 570 cc_ A simple cystometrogram was then perfonned in the supine position with 50 mL aliquots of sterile saline. The first sensation was at 30 ce, first urge at 150 cc, strong desire at 350 ce, fullness at 450 cc, and maximum cystometric capacity at 550 cc. The patient voided 563 mL after this test, indicative of optimal voiding v.ith a negligible post·void residual and an average flow rate of 13.2 mLisec. IMP: Urge incontinence, overactive bladder, mild. Objectively improved bladder capacity with no stress or urge incontinence since the preop urodynamic. P: I believe the patient will do well at restoring urge control with pelvic floor physical therapy or a trjal of medication. She has elected a trial of Detrol LA 4 mg daily, and we will use this for 3 months and then stop. I \l,oill see her again in.3 months just to check on her progress. A detailed discussion regarding the urodynamic findings, the pelvic support findings. Overall, the patient is very much improved from a functional status compared to before her surgery in May of 2004. Michael B. Noone, M.D. MB~~~'/ cc: Dr. Kristin Dolling Dr. Lazar POCZTOWSKID_ILLUR_MDR00023 Case 2:12-cv-01470 Document 62-10 Filed 07/08/16 Page 3 of 3 PageID #: 695 EXHIBIT K Redacted pursuant to Fed. R. Civ. P. 5.2 and PTO 11 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 1 of 30 PageID #: 696 PRIVILEGED AND HIGHLY CONFIDENTIAL INFORMATION Patient: Debra Pocztowski Records Provider: Plaintiff Fact Sheet Records Obtained: 01/21/2016 231962.026.0001 - 231962.026.0028 POCZTOWSKID PFS 00001 - POCZTOWSKID PFS 00028 - - - - Records provided by: The Marker Group 13105 Northwest Fwy Houston, TX 77040 713-460-9070 PDF version generated on Ol/21/2016(NWF0010) 28 pages plus cover sheet PRIVILEGED AND HIGHLY CONFIDENTIAL INFORMATION Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 2 of 30 PageID #: 697 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA CHARLESTON DIVISION IN RE: ETHICON, INC. PELVIC REPAIR SYSTEM PRODUCTS LIABILITY LITIGATION THIS DOCUMENT RELATES TO Civil Action No.: 2:12-cv-01470 MDLNo.2327 Debra Pocztowslki Name of Plaintiff PLAINTIFF FACT SHEET Each plaintiff who allegedly suffered injury as a result of a pelvic mesh product manufactured or sold by Ethicon, Inc. must complete this Plaintiff Fact Sheet. In completing this Fact Sheet, you are under oath and must answer every question and provide information that is true and correct to the best of your knowledge. If you cannot recall all of the details requested, please provide as much information as you can and then state that your answer is incomplete and explain why as appropriate. If you select an ''I Don't Know11 answer, please state all that you do know about that subject. If any infonnation you need to complete any part of the Fact Sheet is in the possession of your attorney, please consult with your attorney so that you can fully and accurately respond to the questions set out below. If you are completing the Fact Sheet for someone who cannot complete the Fact sheet herself, please answer as completely as you can. The Fact Sheet shall be completed in accordance with the requirements and guidelines set forth in the applicable Case Management Order. A completed Fact Sheet shall be considered interrogatory answers pursuant to Fed. R. Civ. P. 33 and 34 and will be governed by the standards applicable to written discovery under Fed. R. Civ. P. 26 through 37. You must supplement your responses if you learn that they are incomplete or incorrect in any material respect. The questions and requests for production contained in the Fact Sheet are non- objectionable and· shall be answered without objection. This Fact Sheet shall not preclude Defendants from seeking additional documents and information on a reasonable, case~by-case basis pursuant to the Federal Rules of Civil Procedure and as permitted by the applicable Case Management Order. In filling out this form, please use the following definition: "healthcare provider" means any doctor, physician, surgeon, pharmacist, hospital, clinic, center. physician's office, infirmary, medical or diagnostic laboratory, or other facility that provides medical care or advice, and any pharmacy; x-ray department, radiology department, laboratory, physical therapist or physical therapy department, rehabilitation specialist, chiropractor, or other persons or entities involved in the diagnosis, care and/or treatment of you. 1 POCZTOWSKID PFS 00001 ..~ Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 3 of 30 PageID #: 698 In filling out this form, the terms "You" or "Your" refer to the person who received pelvic mesh product(s) manufactured or sold by Ethicon, Inc. and who is identified in Question L 1 (a) below. To the extent that the form does not provide enough space to complete your responses or answers, please attach additional sheets as necessary. I. BACKGROUND INFORMATION 1) Please state: a. Full name of the person who received the pelvic mesh product(s)~ including maiden name: Debra Ann Fucarino Pocztowslkj b. Ful1 name of the person completing this fOnTI, if different from the person listed in 1 (a) above, and the relationship of the person completing this form to the person listed in 1 (a) above: C. The name and address of your primary attorney: PhilliQs Law Offices, 161 N. Clark. Suite 4925, Chicago, IL 60601 2) Your Social Security Number: .60=--_____________ _ 3) Yourdateofbirth:;:..!,9/~2 :S=6 ___________________ _ 4) Your current residence address: River Grove, IL If you have lived at this address for less than 10 years; provide each of your prior residence addresses from 2000 to the present: , Chicago, A l'OX. June 2005 to May 2011 2 POCZTOWSKID PFS 00002 REDACTED REDACTED REDACTED REDACTED REDACTED REDACTED Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 4 of 30 PageID #: 699 REDACTED REDACTED REDACTED REDACTED REDACTED REDACTED REDACTED REDACTED REDACTED REDACTED REDACTED 5) Have you ever been married? Yes X No_ If yes, provide the names and addresses of each spouse and the inclusive dates of your marriage to each person. Edward Pocztowski (Deceased). Married 8/21177 6) Do you have children? Yes X No_ If Yes, please provide the following infonnation with respect to each child: Edward Salvatore Pocztowski Robert Bruce Pocztowski Biological Biological 7) Identify the name and age of any person who currently resides with you and their relationship to you: Not applicable. 8) Identify all secondary and post-secondary schools you attended, starting with high school and please provide the following information with respect to each: Maine East High School 2601 Dempster St., Park Ridge, IL 60068 Approx. 1970 to 1974 High Schoo! High School Diploma 9) Please provide the following information for your employment history over the past 10 years up until the present: Advocate Lutheran Genera] Hos ital 2025 Windsor, Oak Park, II 60523 1775 Dempster St, Park Rid e, IL Patient accounts; Medicare Biller 3 POCZTOWSKID PFS 00003 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 5 of 30 PageID #: 700 I 6oo6s ~: I I 112013 10) Have you ever served in any branch of the military? Yes _ No X If Yes, please provide the following information: a. Branch and dates of service, rank upon discharge and the type of discharge you received: ~~--------~~~~~--~~~~~~~-- b. Were you discharged from the military at any time for any reason relating to your medical, physical, or psychiatric condition? Yes_ No_ If Yes, state what that condition was: --~~-------------- 11) Within the last ten years, have you been convicted of, or plead guilty to, a felony and/or crime of fraud or dishonesty? Yes_ No_.K If Yes, please set forth where, when and the felony and/or crime: 4 POCZTOWSKID PFS 00004 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 6 of 30 PageID #: 701 II. CLAIM INFORMATION l) Please complete the following chart for each implanted Ethicon, Inc. pelvic mesh product. Insert additional lines as necessary. Product No, 1: TVT Device 8I-0041B, EO Pl5805; LOT 1145731 On or about May 12, 2004 Stress urinary incontinence and pelvic organ prolapse. Please see medical records for more specific details. Michael B. Noone, M.D. 1875 Dempster St #665, Park Ridge, IL 60068 2) F ot each pelvic mesh product identified above, describe your understanding of the medical condition for which you received the pelvic rnesh product(s): My conditions included pelvic organ prolapse and stress urinary incontinence. My medical records contain further details of the medical specifics and medical issues. 3) For each Ethicon, Inc. pelvic mesh product identified above, indicate if, prior to implantation,, you received any written and/or verbal information or instructions, including any risks or complications that might be associated with the use of the product(s)? Yes X No_ Don't Know_ If Yes: a. Provide the date you received the written and/or verbal information or instructions: I received infonnation and instructions when Dr. Noone discussed the procedure with me, which was sometime prior to the procedure. b. Identify by name and address the person(s) who provided the information or instructions: Michael B. Noone, M.D., 1875 Dempster St #665, Park Ridge, IL 60068 c. What information or instructions did you receive? Generally, the information I received was that the mesh procedure would help with my symptoms. I was advised that it was a safe procedure and not terribly invasive. Certain risks were discussed, such as the general risks of surgery/implantation. d. If you have copies of the V\fl'itten information or instructions you received, please attach copies to your response. 4) For each Ethicon, Inc. pelvic mesh product(s) that remains implanted in you: a. Has any doctor recommended removal of the pelvic mesh product( s )? 5 POCZTOWSKID _ PFS 00005 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 7 of 30 PageID #: 702 Yes No XUnsure. If Yes, Identify by name and address the doctor who recommended removal and state your understanding of why the doctor recommended removal: My implanting doctor Michael B. Noone, M.D., 1875 Dempster St #665, Park Ridge, IL 60068 recommended sur__gery because I was having issues including pain, recurrent infections. chronic bladder inflammation. Please see my medical records for more specific details. 