Suter et al v. Johnson & Johnson et al

MOTION

S.D.W. Va.July 8, 2016

1 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA AT CHARLESTON Electronically Filed 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: Carol Suter and Troy Suter v. Ethicon, Inc. et al. Case No. 2:12-01712 DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT ******************************************************** Ethicon, Inc., Ethicon LLC and Johnson & Johnson (collectively, “Ethicon”), pursuant to Fed. R. Civ. P. 56, hereby move the Court for a summary judgment of no liability on each of the Plaintiffs’ claims alleging injury from a TVT mesh product used to treat Carol Suter’s symptoms of stress urinary incontinence. Ethicon is entitled to summary judgment because a number of Plaintiffs’ claims are time-barred and Plaintiffs cannot offer evidence to support the necessary elements of any of their claims. First, Plaintiffs’ negligence, product liability and loss of consortium claims are barred by the applicable statute of limitations. Claims based on injuries to the person of a plaintiff must be filed within one year from the date the cause of action accrues under Kentucky law. See KY. REV. STAT. § 413.140(1)(a). The record shows that Plaintiffs’ claims accrued more than one year prior to the filing of this action, and are time-barred. Case 2:12-cv-01712 Document 51 Filed 07/08/16 Page 1 of 4 PageID #: 303 2 Second, Ethicon is entitled to summary judgment on Plaintiffs’ claims of failure to warn. Under the learned intermediary doctrine, Ethicon’s duty to warn ran only to Ms. Suter’s implanting surgeon, Dr. John Patterson. In this case, any alleged failure to warn did not impact Dr. Patterson’s decision to recommend TVT because he already knew the risks associated with the product, and there is no evidence that a different warning would have changed his mind with respect to prescribing TVT to treat Ms. Suter’s stress urinary incontinence. Finally, Dr. Patterson warned Ms. Suter of the risks associated with the use of TVT. For these reasons, Plaintiffs cannot prevail on their failure to warn claims. Third, Plaintiffs’ design defect claims fail because Plaintiffs’ case-specific experts failed to offer testimony that a defect in the TVT was the probable cause of Ms. Suter’s alleged injuries. Plaintiffs also failed to offer proof of a feasible alternative design as is required under Kentucky law. Fourth, Plaintiffs’ manufacturing defect claim should be dismissed because there is no evidence that the TVT was not manufactured according to the manufacturer’s specifications as is required to support such a claim under Kentucky law. Fifth, Plaintiffs’ negligence claim fails to the extent it is based on an alleged failure to warn or an alleged design or manufacturing defect as Kentucky courts treat product liability claims the same whether pursued under a negligence or strict liability theory. Thus, Plaintiffs’ negligence claim should be dismissed for all the reasons previously noted. Sixth, Plaintiffs’ claim of a defective product is similarly duplicative of the other product liability claims and should be dismissed for the same reasons. Seventh, Plaintiffs’ fraud and misrepresentation claims fail as there is no evidence that Plaintiffs had any communication with Ethicon or relied on any statements made by Ethicon. Case 2:12-cv-01712 Document 51 Filed 07/08/16 Page 2 of 4 PageID #: 304 3 Finally, Troy Suter’s derivative loss of consortium claim fails for all the same reasons that Carol Suter’s claims are barred as a matter of law. For these reasons, Ethicon’s motion for summary judgment should be granted, and each of the Plaintiffs’ claims should be dismissed with prejudice. Respectfully submitted, /s/ Susan J. Pope Susan J. Pope FROST BROWN TODD LLC 250 West Main Street, Suite 2800 Lexington, KY 40507-1749 (859) 231-0000 spope@fbtlaw.com Christy D. Jones BUTLER SNOW LLP Renaissance at Colony Park 1020 Highland Colony Parkway, Ste. 400 P. O. Box 6010 Ridgeland, MS 39158-6010 (601) 948-5711 Christy.Jones@butlersnow.com David B. Thomas THOMAS COMBS & SPANN P.O. Box 3824 Charleston, WV 25338-3824 (304) 414-1800 dthomas@tcspllc.com COUNSEL FOR ETHICON, INC. AND JOHNSON & JOHNSON Case 2:12-cv-01712 Document 51 Filed 07/08/16 Page 3 of 4 PageID #: 305 4 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/ Susan J. Pope Counsel for Defendants 0000KIE.0632443 4830-2362-0916v2 Case 2:12-cv-01712 Document 51 Filed 07/08/16 Page 4 of 4 PageID #: 306 EXHIBIT A Case 2:12-cv-01712 Document 51-1 Filed 07/08/16 Page 1 of 17 PageID #: 307 Carol Ann Suter Golkow Technologies, Inc. - 1.877.370.DEPS Page 1 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF WEST VIRGINIA AT CHARLESTON IN RE: ETHICON, INC., Master File No. PELVIC REPAIR SYSTEM PRODUCTS 2:12-MD-02327 LIABILITY LITIGATION MDL 2327 JOSEPH R. GOODWIN U.S. DISTRICT JUDGE ______________________________________________________ CAROL & TROY SUTER, ET AL., Plaintiffs, v Case No. 2:12-cc-01712 ETHICON, INC., ET AL., Defendants. DEPOSITION FOR DEFENDANTS *** *** *** DEPONENT: CAROL ANN SUTER DATE: MARCH 23, 2016 *** *** *** Case 2:12-cv-01712 Document 51-1 Filed 07/08/16 Page 2 of 17 PageID #: 308 Carol Ann Suter Golkow Technologies, Inc. - 1.877.370.DEPS 8 (Pages 26 to 29) Page 26 1 Q. He's the youngest? Well, let's talk about 2 Christopher first, then. 3 Okay. When was Christopher born? 4 A. 5 Q. Did you have any problems with that 6 pregnancy? 7 A. I had to have a C-section. 8 Q. Okay. And why did you have to have a 9 C-section? 10 A. He was breech. 11 Q. Before you had the C-section, did any of the 12 medical professionals try to turn him while he was 13 still in your stomach? 14 A. No. He -- he was already turned. 15 Q. Well, did they try to reposition him so you 16 could have a vaginal delivery? 17 A. No. I don't think so. 18 Q. All right. They didn't push on your stomach 19 and try to get him to move around? 20 A. Well, maybe they did do that. 21 Q. Did you ever go into active labor with him 22 where you tried to push? 23 A. Yes. 24 Q. How long did that last? Page 27 1 A. Overnight. 2 Q. So, about how many hours? 3 A. I got there at -- probably like 11:00 at 4 night, and they took me in for a C-section at 7:34 the 5 next morning. 6 Q. How long did you try to push during that time 7 frame? 8 A. I was in constant labor all night, and he 9 just wouldn't turn. He just wouldn't budge. So when 10 the doctor came in, they said, "Prep her for 11 C-section." 12 Q. Okay. So, I just want to make sure I'm 13 understanding. 14 So, you were having labor pains during that 15 entire time, correct? 16 A. Yes. 17 Q. How much of that time were you actively 18 pushing and trying to deliver him vaginally? 19 A. I guess whenever it got -- whenever I felt 20 like I needed to push. 21 Q. Okay. But during that whole span of time 22 that was going on; is that -- 23 A. Yeah. 24 Q. -- fair to say? Page 28 1 A. Yes. 2 Q. Okay. I just wanted to make sure I 3 understood. 4 Did you have any other problems with that 5 pregnancy? 6 A. Nope. 7 Q. No gestational diabetes? 8 A. Nope. 9 Q. No high blood pressure? 10 A. Nope. 11 Q. No swelling of your legs? 12 A. Nope. 13 Q. He wasn't premature? 14 A. Nope. 15 Q. Any other bleeding or problems like that? 16 A. Nope. 17 Q. Okay. How much did he weigh? 18 A. 7.7 and a half. 19 Q. Seven pounds, 7 and a half ounces? 20 A. Yes. 21 Q. Did they ever use forceps when you were 22 trying to deliver him vaginally? 23 A. No. 24 Q. Were you ever put on bedrest when you were Page 29 1 pregnant with Christopher? 2 A. No. 3 Q. Did you have an epidural? 4 A. Yes. 5 Q. At what point? 6 A. When they took me in to do the C-section. 7 Q. Okay. Not before then? 8 A. No. 9 Q. Did you experience any vaginal tearing -- 10 A. No. 11 Q. -- with Christopher? 12 How long did you wait until you resumed 13 sexual intercourse after delivery? 14 A. Like eight weeks. 15 Q. Did you ever have any vaginal infections 16 after delivery? 17 A. No. 18 Q. Any other complications after delivery? 19 A. No. 20 Q. Did you do Kegel exercises after 21 childbirth? 22 A. I have no idea what that is. 23 Q. Okay. Those are exercises your doctor 24 sometimes tells you to do to restrengthen your vaginal Case 2:12-cv-01712 Document 51-1 Filed 07/08/16 Page 3 of 17 PageID #: 309 Carol Ann Suter Golkow Technologies, Inc. - 1.877.370.DEPS 9 (Pages 30 to 33) Page 30 1 muscles. 2 A. No. 3 Q. Okay. Let's talk about Allen. 4 When was he born? 5 A. 6 Q. And C-section again? 7 A. Yes. 8 Q. Did you ever go into labor with him? 9 A. No. 10 Q. Scheduled C-section? 11 A. Scheduled. 12 Q. Not premature? 13 A. No. 14 Q. All right. Did you have any complications 15 with him? 16 A. No. 17 Q. You know, during your pregnancy? 