5) Have any of the Ethicon, Inc., pelvic mesh product(s) been removed, in whole or in part? Yes No Don't Know X If Yes, for each pelvic mesh product removed provide: a. On what date; where and by whom (doctor) was the pelvic mesh product(s), or any p01tion of it, removed? On or about 1131/2007, Advocate Lutheran General Hospital, by Michael Noone. M.D. b. Explain why you consented to have the pelvic mesh product(s), or any portion of it; removed? Because I was suffering and in pain c. Does any medical treater, physician or anybody else on your behalf have possession of any portion of the pelvic mesh product® that was previously implanted in you and removed? Yes_ No_ Don't Know X If Yes, please state name and address of the person or entity having possession of same. 6) Do you claim that you suffered bodily injuries as a result of the implantation of any Ethicon, Inc.; pelvic mesh product(s)? Yes X No_ If Yes: a. Describe the bodily injuries, including any emotional of psychological injuries, that you claim resulted from the implantation of the pelvic mesh product(s). Generally, I suffer pain and suffering, including but not limited to vaginal pain, pelvic pain, painful intercourse, urinary problems including hyperactive bladder, bowel problems, constant infections. including both bladder infections and urinary tract infections. vaginal fistula, perforated vaginal wall. As a result of my injuries I generally cannot travel even short distances in a car (for example,_ to my work which is 14 miles from my home) without having to stop to use the bathroom. I also suffer disfigµrernent, disability and loss of a normal life. medical expenses, both past and future. I need access to a restroom at all times, which limits my ability to spend time with my friends and family including my 6 POCZTOWSKID _ PFS 00006 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 8 of 30 PageID #: 703 grandchildren,. For example, I cannot take my grandchildren to the park without there being a nearby restroom. These are just a few examples of my injuries and damages and are not intended to be all.inclusive. If asked I will be able to expand these in further detail. My medical records and health care providers can explain better than I can about the relationship of these problems to my mesh. b. When is the first time you experienced symptoms of any of the bodily injuries you claim in your lawsuit to have resulted from the pelvic mesh product(s)? I began to experience some of these symptoms approximately one year so after the 2004 implant smgery. Please refer to my medical records for the specific dates. I did not know the cause of these symptoms at that time or that my issues arose from the mesh product at that time. c. When did you first attribute these bodily injuries to the pelvic mesh product(s)? In approximately September 2011. I first made the connection when a coworker showed me a Chicago Tribune Newspaper article from July 2011 entitled "Some women didn't know of risks. says mesh left physical. emotional scars.') d. To the best of your knowledge and recollection, please state approximately when you first saw a health care provider for each of those bodily injuries you claim to have experienced relating to the pelvic mesh product(s): I began seeing my doctors for my gynecological related issues in approximately 2005. Please see my medical records for the more specific details. e. Are you currently experiencing symptoms related to your claimed bodily injuries? Yes X No If Yes, please describe your current symptoms in detail Generally. I suffer pain and suffering, including but not limited to vaginal pain, pelvic pain, painful intercourse, urinary problems including hyperactive bladder. bowel problems, constant infections, including both bladder infections and urinary tract infections, vaginal fistula, perforated vaginal wall. As a result of my injuries I generally cannot travel even short distances in a car (for example, to my work which is 14 miles from my home) without having to stop to use the bathroom. I also suffer disfigurement. disability and loss of a normal life, medical expenses, both past and future. I need access to a restroom at all times. which limits my ability to spend time with my friends and family including my grandchildren. For example, I cannot take my grandchildren to the park without there being a nearby restroom. These are just a few examples of my injuries and damages and are not intended to be all-inclusive. If asked I will be able to expand these in further detail. My medical records and health care providers can explain better than I can about the relationship of these problems to my mesh. 7 POCZTOWSKID _PFS 00007 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 9 of 30 PageID #: 704 f. Are you currently seeing, or have you ever seen a doctor or healthcare provider for each of the bodily injuries or symptoms listed above? Yes _ No_ If Yes, please list all doctors you have seen for treatment of any of the bodily injuries you have listed above. Kristin Do11ing, M.D. 1875 Dempster, Suite 245, Park Ridge, IL 60068 Daniel Lazar, M.D. 6131 Dempster St., Morton Grove, IL 60053 Jane Bang, M.D. 2800 N Sheridan Rd #101, Chicago, IL 60657 Bruce Bernheim, M.D. 1775 Ballard Rd, Park Ridge, IL 60068 Jeffrey Norris, M.D. 900 Rand Rd #120, Des Plaines, IL 60016 Gordon Gluckman, M.D. 900 Rand Rd # 120, Des Plaines, IL 60016 Robert Sulkowski, M.D. 7900 N Milwaukee Ave #222, Niles, IL 60714 Gynecological related issues including pain, infections, urina1y problems. Please see medical records for more s ecific details. Gynecological related issues including pain. infections) urinary problems. Please see medical records for more s edfic details. Gynecological rebted issues including pain, infections, urinary problems. Please see medical records for more s ecific details. Gynecological related issues including pain, infections, urinary problems. Please see medical records for more s ecific details. Gynecological related issues including pain, infections, urimuy problems. Please see medical records for more s ecific details. Gynecological related issues including pain; infections, urinary problems. Please see medical records for rnore s ecific details. Gynecological related issues including pain, infections; urinary problems. Please see medical records for more s ecific details. Gynecological related issues including pain, infections, urinary problems. P1ease see medical records for more s ecific details. 8 Approx. 2004 to 2007 Approx. 2004 to 2005 Approx. 2005 to present Approx. 2007 Approx. 2006 Approximately after 2004. Please refer to records for specific dates. Approximately after 2004. Please refer to records for specific dates. Approximately after 2004. Please refer to records for specific dates. POCZTOWSKID _ PFS 00008 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 10 of 30 PageID #: 705 g. Were you hospitalized at any time for the bodily injuries you listed above? Yes X No If Yes, please provide the following: .. · ... ____ ;, ··--~ ... : Advocate Lutheran General Hospital 1775 Dempster St Park Ridge, IL 60068 Advocate Lutheran Genera\ Hospital 177 5 Dempster St Park Rid e, IL 60068 Vaginal suture granuloma/foreign body from previous uterosacral suspension; recurrent urinazy tract infection, chronic bladder inflammation Diverticular disease Approx. 9/2007 7) Other than the Ethicon, Inc. pelvic mesh product(s) that are the subject of your lawsuit, have you been implanted with any other pelvic mesh products? Yes No X If Yes, please provide the following infonnation: a. Product Name(s): ---------------------- b. Date of implantation procedure(s) and name and address of implanting doctor(s): c. Condition(s) sought to be treated through placement of the device(s): d. Whether the product(s) remain implanted inside of you today? Yes No 8) Are you making a claim for lost wages or lost earning capacity? Yes NoX 9 POCZTOWSKID _ PFS _ 00009 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 11 of 30 PageID #: 706 If Yes, state the annual gross income you derived from your employment for each year, beginning five years prior to the implantation of the pelvic mesh product(s) until the present: 9) Are you making a claim for lost out-of-pocket expenses? Yes NoX If Yes~ please identify and itemize all out-of-pocket expenses you have incurred: 10) Has anyone filed a loss of consortium claim in connection with your lawsuit regarding the pelvic mesh product(s)? Yes No X If Yes, identify by name and address the person who filed the loss of consortium claim, state the relationship of that person to you, and state the nature of the claim: 11) Please indicate whether the consortium plaintiff is alleging any of the claimed damages set forth below and itemize the alleged damageslexpenses: Not a licable Not applicable Not a licable 10 POCZTOWSKID _PFS _ 00010 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 12 of 30 PageID #: 707 12) Please list the name and address of any healthcare providers the consortium plaintiff has seen for treatment for any physical~ emotional, or psychological injuries or symptoms alleged to be related to the loss of consortium claim. Not applicable. 13) Have you or anyone acting on your behalf had any communication, oral or written~ with any of the defendants or their representatives, other than your attorneys? Yes No X Don't Know If Yes, set forth the date of the communication, the method of communication, the name of the person with whom you communicated, and the substance of the communication between you and any defendants or their representatives: III. MEDICAL BACKGROUND 1) Provide your current age: 22_.Height 5'3" Weight 2501bs 2) At the time you received each pelvic mesh product(s), please state: Your age 48 Your approximate weight 180 lbs 3) State number of vaginal births you have had? "'""3 ___________ _ 4) State the number of cesarean section births you have had? _,.N~o=n=e'------- 5) In chronological order, list any and all surgeries; procedures, or hospitalizations you had in the IO year period BEFORE implantation of the pelvic mesh product(s); identifying by name and address the doctor(s), hospital(s) or other healthcare provider(s) jnvolved with each surgery or procedure; and providing the approximate date(s) for each. Insert additional rows as necessary. 