18 A. No. 19 Q. After delivery, did you have any 20 complications? 21 A. No. 22 Q. Any infections? 23 A. No. 24 Q. How long until you resumed sexual relations Page 31 1 after that? 2 A. Eight weeks. 3 Q. Okay. Any problems at that point? 4 A. No. 5 Q. How much did he weigh? 6 A. 6.4. 7 Q. All right. Do you know if you experienced 8 any scarring, any internal scarring, as a result of 9 either of your C-sections? 10 A. Not that I'm aware of. 11 Q. Do you have visible scarring -- 12 A. Uh-huh. 13 Q. -- as a result of your C-sections? 14 A. Yes. 15 Q. Can you describe those scars for us, please? 16 A. It's about that long (indicating), and goes 17 all the way across the bottom of my stomach. 18 Q. When you say the bottom of your stomach, can 19 you describe that a little more precisely? 20 A. My lower abdomen. 21 Q. Okay. If you were wearing, like, your 22 underwear, does it go below the line of your underwear 23 or -- 24 A. Right at the line of it. Page 32 1 Q. Okay. All right. I want to talk about your 2 education a little bit. 3 What's the highest grade or highest level of 4 education that you completed? 5 A. Eighth. 6 Q. Eighth grade? 7 A. Yes. 8 Q. Did you ever get a GED after that? 9 A. No. 10 Q. Can you read and write? 11 A. I can read and I can write, but it's hard for 12 me to understand what I read. 13 Q. Do you have to rely on others to read or 14 write for you? 15 A. To -- to explain things to me. 16 Q. Okay. Can you give me an example of the 17 things that you are able to read and understand? 18 I mean, like do you read books or magazines 19 for pleasure? 20 A. Yes. 21 Q. Okay. So, that's the kind of thing you do 22 not need someone else to explain to you -- 23 A. Right. 24 Q. -- right? Page 33 1 So, what types of papers or documents would 2 you need help with? 3 A. Like -- well, like my -- my legal papers. 4 Legal papers. 5 Q. Okay. Anything else? 6 A. No. 7 Q. Okay. Have you obtained any other education, 8 like vocational training or anything like that? 9 A. No. 10 Q. All right. Are you on any medications 11 today? 12 A. No. I didn't take anything today. 13 Q. Do you normally take medications? 14 A. Yes. 15 Q. Okay. Why didn't you take your medications 16 today? 17 A. I take it before I go to bed. I just took it 18 last night instead of taking it this morning. 19 Q. Okay. Did you take anything last night that 20 would impair your ability to testify today? 21 A. No. 22 Q. Okay. Can you tell me the list of 23 medications that you take regularly? 24 A. I take Prozac. Case 2:12-cv-01712 Document 51-1 Filed 07/08/16 Page 4 of 17 PageID #: 310 Carol Ann Suter Golkow Technologies, Inc. - 1.877.370.DEPS 22 (Pages 82 to 85) Page 82 1 surgery. That's it, I believe. 2 Q. Again, talking about your gynecological 3 history, when did you start menstruating? 4 A. I was 13. 5 Q. Did you have any problems with your 6 periods? 7 A. No. 8 Q. Not until you got immediately -- or not until 9 your -- immediately before your hysterectomy? 10 A. Right. 11 Q. Okay. Have you ever had any abnormal pap 12 smears? 13 A. No. 14 Q. What type of contraceptives have you used 15 over the years? 16 A. Condoms. 17 Q. Anything else? 18 A. No. 19 Q. Have you ever been on birth control pills? 20 A. Oh, yeah. I have been on birth control 21 pills. 22 Q. When? 23 A. When I was 15. 24 Q. Until when? Page 83 1 A. Well, that didn't do me no good. 2 And then I think I was put back on them after 3 that, but they made me sick, so I -- I couldn't take 4 them. 5 And then I just -- I -- I'm assuming that was 6 it. Just use, you know, condoms after that. 7 Q. So no patches or injections or anything like 8 that? 9 A. No. 10 Q. Have you ever been treated for a STD? 11 A. No. 12 Q. Have you gone through menopause? 13 A. I'm going through it now, I believe. 14 Q. When did that start? 15 A. Probably about four years ago. 16 Q. What types of symptoms are you experiencing 17 that you associate with menopause? 18 A. The night sweats, the hot/cold flashes, the 19 nervousness. 20 Q. Anything else? 21 A. I forgot. Dr. Mann is an OB/GYN, I've seen 22 her. 23 Q. When did you see her? 24 A. Like, 2014, maybe. She's the one that did a Page 84 1 couple of my surgeries. 2 Q. Okay. We will talk about that in a minute. 3 Thanks for pointing that out. 4 MS. HENSLEY: Do you need a switch tape? 5 THE VIDEOGRAPHER: We will go off the record 6 at the conclusion of blank number one at 10:20 a.m. 7 (There was a brief recess.) 8 THE VIDEOGRAPHER: We are back on the record 9 at beginning of blank number 2 at 10:36 a.m. 10 BY MS. HENSLEY: 11 Q. We were talking about your hysterectomy 12 before we took a break, so I just want to pick up 13 there. 14 What organs were removed during your 15 hysterectomy? 16 A. I'm pretty sure they did a complete except my 17 ovaries. 18 Q. Have you had any hormone therapy since you 19 had the hysterectomy? 20 A. They had me on pills for four months and then 21 just stopped. 22 Q. What kind of pills? 23 A. Just estrogen, I think is what it was. 24 Q. That was immediately after the Page 85 1 hysterectomy? 2 A. Yes. 3 Q. And they -- you haven't taken them since? 4 A. No. 5 Q. No other hormone replacement therapy? 6 A. No. 7 Q. Have you ever used estrogen vaginal cream? 8 A. No. 9 Q. All right. I want to talk about this 10 lawsuit. 11 So you live in Eminence, Kentucky, and your 12 lawyers are from Florida. 13 How do you find those lawyers? 14 A. Actually, I saw an ad on TV. 15 Q. When did you see the ad? 16 A. Probably a couple of years after I had it 17 done. 18 Q. So you had the surgery in March of 2008, 19 correct? 20 A. Yes. 21 Q. And so do you mean you saw the ad sometime in 22 2010? 23 A. Yes. 24 Q. And tell me about the advertisement that you Case 2:12-cv-01712 Document 51-1 Filed 07/08/16 Page 5 of 17 PageID #: 311 Carol Ann Suter Golkow Technologies, Inc. - 1.877.370.DEPS 23 (Pages 86 to 89) Page 86 1 saw. 2 A. It was just talking about vaginal mesh, a 3 lawyer advertising a thing about women that's had 4 vaginal mesh put in that had been recalled. 5 Q. What did you think when you saw that 6 advertisement? 7 A. Well, the problems I was having, it made me 8 think that maybe something was wrong with mine. 9 Q. Something wrong with your mesh? 10 A. Yes. 11 Q. And what problems were you having at that 12 time? 13 A. Bleeding. 14 Q. Okay. What else? 15 A. Painful sex. The -- the hurting, the 16 constant hurting in my stomach. 17 Q. When you say "in your stomach," do you mean 18 in your pelvic area? 19 A. In my pelvic area, yes. 20 Q. What else? 21 A. That's pretty much it, I guess. 22 Q. How often were you having bleeding? 23 A. Like every day, and I knew it wasn't right. 24 Q. How long had you been having that bleeding? Page 87 1 A. Probably within the first year after I had it 2 done, I noticed it. 3 Q. Did it gradually increase? 4 A. Yes. 5 Q. How long had you been having pain with sex? 6 A. From the first time after I had the surgery. 7 Q. And when was the first time you attempted sex 8 after the surgery? 9 A. Probably, it was almost three months. 10 Because I was just really -- I was just scared to even 11 try because I wanted to make sure I was healed and all 12 of that. 13 Q. And was sex painful every time? 14 A. Yes. 15 Q. What about the pelvic pain? When did it 16 start? 17 A. Like -- along with everything else, with the 18 bleeding and -- within the first year. 19 Q. How often did you feel pelvic pain? 20 A. It would -- it was just coming and going. 21 And just, I mean, I guess on a daily basis. 22 Q. Did the pelvic pain increase over time? 23 A. Yes. 24 Q. So back to this advertisement that you saw on Page 88 1 television. 2 Can you tell me any more specifics about what 3 the ad said? 4 A. No. I just seen a bladder mesh and I knew 5 that that's what I had done. And I thought that 6 something was wrong -- something was going on with me. 7 And I didn't know if that had anything to do 8 with that, and so that's when I called to find out. 9 Q. When do you think you saw the ad? You said 10 sometime in 2010, correct? 11 A. Yes. 12 Q. Do you remember when in 2010? 13 A. No. 14 Q. So what did you do after you saw the ad? 15 A. Well, I wrote the number down. Then 16 probably -- probably a week or two later, I just 17 kept -- kept having the problems, problems, problems. 18 So I said, "I'm just going to call and see if this is 19 what I'm going through." If it is, you know, kind of 20 like what I'm going through. 21 Q. So when you saw that ad, you believed that 22 what they were describing on the ad described the 23 problems that you were having? 24 A. Yes. Page 89 1 Q. And you believed that those problems were 2 associated with the mesh implant? 