11 POCZTOWSKID _PFS _ 00011 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 13 of 30 PageID #: 708 Michael B. Noone, M.D., 1875 Dem ster St #665, Park Rid e, IL 60068 Kristin Dolling, M.D. 1.875 Dempster, Suite 245, Park Ridge, IL 60068 Hysterectomy/prolapse; please see medical records for details Hysterectomy/prolapse; please see medical records for details Approx. 2004 Approx. 2004 6) In chronological order, list any and all surgeries, procedures, or hospitalizations you had AFTER the implantation of the pelvic mesh product(s); identifying by name and address the doctor(s\ hospital(s) or other healthcare provider(s) involved with each surgery or procedure; and provide the approximate date(s) for each. Insert additional rows as necessary. Robert Sulkowski, M.D. Gordan Gluckman, M.D. Low anterior resection and mobilization Approx. 7900 N Milwaukee Ave #222, Niles, lL 60714 of splenic flexure. Placement of ureteral 9126/2007 stents. Flexible s1gmoidoscopy x2. Please see medical records for details. Michael B. Noone, M.D., 1875 Removal of vaginal apex suture and Dempster St #665, Park Ridge, IL 60068 Cystoscopy. Please see medical records for details. Joubin Khorsand, M.D. Inguinal hernia repair. Please see 8901 GolfTe1Tace #305, Des Plaines, IL medical recmds for details. 60016 12 Approx. 1/31/2007 Approx. 11 /2009 POCZTOWSKID _PFS _ 00012 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 14 of 30 PageID #: 709 7) To the extent not already provided in the charts above, provide the name, address, and telephone number of every doctor, hospital, or other health care provider from which you have received medical advice and/or treatment for the past 10 years. Insert additional rows as necessary. North Suburban Surgical Consultants Doctors of the N orthshore Women's Health Specialists Illinois Urogynecology Advocate Lutheran General Hos ital 7900 North Mi1waukee Approx. in past 10 years Avenue, Suite 222 Niles, IL 60714 6131 W. Dempster St.i Approx. in past IO years Morton Grove, II 60053 1875 Dempster St., Suite Approx. in past 10 years 245 Park Rid e; IL 60068 1875 Dempster Str., Suite Approx. in past 10 years 665, Park Ridge,IL 60068 1775 Dempster St. Approx. in past 10 years Park Rid e, IL 60068 8) Please describe your physical activities associated with daily living, physical fitness, household tasks, and employment-re1ated activities before the implantation of each pelvic mesh product. Prior to the implantation of the pelvic mesh product 1 was active and engaged in physical, social and family-related activities. For example, I would go to the health club almost daily and cleaned by house on a daily basis. These are iust a few examples. 9) Please describe your physical activities associated with daily living, physical fitness, household tasks, and employment-related activities after the implantation of the pelvic mesh product(s). As a result of my injuries my life has completely changed. For example, generally I cannot travel even short distances in a car (e.g. when driving to my work which is 14 miles from my home) without having to stop to use the bathroom. I need access to a restroom at all times, which limits my ability to spend time with my friends and family including my grandchildren. For example, I cannot take my grandchildren to the park without having a nearby restroom. 10) To the best of your knowledge, have you suffered from any of the following: 13 POCZTOWSKID _PFS_00013 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 15 of 30 PageID #: 710 Yes Yes - Adhesions No../ - Pre Post No - -- Bleeding or Clotting Disorders Yes./ Yes./ Pre./ Post If Yes, please specify No No -- - disorder: Bowel Obstruction Yes - Yes Pre Post - No./ No - ~ - Bowel Perforation Yes,/ Yes - Pre Post./ No No -- Cancer If Yes, please specify Yes Yes Pre Post - - No./ No - -type: - Chronic Constipation Yes ~ Yes Pre Post - No./ No - -- Collagen Yes Yes Pre Post - -Disorder/Deficiency No./ No - -- Connective Tissue Disorder Yes - Yes No - Pre Post If Yes, please specify - No - - Unknown -disorder: Crohn's Disease, Irritable Bowel Syndrome, Ulcerative Colitis~ or Chronic Diarrhea Yes Yes - - Pre Post No./ No - -If Yes, please specify - which condition and treatment prescribed: Cystocele Yes./ Yes./ Pre ,/ Post ./ No No - 14 POCZTOWSKID PFS 00014 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 16 of 30 PageID #: 711 REDACTED Diabetes Yes Yes Pre Post Nov" No Diverticulitis Yes./ Yes Pre Post./ No No Dyspareunia Yes../ Yes Pre Post./ No No Enterocele Yes Yes Pre Post No./ No Fistulas Yes./ Yes./ Pre Post./ No No Hernias Yes./ Yes_:/_ Pre Post _L No No Hypertension or High Yes./ Yes../ Pre Post _i_ Blood Pressure No No Hypotension or Low Yes .j Yes./ Pre Post./ Blood Pressure No No Immune System Disease or Dysfunction including HIV I AIDS If Yes~ please specify condition: Malnutrition Yes Yes Pre Post No./ No Muscle or Muscle~ Wasting Disorder Yes Yes Pre Post ff Yes, please specify No./ No disorder: Neuromuscular Disease or Disorder Yes Yes Pre Post If Yes, please specify No,/ No disorder: Obesity Yes./ Yes Pre Post./ No No Pelvic Trauma Yes Yes Pre Post No,/ No 15 POCZTOWSKID PFS 00015 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 17 of 30 PageID #: 712 If Yes, please describe trauma: Pelvic Tum ors or Yes - Yes - Pre Post Fibroids No No - -- - Peritonitis/Sepsis Yes Yes Pre Post - - No/ No - -- Rectocele Yes J Yes./ Pre../ PostL No No Recurrent or Chronic Vaginal or Bladder Infections If Yes, please specify Yes./ Yes./ Pre Post J No No -location and nature of - - infections: Recurrent Vaginal Pain lf Yes, please Yes J Yes../ Pre Post./ No No -describe the nature of - - pain experienced: Urinary Incontinence Yes../ Yes./ Pre ..j Post ./ No No ~ - Yes - Yes Urinary Retention No - Pre Post - No - ~ Unsure - Yes - Yes Uterine Prolapse No - Pre Post - No - - Unsure - Vaginal Vault Yes Yes - No - Pre Post Prolapse - No - -Unsure - Wound Healing Problems If Yes, please Yes - Yes Pre Post - No./ No - ~ explain: - 16 POCZTOWSKID _PFS_00016 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 18 of 30 PageID #: 713 Any other disease of ' ' the gut, intestines, or Yes./ Yes bowels No - Pre Post./ No -- - If Yes, please specify condition (s): 17 POCZTOWSKID PFS 00017 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 19 of 30 PageID #: 714 *************** THE FOLLOWING QUESTIONS ARE CONFIDENTIAL AND SUBJECT TO THE PROTECTIVE ORDER APPLICABLE TO THIS CASE. a) Were you diagnosed with and/or treated for Sexually Transmitted Diseases for the five year period prior to the implantation of the pelvic mesh product(s) through the present? If Yes, specify the disease, date of onset, medication/treatment, treating physician and current status of condition: b) Have you heen diagnosed with and/or treated for any alcohol or chemical dependency for the one year prior to the implantation of the pelvic mesh product(s) through the present? If Yes, specify type and time period of dependency, type of treatment received, name of treatment provider, and current status of condition: c) Have you experienced, been diagnosed with or been treated for any mental health conditions including depression, anxiety or other emotional or psychiatric disorders in tbe 5 year period before implantation of the pelvic mesh product(s) through the present? If Yes, specify condition, date of onset, medication/treatment, treating pbysician and current status of condition: REDACTED REDACTED REDACTED REDACTED REDACTED REDACTED REDACTED Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 20 of 30 PageID #: 715 *************** 11) Have you experienced menopause? Yes../ No If Yes, at what age did it begin? """"A""p~pr°"'o""'x;.;.... =ag;>.'eo...4.;..;8~~-----~~-~~-~~ 12) Have you undergone vaginal estrogen therapy, ho1mone therapy, or systemic estrogen replacement therapy CERT)? Yes _;L_ No If Yes, please provide the type of therapy you received, date(s) of the therapy, and the name and address of the healthcare provider providing the therapy. Hormone therapy 13) Do you now or have you ever smoked tobacco products? Yes ./ No If Yes: a) How long have/did you smoke? Approx. 35 years 14) List each prescription medication you have taken for more than 3 months at a time, within the last 5 years prior to implant to present, giving the name and address of the phannacy where you received/filled the medication, the reason you took the medication, and the approximate dates of use. Please see phannacy records for details 19 POCZTOWSKID PFS 00019 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 21 of 30 PageID #: 716 REDACTED IV. INSURANCE INFORMATION I) Provide the following information for any past or present medical insurance coverage within the last 10 years: 2) Have you ever been denied life insurance for reasons relating to your health? Yes No./ Don't Know If Yes, please state when the denial occurred, the name of the life insurance company, and the company's reason for denial:--------------- 3) To the best of your knowledge; have you been approved to receive or are you receiving Medicare benefits due to age; disability, condition or any other reason or basis? Yes No -I If Yes, please specify the following: a) The date on which you first became eligible: ---------- [Please note: if you are not currently a Medicare-eligible beneficiary, but become eligible for Medicare during the pendency of this lawsuit, you must supplement your response at that time. This information is necessary for all parties to comply with Medicare regulations. See 42 US.C. .l 395y(b)(8), also known as Section 111 of the Medicare, Medicaid and SCHIP Extension Act of 2007 and 42 U.S.C J 395y(b)(2) also known as the Medicare Secondary Payer Act.) 20 POCZTOWSKID _ PFS _ 00020 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 22 of 30 PageID #: 717 V. PRIOR CLAIM INFORMATION 1) Have you filed a lawsuit or made a claim in the last 10 years, other than in the present suit relating to any bodily injmy? Yes No./ If Yes, please specify the following: a) Court in which suit/claim filed or made:~------------- b) Case/Claim Number: ______________ ~----- c) Nature ofClaimJlnjury: ___________________ _ 2) Have you applied for workers~ compensation (WC), Social Security disability (SSI or SSD) benefits. or other state or federal disability benefits within the past 1 O years? Yes No,/ If Yes, please specify the following: a) Date (or year) of application:--------------- b) Type of benefits sought------------------- c) Agencyfinsurer from which you sought the benefits: _______ _ d) The nature of the claimed injury/disability: --------~---- e) Whether the claim was accepted or denied: ------------- 21 POCZTOWSKID _PFS _ 00021 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 23 of 30 PageID #: 718 VI. FACT WITNESSES l) Please identify all persons who you believe possess information concerning your injury(ies) and current medical conditions, other than your healthcare providers, and please state their name address and his/her/their relationship to you: Plaintiff is gathering this information and will seasonably su lement VII. IDENTIFICATION OF DOCUMENTS AND OTHER ELECTRONICALLY STORED INFORMATION For the period beginnjng three years prior to implantation of the pelvic mesh product(s) to present, please identify all research, including on-line research, you have conducted regarding the subjects of this litigation, including the implantation of the pelvic mesh product{s), the injuries and/or damages you claim resulted from the implantation of the pelvic mesh product(s), or your medical or physical condition. Identify date, time, and source, including any websites visited. Research conducted to understand the legal and strategic advice of your counsel is not considered responsive to this request. None other than what was discussed with my implanting doctor. VIII. DOCUMENT REQUESTS 1) RELEASES. NOTE: Please sign and attach to this Fact Sheet the authorizations for the release of records appended hereto. 22 POCZTOWSKID _PFS _ 00022 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 24 of 30 PageID #: 719 2) DOCUMENTS. State whether you have any of the following documents in your possession, custody~ and/or control. If you do, please provide a true and correct copy of any such documents with tlris completed Fact Sheet. a) If you were appointed by a court to represent the plaintiff in this lawsuit, produce any documents demonstrating your appointment as such. i. Not Applicable I ii. The documents are attached--~ [OR] I have no documents ___ _ b) If you represent the estate of a deceased person in this lawsuit, produce a copy of the decedent,s death certificate and autopsy report (if applicable). I. Not Applicable.../ ii. The documents are attached-~- [OR] I have no documents ___ _ c) Produce any communications (sent or received) in your possession, which shall include materials accessible to you from any computer on which you have sent or received such communications, concerning the pelvic mesh product(s) or subject litigation) including but not limited to all letters, e-mails, biogs, Facebook posts, tweets, newsletters, etc. sent or received by you. Research conducted to understand the legal and strateg]c advice of your c01msel is not considered responsive to this request. i. Not Applicable __ n. The documents are attached ___ [OR] I have no documents__{ investigation continues d) Produce all documents (including journal entries, lists, memoranda, notes, diaries), photographs, video, DVDS or other media, including all copies, discussing or referencing the subjects of this litigation including the pelvic mesh product(s), the injuries and/or damages you claim resulted from the pelvic mesh product(s), or evidencing your physical condition from three years prior to the implantation of the pelvic mesh product(s) to present, including but not limited to the injuries for which you claim relief in this lawsuit. Research conducted to understand the legal and strategic advice of your counsel is not considered responsive to this request. L Not Applicable __ II. The documents are attached-~- [OR] I have no documents ___ _ 23 POCZTOWSKID PFS 00023 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 25 of 30 PageID #: 720 ./We are currently in the process of gathering them and will forward upon receipt e) Produce any pelvic mesh product packaging, labeling, advertising, or any other pelvic mesh product product-related items in your possession, custody or control. i. Not Applicable __ IL The documents are attached,/ [OR] I have no documents __ _ f) Produce all documents concerning any communication between you and the Food and Drug Administration (FDA) or between you and any employee or agent of the Defendants, regarding the pelvic mesh product(s) at issuei except as to those communications which are attorney client/work product privileged. i. Not Applicable __ ii. The documents are attached ___ [OR] I have no documents./ g) Produce all documents in your possession, custody or control evidencing or relating to any correspondence or communication between Ethicon, Inc., (or any of its related companies or divisions) and any of your doctors, healthcare providers, and/or you relating to the pelvic mesh product(s), except as to those communications which are attorney client/work product privileged. 