3 A. Yes. Till I didn't have it before I had it 4 put in. 5 Q. Were you scared when you saw the ad? 6 A. Yes. 7 Q. Were you mad when you saw the 8 advertisement? 9 A. No, I wasn't really mad. I was just, like, 10 just really concerned that if -- if that is something 11 that is not a good product and that's what is inside 12 of my body, what harm could it do to me. 13 And I wanted to find out if that's what it 14 was, because if that's what it was, I wanted it 15 gone. 16 Q. So you called the number from the 17 advertisement. 18 A. Yes. 19 Q. Were you put in contact with a lawyer's 20 office? 21 A. Yes. 22 Q. Was that lawyer's office the same one that is 23 representing you today? 24 A. Yes. Case 2:12-cv-01712 Document 51-1 Filed 07/08/16 Page 6 of 17 PageID #: 312 Carol Ann Suter Golkow Technologies, Inc. - 1.877.370.DEPS 25 (Pages 94 to 97) Page 94 1 the surgery, correct? 2 A. Yes. 3 Q. At that point, did you think there was 4 something wrong with the mesh? 5 A. I didn't know for sure if it was the mesh or 6 if was just tissue that was still real tender tissue 7 at the time, but then every time we tried after that, 8 it just was worse and worse and worse. 9 Q. When you began having problems with pelvic 10 pain within first year of the mesh surgery, when you 11 began experiencing symptoms of pelvic pain, did you 12 believe there was a problem with the mesh? 13 A. Yes. 14 Q. When you began having bleeding after the mesh 15 surgery in 2008, when you first experienced the 16 symptoms of bleeding, did you think there was a 17 problems with the mesh? 18 A. Yes. 19 Q. But you didn't seek treatment from 20 Dr. Patterson until sometime after that 21 A. No. I went to see him, like, three or four 22 different times, and that's when he was doing the 23 different tests. 24 He sent me to the hospital for one -- one -- Page 95 1 a couple of different times for different tests. And 2 then he did other kinds in the office, which put a 3 camera up into my bladder. 4 And then, I mean -- I kept telling him 5 something wasn't right. Something wasn't right. 6 Q. What was his response? 7 A. Nothing, really. He just kept doing all of 8 these different things trying to, I guess, figure out 9 what was going on. 10 And then when the bleeding actually got 11 worse, I went to my OB/GYN. And she is the one that 12 actually found the mesh erosion. 13 Q. So the OB/GYN is Dr. Mann? 14 A. Yes. 15 Q. Have you ever received any communication on 16 behalf of an insurance company advising you to 17 investigate a claim regarding your mesh device? 18 A. No. 19 Q. Have you ever received a communication from 20 any third party telling you about a possible claim 21 concerning your mesh device? 22 A. No. 23 Q. Have you ever received any unsolicited phone 24 calls, e-mails or other correspondence or Page 96 1 communication on pelvic mesh litigation? 2 A. No. 3 Q. Has any third party agreed to pay for your 4 expenses connected to this lawsuit? 5 A. No. 6 Q. Do you have health insurance? 7 A. Yes. 8 Q. Who is that through? 9 A. Medicare and Passport. 10 Q. How long have you been on Medicare? 11 A. Since my disability. 2003. 12 Q. If you recover a monetary judgment against 13 Ethicon in this lawsuit, does any company or 14 individual have a right to be paid from that judgment 15 before you are paid? 16 A. No. 17 Q. Okay. Just a few documents I want to show 18 you real quickly. 19 First, have you seen a copy of your 20 deposition notice? 21 A. I'm sure I have. I'm not sure what that 22 means... 23 (Exhibit No. 2 was marked for 24 identification.) Page 97 1 THE WITNESS: Oh, yes. I've seen this. 2 BY MS. HENSLEY: 3 Q. We will mark that as Exhibit 2. And if you 4 will look, Schedule A on Page 3 asks you to bring a 5 certain number of documents with you. 6 Did you bring any documents with you today? 7 A. No. 8 Q. Do you have any documents responsive to this 9 request that have not already been provided to us? 10 A. No. 11 Q. Okay. The next thing is the Complaint that 12 was filed on your behalf in this case. 13 (Exhibit No. 3 was marked for 14 identification.) 15 BY MS. HENSLEY: 16 Q. And we will mark this as Exhibit 3. 17 Have you seen the Complaint that was filed on 18 your behalf? 19 A. I'm not sure. I'm sure I have. 20 Q. Do you need a minute to look it over? 21 A. It is just pretty much about my -- about the 22 mesh, right? 23 Q. It is the complaint that was filed on your 24 behalf -- Case 2:12-cv-01712 Document 51-1 Filed 07/08/16 Page 7 of 17 PageID #: 313 Carol Ann Suter Golkow Technologies, Inc. - 1.877.370.DEPS 26 (Pages 98 to 101) Page 98 1 A. Yes. 2 Q. -- in this case? 3 A. Yes. 4 Q. Have you seen it before? 5 A. Yes. 6 Q. That Complaint is dated May 29, 2012, 7 correct? 8 A. Yes. 9 Q. Do you know if there was a written agreement 10 in place between yourself and your attorney as of May 11 29, 2012? 12 A. Is there what now? 13 Q. A written agreement, a contract, between you 14 and your attorney. 15 A. This one I'm assuming. 16 Q. No. Did you-all enter into an agreement, 17 your attorney and you, into a contract where they 18 would represent you in this case? 19 A. Yes. They are my attorneys. 20 Q. Did you have that agreement in place as of 21 May 29, 2012? 22 A. I -- I guess. 23 Q. You don't remember? 24 A. I don't remember. Page 99 1 MS. LARMOND-HARVEY: Ms. Hensley, we have a 2 copy of the contract if you need that. 3 MS. HENSLEY: The -- 4 MS. LARMOND-HARVEY: The contract with the 5 firm. 6 MS. HENSLEY: Okay. 7 THE WITNESS: I mean, I've been going through 8 this for years. I can't -- it's hard to keep up with 9 all this. 10 MS. HENSLEY: Okay. Thanks. Let's go off a 11 minute. 12 THE VIDEOGRAPHER: Off at 10:55 a.m. 13 (There was a brief recess.) 14 THE VIDEOGRAPHER: We are back on the record 15 at 10:57. 16 BY MS. HENSLEY: 17 Q. Your counsel has handed me a copy of your 18 contract entitled, "Authority to Represent and Fee 19 Agreement between Saunders & Walker PA." 20 Is this your signature on the last page, 21 Ms. Suter? 22 There are two places, I believe, for your 23 signature. One on Page 4 and another on the last 24 page. Page 100 1 A. Yes. 2 Q. Is that your signature? 3 A. Yes. 4 Q. Date of that agreement is September 8, 2011; 5 is that true? 6 A. Yes. 7 MS. HENSLEY: I would like to mark that as 8 Exhibit 4. 9 (Exhibit No. 4 was marked for 10 identification.) 11 BY MS. HENSLEY: 12 Q. Is that a true and accurate copy of the 13 contract that you entered into with your attorneys? 14 A. Yes. 15 Q. Yes? 16 A. Yes. 17 Q. Thank you. 18 Okay. Do you know who pays the expenses in 19 your case? 20 A. I'm not sure. I'm assuming my attorneys. 21 Q. The next thing that I want to show you is 22 your Plaintiff Profile Form. 23 (Exhibit No. 5 was marked for 24 identification.) Page 101 1 BY MS. HENSLEY: 2 Q. Can you take a look at this, please? 3 Have you seen that document before? 4 A. Pretty sure. 5 Q. And that is your signature on -- let me 6 see -- Page 6 of the document? 7 A. Yes. 8 Q. And you verified that the information 9 contained in that Plaintiff Profile Form is true and 10 accurate? 11 A. Yes. 12 Q. And you verified that under penalty of 13 perjury, correct? 14 A. Yes. 15 Q. You understand that our time today to depose 16 you is limited by court order, don't you? 17 A. What does that mean? 18 Q. That we only have a limited amount of time 19 that we are allowed to speak with you today. 20 Do you understand that? 21 A. Yes. 22 Q. So you understand that your answers have to 23 be accurate and truthful today? 24 A. Yes. Case 2:12-cv-01712 Document 51-1 Filed 07/08/16 Page 8 of 17 PageID #: 314 Carol Ann Suter Golkow Technologies, Inc. - 1.877.370.DEPS 31 (Pages 118 to 121) Page 118 1 sitting? 2 A. Standing up. 3 Q. Okay. How would that happen? 4 A. It just would come out. 5 Q. So did have you a sense -- 6 A. And then I would realize it and then run to 7 the bathroom. 8 Q. Did you have a sense of urgency before that 9 would happen when you were standing? 10 A. No. 11 Q. So you wouldn't have any feeling and you 12 would just lose urine? 13 A. Yes. 14 Q. And how often did happen before the 15 surgery? 16 A. Well, I mean, all the time. 17 Q. Okay. Before the surgery, Dr. Patterson did 18 an examination on you, correct? 19 A. Yes. 20 Q. Do you know what he found? 21 A. No. 22 Q. Do you know when you first spoke with 23 Dr. Patterson about using pelvic mesh for your stress 24 urinary incontinence? Page 119 1 A. I don't remember. 2 Q. Do you think this February 2008 visit might 3 have been the first time you discussed it? 4 A. I don't remember. 5 Q. Was anyone else with you on that visit? 6 A. No. 7 Q. Before your surgery, had you ever heard of 8 TVT or mesh before? 9 A. No. 10 Q. Had you ever heard of a sling before? 11 A. No, I didn't even know they could do that. 12 Q. Did you do any Internet research or any other 13 research about the TVT or mesh or sling before your 14 surgery? 15 A. No. 16 Q. Did you ever see the mesh before it was 17 implanted? 18 A. No. 19 Q. Did you ask Dr. Patterson to see it? 20 A. No. 21 Q. Did he ever recommend physical therapy to 22 you? 23 A. No. 24 Q. And he didn't recommend any other type of Page 120 1 surgery that did not involve mesh? 2 A. No. 3 Q. Did you have a discussion with Dr. Patterson 4 about the risks and benefits of mesh? 5 A. I don't remember. 6 Q. Did you have a discussion with Dr. Patterson 7 about the risks and benefits of the surgery that you 8 were about to undergo? 9 A. Oh, yeah. 10 Q. What -- tell me about that discussion. 11 A. I just asked him if it was a safe thing to 12 have done. I said, "I never heard of it before." 13 And he said that -- that women -- they do -- 14 they fix bladders all the time, is what he told me. 15 Q. Did he tell you about any specific risks 16 associated with the surgery? 17 A. No. 18 Q. Did you rely on any written or -- written 19 instructions regarding the surgery? 20 A. No. 21 Q. Did you receive any type of brochure on the 22 mesh material? 23 A. No. 24 Q. You understood that there were certain risks Page 121 1 associated with any surgery, didn't you? 2 A. Well, yeah, I mean, there is always a risk. 3 Q. And that includes a risk of infection? 4 A. I'm assuming. 5 Q. And bleeding? 6 A. I'm assuming. 7 Q. And even death? 8 A. I'm assuming. 9 Q. Did you understand that -- 10 A. Yes. 11 Q. -- at the time that you underwent the 12 surgery? 13 A. Yeah. 14 Q. I'm going to mark this as Exhibit 9. 15 (Exhibit No. 9 was marked for 16 identification.) 17 BY MS. HENSLEY: 18 Q. This is a consent form that you signed on 19 February 28, 2008. 20 A. My signature. 21 Q. That is your signature? 22 A. Yes, ma'am. 23 Q. Thank you. 24 And you recall consenting to that Case 2:12-cv-01712 Document 51-1 Filed 07/08/16 Page 9 of 17 PageID #: 315 Carol Ann Suter Golkow Technologies, Inc. - 1.877.370.DEPS 33 (Pages 126 to 129) Page 126 1 Q. -- that it would improve things? 2 And you understood there was a risk that 3 things may not improve? 4 A. Well, yeah. I mean, he didn't say that, but, 5 I mean, that's -- that's with everything, I'm sure. 6 Q. And you understood that all surgeries have 7 risks, true? 8 A. Yes. Yes. 9 Q. And one risk is bleeding, true? 10 A. I'm assuming. 11 Q. Did you know that -- well, do you understand 12 that all surgical treatment options for stress urinary 13 incontinence with or without mesh have possible 14 risks? 15 A. I didn't know that. 16 Q. Did you decide to have the mesh surgery on 17 recommendation of Dr. Patterson? 18 A. Yes. 19 Q. Is there anything else that influenced your 20 decision to have the mesh surgery? 21 A. No. 22 Q. Did you speak with anyone else about the 23 surgery before had you it? 24 A. No. Page 127 1 Q. Did you speak with your husband before you 2 had the surgery? 3 A. Yeah, I talked to my husband about it. 4 Q. Did he have any input or any opinion that he 5 gave you about whether you should or should not have 6 the surgery? 7 A. No. 8 Q. Did you do any independent research on 9 Dr. Patterson? 10 A. No. 11 Q. Did you ever get a second opinion as to 12 whether you should have a surgery with mesh? 13 A. No. 14 Q. Did you ask Dr. Patterson about his 15 experience with mesh? 16 A. I asked him if he performed the surgery. And 17 he told me yes. 18 Q. Did he say how many times? 19 A. Several times. 20 Q. If you would let me finish first before you 21 start talking. It just will make the record more 22 clear, please. 23 Did you talk with anyone else who had had 24 mesh implanted before your surgery? Page 128 1 A. No. 2 Q. And you didn't receive any written materials 3 about TVT from Dr. Patterson? 4 A. Not that I remember. 5 Q. So it is safe to say you did not rely upon 6 any brochure in making the decision to have mesh 7 surgery? 8 A. Right. 9 Q. What was your understanding of the procedure 10 that was performed on you? 11 A. That it was going to raise my bladder up and 12 stop the leakage. 13 Q. You understood that there was going to be a 14 synthetic product inserted in your body? 15 A. Yes. 16 Q. And you understood that the mesh was 17 permanent, correct? 18 A. Yes. 19 Q. And you -- we have already marked the consent 20 form that -- is that Exhibit 7 there? 21 A. Nine. 22 Q. Nine. Thank you. 23 And those are your initials? 24 A. Yes. Page 129 1 Q. And you said that was your signature on that 2 document, correct? 3 A. Yes. 4 Q. And you knowingly and voluntarily consented 5 to the procedure. 6 A. Yes. 7 Q. True? 8 A. Yes. 9 Q. And the consent form also indicates that you 10 "understood that the practice of medicine and surgery 11 is not an exact science and that you have received no 12 promises, warranties or guarantees with respect to the 13 benefit to be realized or consequences of the 14 aforementioned procedure." 15 Is that true? 16 A. Yes. 17 Q. At the bottom of the form, Dr. Patterson 18 certified that he has "...fully explained the nature, 19 purpose, alternatives, risks and potential 20 complications of the treatment and/or procedures 21 described, and after the foregoing information has 22 been explained, the patient or representative 23 consented to all treatment or procedures described." 24 Is that true? Case 2:12-cv-01712 Document 51-1 Filed 07/08/16 Page 10 of 17 PageID #: 316 Carol Ann Suter Golkow Technologies, Inc. - 1.877.370.DEPS 34 (Pages 130 to 133) Page 130 1 A. I guess. 2 Q. Why do you say -- 3 A. I signed it. I mean, I don't remember 4 everything that he told me. 5 If he told me and I signed it, then I guess 6 he told me. 7 Q. Okay. How did the surgery go? 8 A. It went fine, I thought. 9 Q. Were you released the same day? 10 A. Yes. 11 Q. Did you have a catheter when you were 12 released? 13 A. Yes. 14 Q. For how long? 15 A. Four days. 16 Q. Did you have any complications with the 17 catheter? 18 A. No. 19 Q. Did you receive discharge instructions? 20 A. Yes. 21 Q. What were those instructions? 22 A. After the fourth day, take it out. 23 Q. Take out the catheter? 24 A. Take the catheter out. Page 131 1 Q. Did you have any other instructions? 2 A. No. 3 Q. Were you to refrain from any specific 4 activities after the surgery? 5 A. No lifting, no sex, no, you know, just pretty 6 much recuperate from it. 7 Q. For how long? 8 A. I think it was, like, six weeks. 9 Q. Did you follow those instructions? 10 A. Yes. 11 Q. Did you have any other problems after the 12 surgery? 13 A. No. 14 Q. Did you follow up with Dr. Patterson's office 15 after the surgery as recommended? 16 A. Yes. 17 Q. Do you remember when you next saw 18 Dr. Patterson after the surgery? 19 A. It was, like, six or eight weeks. 20 Q. What happened at that point? What did he do 21 for you? 22 A. I don't remember. 23 Q. Did he do an examination? 24 A. I think so. Page 132 1 Q. Did he find any problems at that point in 2 time? 3 A. No. 4 Q. Were you experiencing any problems at that 5 point in time? 6 A. No. 7 Q. Do you recall when you next sought medical 8 treatment related to the mesh implant or any 9 incontinence problems? 10 A. I couldn't tell you. 11 Q. Do you think it could have been a couple of 12 years after that? 13 A. Well, like I said, I went back to him. And 14 then he did the -- where they filled up my bladder and 15 all of that and that nothing was -- nothing about it. 16 So then I just pretty much left it alone 17 until all of the other problems started, and then I 18 went to Dr. Mann. 19 Q. Okay. So you -- you would have seen -- the 20 next person you would have seen for any type of 21 urinary incontinence or pelvic pain or bleeding 22 problems would have been Dr. Patterson after your mesh 23 surgery? 24 A. Yes. Page 133 1 Q. Is there anybody else you would have seen 2 before you saw Dr. Patterson after the mesh surgery? 3 A. I don't think so. 4 Q. We have already talked about this a little 5 bit. 6 You had a CT of the brain performed on March 7 28, 2008, shortly after -- I'm sorry. 8 Let me mark this. This is Exhibit 11. 9 (Exhibit No. 11 was marked for 10 identification.) 11 BY MS. HENSLEY: 12 Q. Shortly after your mesh implant surgery. 13 Do you recall that? 14 A. I had a what? 15 Q. A CT of brain for headaches. 16 A. Right. Yes. 17 Q. We already talked about that, correct? 18 A. Yes. 19 Q. And then it looks like you returned to 20 Dr. Patterson in 2010 for treatment for urinary 21 incontinence and frequency of urination. 