24 POCZTOWSKID PFS 00024 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 26 of 30 PageID #: 721 i. Not Applicable __ 11. The documents are attached ___ [OR] I have no docmnents ___ _ ../Investigation continues. We are currently in the process of gathering them and will forward upon receipt. h) Produce any and all documents in your possession, custody or control reflecting~ describing, or in any way relating to any instructions or warnings you received prior to implantation of any pelvic mesh product(s) concerning the risks and/or benefits of your surgery, including but not limited to any risks andfor benefits associated with the pelvic mesh product(s). i. Not Applicable __ ii. The documents are attached ___ [OR] I have no documents __ _ ,/Investigation continues. We are currently in the process of gathering them and will forward upon receipt. i) Produce any and all documents reflecting the model nwnber and lot number of the pelvic mesh product(s) you received. 1. Not Applicable __ lL The documents are attached../ [OR] I have no documents __ _ j) lfyou underwent surgery to explant in whole or in part the pelvic mesh product(s) that you received: produce any and all documents in your possession~ custody or control aside from documents that may have been generated by experts retained by your counsel for litigation purposes, relating to any evaluation of the pelvic mesh product(s) and any other material that was (were) surgically removed from you. i. Not Applicable __ n. The documents are attached .J [OR] l have no documents __ _ k) If you claim lost wages or lost earning capacity, copies of your federal and state tax returns for the two years prior to implantation of the pelvic mesh product(s) to the present. L Not Applicable .J 25 POCZTOWSKID _PFS_00025 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 27 of 30 PageID #: 722 ll. The documents are attached ___ [OR] I have no documents--~ If you do not produce the required tax returns, you must provide fully completed authoriz.ations for the release of federal and state tax returns. l) All documents in your possession; custody or control concerning payment by Medicare on the injured party's behalf relating to the injuries claimed in this lawsuit~ including but not limited to Interim Conditional Payment summaries and/or estimates prepared by Medicare or its representatives regarding payments made on your behalf for medical expenses relating to the subject of this litigation. L Not Applicable __ ii. The documents are attached ___ [OR] I have no documents./ [Please note: if you are not currently a Medicare-eligible beneficiary, but become eligible for Medicare during the pendency of this lawsuit, you must supplement your response at that time. This information is necessary for all parties to comply with Medicare regulations. See 42 US. C. J 395y(b)(8), also known as Section IJ 1 of the Medicare, Medicaid and SCHIP Extension Act of 2007 and 42 U.S.C. l395y(b)(2) also known as the Medicare Secondary Payer Act.] 26 POCZTOWSKID _PFS_00026 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 28 of 30 PageID #: 723 VERIFICATION I, ~b l'a.. ?a?;? --)c.0.s,L, decla.l'e under penalty of pe1jury subject to all applicable laws, that I have carefully reviewed the final copy of this Plai11tiff Fact Sheet dated l ·\'S. ~ and verified that all of the infonnation provided is true and con-ect to the best of my knowledge, infonnation and belief. VERIFICATION OF LOSS OF CONSORTIUM I, bq brae '±1t?c...,?.-io.-_,.'):;/<;.a. declare under penalty of pe1jui·y subject to all applicable laws, that I have carefully reviewed the final copy of this Plaintiff Fact Sheet dated ---~:J "I. ·~. and verified that all of the infonnation provided is tme and correct to the best of my knowledge, info1mation and belief, D~~····· £. L 61< · ~c:> ,.. Slgnatur'.'.);::::;Um Plaintiff POCZTOWSKID _PFS_00027 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 29 of 30 PageID #: 724 IN THE UNITED STATES DISTRICT COURT SOUTHERN DISTRICT WEST VIRGINIA CHARLESTON DIVISION IN RE: ETHICON, INC., PELVIC REPAIR ) SYSTEM PRODUCTS LIABILITY LITIGATION ) ) ) ) ) ) MDL No.~ 2327 No. 2:12-cv-01470 Plaintiffs: Debra Pocztowski ) CERTIFICATE OF SERVICE I hereby certify that on January 19, 2016, I have served the foregoing Plaintiff Fact Sheet upon the following: ·······-·······-·-········=··········"""' . . ·············· "'························ ·-·-·····-·-························-··· Butler, Snow, O'Mara, Stevens & Cannada, PLLC : Thomas,Combs & Spann PLLC 1020 Highland Colony Parkway, Suite 1400 : 300 Summers Street, Suite 1380 ·Ridgeland, MS 39157; and •Charleston, WV 25301 by sending a copy of the same via email to Robyn Davis, RDavis@tcspllc.com, Jan Thomas. jan.thomas@butlersnow.com and copying Renee Baggett~ Rbaggett@awkolaw.com, Tom Cartmell, tcartmell@wcllp.com, Betsy Williams at Bwilliams@awkolaw.com, Sean Keith at SKeithC@,arkattomeys.com, Mason Boling at MBoling@arkattorneys.com, and Kitty Patterson at Kitty@arkattorneys.com before 5:00 p.m. on this 19th day of January. 2016. By: ls/Elise A. W aisbren Attorney for Plaintiff Stephen D. Phillips (ARDC # 6189372) Terrence M. Quinn (ARDC # 6275734) Elise A. Waisbren (ARDC # 6307256) PHILLIPS LAW OFFICES 161 N. Clark Street, Suite 4925 Chicago, IL 60601 (312) 346-4262 POCZTOWSKID PFS 00028 Case 2:12-cv-01470 Document 62-11 Filed 07/08/16 Page 30 of 30 PageID #: 725