22 Does that sound accurate to you? 23 A. Yes. 24 Q. So no treatment for any type of urinary Case 2:12-cv-01712 Document 51-1 Filed 07/08/16 Page 11 of 17 PageID #: 317 Carol Ann Suter Golkow Technologies, Inc. - 1.877.370.DEPS 35 (Pages 134 to 137) Page 134 1 incontinence issues after your mesh surgery, so no 2 further treatment in 2008. 3 Does that sound accurate? 4 A. Yes. 5 Q. No treatment in 2009? 6 A. I guess not. 7 Q. But you were experiencing symptoms during 8 that -- 9 A. Yes. 10 Q. -- time. And we have already discussed 11 those, true? 12 I want to show you a record from 13 Dr. Patterson's office. We will mark it as Exhibit 14 12. 15 (Exhibit No. 12 was marked for 16 identification.) 17 BY MS. HENSLEY: 18 Q. This is dated June 3, 2010. 19 You need a minute? 20 A. Sure. 21 MS. HENSLEY: Let's go off record. 22 THE VIDEOGRAPHER: We'll go off record at 23 11:38 a.m. 24 (There was a brief recess.) Page 135 1 THE VIDEOGRAPHER: Back on the record. 2 BY MS. HENSLEY: 3 Q. So this record is dated June 3, 2010. 4 At that point in time, you had returned to 5 see Dr. Patterson, correct? 6 A. Yes. 7 Q. And your complaints at that point is 8 frequency of urination, which had been present for 9 several months. 10 Does that sound correct to you? 11 A. Yes. 12 Q. You had tried a medication called Toviaz, 13 T-O-V-I-A-Z? 14 A. Yes. 15 Q. And it says, "The frequency is better." 16 Do you recall that improving? 17 A. No. Actually, I don't. 18 Q. Okay. Do you just not recall it or do you 19 think that's not accurate? 20 A. I don't remember it improving because he -- 21 the -- I went back. And, I mean, he had me on the 22 medicine for, like, maybe three months. So, maybe 23 he -- maybe said it like that because I did try it for 24 three months, but then I couldn't tell a difference. Page 136 1 It was still coming out when it wasn't 2 supposed to come out. And I went back and I told him 3 that. And that's when we stopped the medication and 4 then he did the -- looked in my bladder and all of 5 that stuff. 6 Q. Do you recall him wanting you to do a 7 urodynamic study, but that had to be taken -- that had 8 to take place in Lexington? 9 A. Yes. 10 Q. Why wouldn't you go to Lexington for that 11 study? 12 A. I couldn't get up here. 13 Q. Why not? 14 A. I didn't have away to get up here, and I 15 don't drive like that. And there is just no way I 16 could have came up here. 17 Q. What do you mean when you say you "don't 18 drive like that"? 19 A. In big cities, I just don't drive in big 20 cities. 21 Q. Do you drive in Louisville? 22 A. No. 23 Q. Do you drive -- do you not do that just 24 because of your anxiety or -- Page 137 1 A. Yes. 2 Q. There is nothing physically that prevents 3 from you driving? 4 A. Right. I just get too paranoid. 5 Q. Do you recall having a pelvic ultrasound that 6 showed multiple ovarian cysts? 7 A. Yes. 8 Q. Were you having pelvic pain? 9 A. Yes. 10 Q. Mark the next one, and this will be 13. 11 MS. HENSLEY: Let's go off again so you can 12 look at this one. 13 (Exhibit No. 13 was marked for 14 identification.) 15 THE VIDEOGRAPHER: Off the record at 11:41. 16 (There was a brief recess.) 17 THE VIDEOGRAPHER: We are back on the record 18 at 11:43. 19 BY MS. HENSLEY: 20 Q. So the document I just handed you is dated 21 June 18, 2010. 22 Again, it is as another record from 23 Dr. Patterson, correct? 24 A. Yes. Case 2:12-cv-01712 Document 51-1 Filed 07/08/16 Page 12 of 17 PageID #: 318 Carol Ann Suter Golkow Technologies, Inc. - 1.877.370.DEPS 36 (Pages 138 to 141) Page 138 1 Q. And at that point, it looks like that you-all 2 are still discussing treatment options. 3 Does that sound accurate? 4 A. Yes. 5 Q. And you still did not want to go to Lexington 6 for the urodynamics study? 7 A. Right. 8 Q. And you were having occasional urgency and 9 incontinence? 10 A. Yes. 11 Q. And you were going to continue trying to take 12 medication at that time? 13 A. I'm assuming. 14 Q. The next exhibit that I'm going to mark is 15 14. 16 (Exhibit No. 14 was marked for 17 identification.) 18 BY MS. HENSLEY: 19 Q. This is medical record, again, from 20 Dr. Patterson dated August 17, 2010. 21 MS. HENSLEY: Let's go off the record 22 again. 23 THE VIDEOGRAPHER: We'll off the record at 24 11:44. Page 139 1 (There was a brief recess.) 2 THE VIDEOGRAPHER: Back on the record. 3 BY MS. HENSLEY: 4 Q. Have you had a chance to look that over? 5 A. Yes. 6 Q. Yes? 7 And at that point, you were still having 8 frequency of urination, correct? 9 A. Yes. 10 Q. And if you look down to that main paragraph 11 there on first page, it says, you "were interested in 12 having the TVT redone." 13 Do you remember the discussion that you had 14 with Dr. Patterson about that? 15 A. No. 16 Q. Do you remember telling him that you were 17 interested in having the TVT redone? 18 A. What? Another bladder repair? 19 Q. Well, that was my question to you. 20 When it says this in the record, do you 21 recall telling him that you wanted to have the TVT 22 redone? 23 A. No. 24 Q. You don't recall doing that? Page 140 1 A. No. 2 Q. Do you think that's inaccurate in the 3 record? 4 A. I don't remember talking to him about that. 5 Q. Okay. And Dr. Patterson says he's "not sure 6 that this will help." 7 Do you recall having a discussion with him 8 about that? 9 A. Well, then, maybe. Maybe, maybe we did. 10 Q. You just don't recall? 11 A. I just don't recall. 12 Q. And he tried to increase your dosage of 13 medication at that point? 14 A. Okay. 15 Q. Do you recall that? 16 A. No. But I'm -- I guess he did. 17 Q. And did the medication help? 18 A. I have no idea. Well, evidently not. 19 Q. Again, he recommended going to Lexington for 20 further testing? 21 A. Yes. 22 Q. And you didn't want to do that? 23 A. No. 24 Q. Did you ever talk to anybody else about Page 141 1 driving you to Lexington? 2 A. I mean, I don't have anybody to do that for 3 me. 4 Q. Your son couldn't do that for you? 5 A. No. My son didn't live around here then. He 6 lived in Colorado. 7 Q. I want you to look back, if you will, at 8 exhibit -- I think Exhibit 5, which is your Plaintiff 9 Fact Sheet. 10 MS. LARMOND-HARVEY: Fact Sheet is six. 11 Profile was five. 12 MS. HENSLEY: Okay. Thank you. 13 BY MS. HENSLEY: 14 Q. Exhibit 6. 15 We talked earlier about -- if you go to page 16 6 of that document, please. 17 We talked earlier about after the mesh 18 surgery when you began experiencing symptoms, that you 19 had symptoms of pain, pain with sex, you started 20 having incontinence problems and so forth. 21 So I want you to look at Question 6 on page 22 6. And it asks about the bodily injuries that you 23 experienced as a result of the Ethicon mesh product. 24 So, A, it says, "Describe the bodily Case 2:12-cv-01712 Document 51-1 Filed 07/08/16 Page 13 of 17 PageID #: 319 Carol Ann Suter Golkow Technologies, Inc. - 1.877.370.DEPS 37 (Pages 142 to 145) Page 142 1 injuries, including any emotional or psychological 2 injuries that you claim resulted from the implantation 3 of the mesh product." 4 And the responses is, "Constant vaginal pain 5 and bleeding, recurrence of bladder incontinence, 6 painful sex, deterioration of marriage and 7 depression." 8 Is that true? 9 A. Yes. 10 Q. Are those accurate responses? 11 A. Yes. 12 Q. And then the next section it says, "When is 13 the first time you began experiencing symptoms of any 14 of the bodily injuries you claim in your lawsuit to 15 have resulted from the pelvic mesh product? " 16 And your response is, "I began to experience 17 symptoms about three months after implantation." 18 Is that true? 19 A. The -- the pressure of the bladder and the 20 leaking, yes. 21 Q. And the pain with sex, as well? 22 A. Yes. Very first time after, yes. 23 Q. Okay. And C, "When you did you first 24 attribute these body injuries to the pelvic mesh Page 143 1 product? " 2 Your response is, "At the onset of the 3 symptoms." 4 Is that true? 5 A. I don't understand that question. 6 Q. When did you first believe that the injuries 7 that you were experiencing were related to the pelvic 8 mesh products? 9 A. Right after I had it done pretty much. 10 Because, I mean, the symptoms didn't change. The 11 symptoms -- I still had it. 12 Q. And you knew at that point that they were 13 related to the mesh product? 14 A. Yes. Well, actually I wasn't sure. I just 15 assumed they were. 16 Q. But you believe that they were at that point 17 in time? 18 A. I'm not sure. 19 Q. The response to number C, or, I'm sorry, to 20 letter C under number 5 says, "When did you first 21 attribute these bodily injuries to the pelvic mesh 22 products?" and your response was, "At the onset of the 23 symptoms." 24 A. I know, but I don't know what that means is Page 144 1 what I'm trying to tell you. 2 Q. Do you believe that this is inaccurate? 3 A. Oh, my God. I don't know. No. I don't. 4 No. 5 Q. So you believe that this is correct, your 6 response -- 7 A. Yes. 8 Q. -- in this document? 9 Okay. After the mesh surgery and at the 10 point in time in 2010 when you were treating with 11 Dr. Patterson, how often were you experiencing 12 incontinence? 13 A. When? 14 Q. In the 2010 time frame when you were treating 15 with Dr. Patterson. 16 A. I don't know what you mean. 17 Q. In 2010, after the mesh surgery, how often 18 were you experiencing urinary leakage? 19 A. All the time. 20 Q. Every day? 21 A. Pretty much. 22 Q. How severe was it? How much urine were you 23 losing? 24 A. I don't know. Page 145 1 Q. Was it leaking out on your clothing? 2 A. I had to wear, like, pads. 3 Q. How many pads would you have to wear in the 4 day? 5 A. Probably four or five. 6 Q. And were they -- can you describe the pads 7 that you were wearing? Were they heavy? 8 A. Heavy pads. 9 Q. I'm sorry. Excuse me. 10 A. And I still have to wear them. 11 Q. At that point in time, again 2010, were you 12 experiencing again the sudden urge to urinate? 13 A. Yes. 14 Q. Were you experiencing leakage with physical 15 activity? 16 A. Yes. 17 Q. Were you experiencing leakage just when you 18 would be standing up? 19 A. Yes. 20 Q. Could you have -- did have you any sensation 21 about having to go before the urinary leakage would 22 occur? 23 A. No. 24 Q. Were there any other activities that caused Case 2:12-cv-01712 Document 51-1 Filed 07/08/16 Page 14 of 17 PageID #: 320 Carol Ann Suter Golkow Technologies, Inc. - 1.877.370.DEPS 45 (Pages 174 to 177) Page 174 1 mesh removed? 2 A. That he can go in there and that it needed to 3 be removed. 4 Q. Why did he say it needed to be removed? 5 A. I'm assuming because it caused tissue 6 damage. 7 Q. I'm asking what he actually relayed to you. 8 A. Well, I don't exactly remember everything, 9 how he said it is what I'm saying, but that's what we 10 were talking about. 11 Q. That's what I wanted to understand. 12 A. Yeah. 13 Q. The reasons he gave you for needing to have 14 the mesh removed. 15 A. Tissue damage. 16 Q. Did he tell you that all these symptoms that 17 you were experiencing were related to the mesh? 18 Did he tell you that the pelvic pain was 19 related to the mesh? 20 A. Yes. 21 Q. Did he tell you that the pain with sex was 22 related to the mesh? 23 A. Yes. 24 Q. Did he tell you that the urinary incontinence Page 175 1 was related to the mesh? 2 A. No. Not -- no. 3 Q. Did he tell you bleeding was related to the 4 mesh? 5 A. Yes. 6 Q. After the -- well, first of all, did 7 Dr. Azadi tell you how the surgery went? 8 A. I don't remember. 9 Q. Did he tell you that the surgery went well, 10 after the surgery? 11 A. I'm sure he did, but I was just out of it. I 12 don't remember. 13 Q. Do you remember if he told you there were any 14 complications during your surgery? 15 A. I don't know. 16 Q. Do you remember having any complications 17 after the surgery? 18 A. No. 19 Q. No infections? 20 A. No. 21 Q. After the revision surgery in May, 2014, did 22 your symptoms change? 23 A. What do you mean? The bleeding stopped. 24 Q. Okay. Anything else? Page 176 1 A. And the -- the abdominal pressure and pain 2 inside and just at my underwear line, that eased up. 3 But as far as the sex, I mean, we have tried 4 again, tried, and it is still the same. 5 Q. So no change with the pain with sex? 6 A. Right. 7 Q. What about urinary incontinence? Did those 8 symptoms change? 9 A. No. 10 Q. Did they become worse? 11 A. Yes. 12 Q. How much worse? 13 A. It is -- it is back -- it is probably worse 14 than it was before I even had the surgery. 15 Q. So what do you mean when you say that? 16 A. Before when, like I said, stand up and -- but 17 it is worse, more comes out now. The coughing, the 18 sneezing, that is worse. 19 I mean, I could -- I don't even feel like I 20 have to go and when I stand up, it's like I just feel 21 it come out. And I don't even realize that I even 22 have to go. 23 And then, like, sometimes when I am in there 24 going, it is like it will -- it will go and then it Page 177 1 will stop and I think I'm done. I get ready to get 2 up, and there it comes again. It is like, uhmm. 3 Q. Do you have sensation of having to go 4 urinate? 5 A. No. I mean -- I mean, I can tell, like -- 6 but then there's sometimes I can't. It is like it 7 just sits there and I don't even realize it's -- and 8 it just comes out. 9 Q. But sometimes you do feel like you have the 10 urge to urinate? 11 A. Yes. 12 Q. And then you go to the bathroom -- 13 A. Yes. 14 Q. -- and you don't have an accident? 15 A. Right. 16 Q. That's not always the case? 17 A. Right. 18 Q. Can you give me a -- well, how many times a 19 day do you have accidents? 20 A. Well, I mean, like I said, I wear pads every 21 day, so... 22 Q. And then you had another surgery in October 23 of 2014 for the stress urinary incontinence, true? 24 A. Yes. Case 2:12-cv-01712 Document 51-1 Filed 07/08/16 Page 15 of 17 PageID #: 321 Carol Ann Suter Golkow Technologies, Inc. - 1.877.370.DEPS 46 (Pages 178 to 181) Page 178 1 Q. Who performed that surgery? 2 A. Dr. Azadi. 3 Q. And was that a Burch procedure? 4 A. Yes. 5 Q. Is that the way he described it to you? 6 A. Yes. 7 Q. Did he tell you what that meant? 8 A. He told me he was going to take and -- take 9 a -- I think he said a tendon of my own and just kind 10 of arch it up, raise my bladder back up and tack it up 11 like that. 12 That's pretty much how much I understood 13 it. 14 Q. Did you tell him -- did you-all have a 15 discussion about using mesh again at that point? 16 A. No. 17 Q. Did you tell him that you did not want to use 18 mesh again? 19 A. Yes. 20 Q. What were the results of that surgery? 21 A. I mean, like I said, it's -- I'm back -- I'm 22 still have the -- the wetting. I mean, it is there. 23 It is worse now than it was before I even had the 24 surgery to begin with. Page 179 1 Q. Before 2008? 2 A. Yes. 3 Q. Did the Burch surgery help at all? 4 A. No. 5 Q. Was there any period of time when it helped 6 after the surgery? 7 A. Not that I could tell. 8 Q. Has any other medical professional made any 9 comments to you about the mesh product? 10 A. No. 11 Q. Do you still experience pain with sex? 12 A. Yes. 13 Q. Every time that you attempt sex? 14 A. Yes. 15 Q. What is the last time that you attempted to 16 have sex? 17 A. Oh, good Lord. I would say at least a 18 month. 19 Q. Was it painful at that point? 20 A. Yes. 21 Q. Were you able to complete sexual intercourse 22 or did you have to stop? 23 A. We finished. 24 Q. Can you rate your pain on scale of one to Page 180 1 ten? 2 A. That I have during sex? 3 Q. Yes, ma'am. 4 A. Probably about a seven. 5 Q. Is it like that every time? 6 A. Yes. And it has been worse. I mean, it has 7 been so bad it just -- I mean, it just -- I just break 8 down crying. And it's like I just can't do it. I 9 just can't do it. And that's good. That's okay. 10 Q. So, how often in the last -- in the last two 11 years have you attempted to have sex? 12 A. I don't know. That's a tough one. Like I 13 said, we don't even live together, so... 14 Q. Less than once a month? 15 A. Oh, no. No. It is, like, maybe every three 16 months. 17 Q. Has any medical professional ever told you 18 that there was problem with the way that the mesh was 19 implanted? 20 A. No. 21 Q. Do you still -- do you have vaginal pain? 22 A. Yes. 23 Q. How often? 24 A. Just, I mean, it just comes and goes. Page 181 1 Q. Every day? 2 A. Pretty much. 3 Q. When did that begin? 4 A. It is just, like, really weird. Just, I 5 don't know. It just -- it just happens. 6 Q. When did that start? 7 A. I don't even remember. 8 Q. Since the mesh removal -- 9 A. Yes. 10 Q. -- or before? 11 A. Before. 12 Q. Did you have it before then? 13 A. Before. 14 Q. Did you have it before 2008? 15 A. No. 16 Everything was fine till I had that 17 surgery. 18 Q. And then you still -- you still continue to 19 have pelvic pain, correct? 20 A. Yeah. I mean, it is not nothing like it was, 21 but it is -- I still have it sometimes, yes. 22 Q. When you say "nothing like it was," do you 23 mean before -- 24 A. Before they took care of the cysts and the -- Case 2:12-cv-01712 Document 51-1 Filed 07/08/16 Page 16 of 17 PageID #: 322 Carol Ann Suter Golkow Technologies, Inc. - 1.877.370.DEPS 52 (Page 202) 1 STATE OF KENTUCKY ) ) SS 2 COUNTY OF JEFFERSON ) 3 I, Kimberley Ann Keene, a notary public, within 4 and for the State at Large, do hereby certify that the 5 foregoing deposition of 6 Carol Ann Suter 7 was taken before me at the time and place and for the 8 purpose in the caption stated; that the witness was 9 first duly sworn to tell the truth, the whole truth 10 and nothing but the truth; that the deposition was 11 taken before me stenographically and transcribed by 12 me; that the foregoing is a full, true and complete 13 transcript of the said deposition so given; that there 14 was no request that the witness read and sign the 15 transcript; that the appearances were as stated in the 16 caption. 17 I further certify that I am neither counsel or of 18 kin to any of the parties to this action, and am in no 19 way interested in the outcome of said action. 20 Witness my signature this 5th day of April, 21 2016. My Commission Expires on September 27, 2016. 22 23 _______________________________ Kimberley Ann Keene 24 Registered Professional Reporter Case 2:12-cv-01712 Document 51-1 Filed 07/08/16 Page 17 of 17 PageID #: 323 EXHIBIT B Case 2:12-cv-01712 Document 51-2 Filed 07/08/16 Page 1 of 17 PageID #: 324 John Patterson, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS Page 1 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF WEST VIRGINIA AT CHARLESTON IN RE: ETHICON, INC., Master File No. 2:12-MD-02327 PELVIC REPAIR SYSTEM MDL 2327 PRODUCTS LIABILITY LITIGATION JOSEPH R. GOODWIN U.S. DISTRICT JUDGE __________________________________________________ CAROL & TROY SUTER, Plaintiffs, Case No. 2:12-cv-01712 v. ETHICON, INC. ET AL., Defendants. ____________________________________________________ WITNESS: JOHN PATTERSON, M.D. ____________________________________________________ The video deposition of John Patterson, M.D. was taken before Janine N. Leroux, Stenographic Court Reporter and Notary Public - in and for the State of Kentucky at Large, at the Law Offices of Sturgill Turner Barker & Moloney, 333 West Main Street, Lexington, Kentucky on Wednesday, April 13, 2016, commencing at the approximate hour of 9:11 a.m. Said deposition was taken pursuant to Notice. GOLKOW TECHNOLOGIES, INC. 877.370.3377 ph | 917.591.5672 fax deps@golkow.com Case 2:12-cv-01712 Document 51-2 Filed 07/08/16 Page 2 of 17 PageID #: 325 John Patterson, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 4 (Pages 10 to 13) Page 10 1 A Yes. 2 Q You are a member of the American 3 Urological Association? 4 A I am. 5 Q You are member of the American 6 Association of Clinical Urologists? 7 A I am. 8 Q Any other professional societies? 9 A I think that that -- that's it, yes. 10 Q All right. What is stress urinary 11 incontinence? 12 A Stress incontinence is incontinence 13 that occurs when a patient increases abdominal 14 pressure either through a cough, sneeze, Valsalva 15 and it leaks, as a result leaks. 16 Q And then it leaks as a result? 17 A Uh-huh (affirmative). 18 Q Okay. When did you first learn about 19 stress urinary incontinence which we may refer to 20 as SUI? 21 A Well, that's part of our residency 22 training. 23 Q So that would be in the 1984 to '88 24 time period? 25 A Yes. Page 11 1 Q How long have you treated patients for 2 stress urinary incontinence? 3 A Since -- since the inception of my 4 residency. 5 Q Since 1984? 6 A Yes. 7 Q Do you have any idea how many patients 8 you've treated for SUI? 9 A Hundreds. 10 Q What percentage of your practice 11 involves the treatment of SUI? 12 A Probably about 10 percent. 13 Q Can you estimate the number of patients 14 you have surgically treated for SUI before you 15 implanted the TVT in Mrs. Suter which was March of 16 2008? 17 A Probably I would say at least 100. 18 Q Can you estimate the total number of 19 SUI surgeries you've done throughout your career 20 and I'm including mesh and non-mesh. 21 A Over 100. 22 Q Over 100? 23 A Uh-huh (affirmative). 24 Q Were you trained on any type of 25 non-mesh surgery to treat SUI? Page 12 1 A Yes. 2 Q What procedures were those? 3 A Primarily the Burch colposuspension. 4 The -- you know, all of these things were kind of 5 a timeframe. Each one would have an advantage 6 over the other, and so we would do the Stamey 7 needle suspension procedures, the rods, four 8 corner suspension procedures. 9 Q And when you say over a timeframe, you 10 mean you would do certain procedures and then 11 medical science would develop and you would then 12 -- 13 A That's correct. 14 Q -- do other procedures? 15 A Yes. 16 Q Do you have any idea how many times 17 you've performed the Burch procedure? 18 A Probably 50. 19 Q Do you perform the Burch so much 20 anymore? 21 A No. 22 Q Why is that? 23 A Because it involves a significant 24 incision, a significant postoperative recovery 25 period. I just think that there are other Page 13 1 procedures that are better. 2 Q Including mesh? 3 A Including mesh. 4 Q How often have you performed the Stamey 5 needle procedure? 6 A I'd say at least 50 primarily during 7 residency. 8 Q When did you first use mesh to treat 9 SUI? 10 A I can't remember the date but shortly 11 after it was introduced. 12 Q Is it fair to say that in the mid or 13 late '90s mid urethral slings made with 14 polypropylene mesh became available to treat 15 patients -- 16 A Yes. 17 Q -- with SUI? 18 Do you think you were using the slings 19 then since the mid or late '90s? 20 A Yes. 21 Q Did mid-urethral slings develop because 22 of dissatisfaction by surgeons in the safety and 23 effectiveness of the native tissue repairs for 24 SUI? 25 A Yes. Case 2:12-cv-01712 Document 51-2 Filed 07/08/16 Page 3 of 17 PageID #: 326 John Patterson, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 5 (Pages 14 to 17) Page 14 1 Q Yes? 2 A Yes. 3 MS. WURDOCK: Let her finish her 4 question. 5 Q How did you learn how to treat SUI with 6 mesh? 7 A Well, these are -- you know, it's not a 8 new procedure. It's just an improvement on the 9 old procedures, so it's really not a new 10 procedure. 11 Q Did you go through any professional 12 training, training programs or watch videos? 13 A Well, I'm sure that there were videos. 14 I'm sure that there was -- I did go to a training 15 program, or at least a meeting on implantation of 16 mesh. 17 As I remember it was with Dr. Klutke in 18 St. Louis. I don't remember any of the details of 19 that it's been so long ago. 20 Q When did you start using TVT? 21 A Probably -- that was the first mesh 22 product that we used. 23 Q So it's been a while? 24 A Yes. 25 Q How many TVT procedures have you done Page 15 1 in total, and I'm including the entire TVT family 2 of devices. 3 A Again, over 100 probably. 4 Q Do you know how many TVT procedures you 5 had performed before the March 2008 implant 6 involving the Plaintiff here? 7 A No, I can't tell you how many. 8 Q Was it several, was it one? 9 A Oh, yeah. 10 Q Many? 11 A Many. 12 Q Do you know how many SUI mesh 13 procedures using non-Ethicon products you may have 14 performed before March of 2008? 15 A Little or none. 16 Q So you mainly used the Ethicon family 17 of products? 18 A Yes, yes. 19 Q Do you currently use TVT products? 20 A Yes. 21 Q Do you use mesh products from any other 22 manufacturer today? 23 A No. 24 Q What has your experience been with TVT 25 mesh? Page 16 1 A Excellent results. 2 Q Do you -- did you attend or teach any 3 Ethicon professional education events? 4 A No. I may have attended but not -- 5 Q Not talked? 6 A -- not talked. 7 Q Do you recall any specifically that you 8 attended? 9 A I do know that I attended an Ethicon 10 meeting at their headquarters in Cincinnati, but I 11 can't remember if it was regarding a mesh product 12 or they -- they have a lot of different things 13 that they were doing at that time. 14 (Defendants' Exhibit 3 was marked.) 15 Q Let me hand you what I've marked as 16 Exhibit 3, and this is a Surgeon's Resource 17 Monograph from Gynecare. Do you recall receiving 18 from Ethicon this Surgeon's Resource Monograph? 19 A No. 20 Q Is it possible you reviewed the 21 document before you performed surgery on the 22 Plaintiff, but you don't recall as we sit here 23 today? 24 A I -- I don't recall. 25 Q You don't recall one way or the other? Page 17 1 A I don't recall this document. 2 (Defendants' Exhibit 4 was marked.) 3 Q All right. Let me hand you what I'm 4 marking then as Exhibit 4, and these are your 5 medical records. You can put Exhibit 3 aside. 6 And these are a collection of the 7 records we received from you regarding your care 8 and treatment of the Plaintiff. 9 MS. POPE: Joe, would you stipulate to 10 their authenticity? 11 MR. SAUNDERS: Yes. 12 MS. POPE: Thank you. 13 BY MS. POPE: 14 Q These documents have Bates numbers, but 15 I went ahead and added Nos. 1 through 30 with my 16 felt tip marker then. So to help us get through 17 the records, I'll refer to those page numbers. 18 A Okay. 19 Q Now, Doctor, as an initial matter, do 20 you remember Mrs. Suter? I know it's been a while 21 since you treated her? 22 A No. 23 Q No independent recollection? 24 A No. 25 Q Did you review her medical records to Case 2:12-cv-01712 Document 51-2 Filed 07/08/16 Page 4 of 17 PageID #: 327 John Patterson, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 8 (Pages 26 to 29) Page 26 1 Q And you found a Grade 2? 2 A A Grade 2, which it is a droppage but 3 not beyond the opening. 4 Q Can a Grade 2 cystocele have an impact 5 on the stress urinary incontinence she was 6 reporting? 7 A Yes. 8 Q How so? 9 A Well, with the -- she also had 2 10 centimeters of urethral movement, which, at least 11 in theory, pulls open the sphincter and allows the 12 incontinence to occur. 13 Q I see. So ultimately did you recommend 14 to her the TVT mesh? 15 A Yes. 16 Q Was TVT in your opinion a reasonable 17 and appropriate option for Mrs. Suter? 18 A Yes. 19 Q Let me ask you then some questions 20 about the implant, itself. I know that was on 21 March 5, 2008. 22 A Uh-huh (affirmative). 23 Q Do you believe you had a robust 24 informed consent process? 25 A At the time, yes. Page 27 1 Q At the time? 2 A Well, given the current medical/legal 3 climate. 4 Q That's effected what you tell patients, 5 hasn't it? 6 A It has, definitely. 7 Q Do you recall what you would have told 8 Mrs. Suter back in 2008 about the risks of TVT? 9 A Yes. We talk about -- and this is just 10 in general. I don't remember exactly what I told 11 her but -- 12 Q But what your pattern and practice -- 13 A And what I would in general discuss 14 with the patients is that we would expect the 15 usual bleeding, infection, risks of anesthesia 16 with any kind of surgical procedure. 17 Specifically with this type of 18 procedure, there is an increased risk of hematoma, 19 injury to bowel and bladder. Injury to the 20 urethra. We would also talk about a risk, but a 21 low risk, of erosion and mesh exposure. 22 Q Did you give Mrs. Suter any documents 23 or would you have given patients in 2008 any 24 documents to warn them about the risks of TVT? 25 A Well, I give them a -- Ethicon does Page 28 1 provide a document for stress incontinence, and 2 that's what we would provide for the patient. 3 Q Okay. And is that the brochure that 4 your counsel brought today? 5 A Brochure, yes. 6 MS. POPE: And we'll go ahead and mark 7 that as exhibit I think 11. There's a reason 8 I'm going out of order. 9 (Defendants' Exhibit 11 was marked.) 10 BY MS. POPE: 11 Q Did Mrs. Suter sign a consent form? 12 A Yes. 13 Q And on Page 4 of the documents that you 14 have there in front of you, is that the consent? 15 A Yes. 16 Q Is that your signature on the consent? 17 A Yes. 18 Q And you affirmed that consistent with 19 your best medical judgement, you had fully 20 explained the nature, purpose, alternative risks 21 and potential complications of the treatments 22 and/or procedures? 23 A Yes. 24 Q All right. If you look at Page 7 and 25 8, that's the operative report. And that's again Page 29 1 dated 3/5/2008 and Bates No. 270 through 71. 2 Page 2 notes there was a tension-free 3 placement of the sling. What does that mean? 4 A Well, in a lot of the older procedures 5 with the Stamey and rods procedures where you're 6 trying to -- you basically are trying to lift the 7 paravaginal tissue pretty tightly around the 8 urethra. 9 With the TVT sling procedures, you want 10 it to be tension-free, no -- no significant 11 tension against the urethra. So basically in 12 order to do that, I would place a curved Mayo 13 between the urethra and the sling, pull it up 14 snug, but then you'd have that space available. 15 Q So you implanted it according to your 16 clinical experience and training? 17 A Yes, yes. 18 Q In your operative report I don't see 19 any note of any complications. 20 A Yes. 21 Q If you had any would you have noted 22 them? 23 A Yes. 24 Q All right. It looks like in March then 25 she followed up with you on two occasions and Case 2:12-cv-01712 Document 51-2 Filed 07/08/16 Page 5 of 17 PageID #: 328 John Patterson, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 9 (Pages 30 to 33) Page 30 1 those are Pages 9 and 10. 2 Was she having any problems with 3 leaking with cough or sneeze? 4 A It appears, no, on March the 10th. 5 Q Okay. And did it seem to you that the 6 TVT was doing its job? 7 A Yes. 8 Q It alleviated her stress urinary 9 incontinence? 10 A Yes. 11 Q What were her complaints on these 12 visits in March on the 10th and the 31st? 13 A Let's see, she had some vaginal 14 bleeding. 15 Q Okay. 16 A Which is normal immediately postop. 17 This was -- this was the one week follow-up. 18 Q Okay. 19 A And then a month later, or 20 approximately a month later, some urinary 21 frequency and urgency. 22 Q Okay. And are those conditions that 23 TVT addresses? 24 A No. 25 Q Now, I'm referring you to Page 11. It Page 31 1 looks like after 2008 you had not seen her then 2 until 2010; is that correct? 3 A That's correct. 4 Q And it's a May 20, 2010 visit, Bates 5 No. COMUR83. Had you heard from Mrs. Suter as far 6 as you know during that two year gap? 7 A No. 8 Q On May 2010 what was her chief 9 complaint? 10 A She was having more frequency and 11 urgency. 12 Q Did she complain to you of any stress 13 urinary incontinence? 14 A No. 15 Q Did you do a pelvic exam? 16 A Yes. 17 Q What did that reveal? 18 A That she had a slight cystocele but no 19 significant urethral mobility, slight tenderness. 20 Q Did you note anywhere in your record 21 any mesh erosion? 22 A No. Well, I did look for that and 23 could not feel any -- any defect. 24 Q Okay. And you prescribed her 25 medication? Page 32 1 A I did. 2 Q Toviaz? 3 A Toviaz. 4 Q What was that for? 5 A That's for the urgency and overactivity 6 of the bladder. 7 Q Did you suggest that she may have her 8 TVT redone? 9 A Well, I think that -- well, we talked 10 about that possibility, yes. 11 Q All right. Did you then see Mrs. Suter 12 again in June? And these are records 17 through 13 20 and 22 through 25. 14 A Yes, I did see her again in June. 15 Q All right. And was she still 16 experiencing frequency? 17 A Frequency, yes. 18 Q Did you recommend any testing that she 19 undergo? 20 A We suggested urodynamics. 21 Q Did that occur? 22 A No. 23 Q Why was that? 24 A The urodynamics that I preferred to do 25 were called video urodynamics, and it was Page 33 1 available in Lexington not in Shelbyville or 2 Frankfort where we were practicing. 3 Q So did you perform in-office testing? 4 A We did with just cystoscopy to look 5 inside the bladder and urethra and also bladder 6 filling, which basically we call eyeball 7 urodynamics. 8 Q Did you on the cystoscopy see any 9 erosion? 10 A No. 11 Q Did you see any bladder leakage? 12 A No. 13 Q Did you see any stress urinary 14 incontinence? 15 A No. 16 Q And then it looks like she returned to 17 your practice in August and this is Pages 26 18 through 29. Was she experiencing any stress 19 urinary incontinence? 20 A She said that she did, but I could not 21 demonstrate it. 22 Q All right. Did you recommend 23 InterStim®? 24 A Well, I suggested that that was a 25 possibility. Case 2:12-cv-01712 Document 51-2 Filed 07/08/16 Page 6 of 17 PageID #: 329 John Patterson, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 10 (Pages 34 to 37) Page 34 1 Q What is that? 2 A It's neuromodulation of the nerves that 3 come from the spine. 4 Q Is that for overactive bladder? 5 A For overactive bladder primarily, yes. 6 Q Did you also increase her overactive 7 bladder medication? 8 A I did. 9 Q You indicated she was interested in 10 having the TVT redone. You were not sure this 11 would help. Why was that? 12 A Well, I couldn't demonstrate any 13 leaking in both the supine and standing positions. 14 I felt that her problem was urgency and 15 overactivity and not stress. 16 Q Stress, thank you. 17 And my records show that she was a 18 no-show for the September 2010 -- 19 A Yes. 20 Q -- appointment. And do you have any 21 indication that you've seen her since? 22 A I have not. 23 Q All right. I'm done with that exhibit. 24 Doctor, do you agree that dyspareunia 25 and pelvic pain can be caused by a number of Page 35 1 different factors? 2 A Yes. 3 Q Would those include menopause, vaginal 4 atrophy? 5 A Yes. 6 Q Previous pelvic surgery? 7 A Yes. 8 Q Weak connective tissue? 9 A Yes. 10 Q Adhesions? 11 A Yes. 12 Q Did Mrs. Suter tell you she had been 13 diagnosed with fibromyalgia? 14 A I don't remember that specifically. 15 Q Do you treat patients with 16 fibromyalgia? 17 A No, not directly. 18 Q Okay. Is that a chronic pain syndrome? 19 A It's -- it is a syndrome that involves 20 pain. And I'm not sure -- I think there's some 21 debate about whether that's real or not -- 22 Q Oh, I see. 23 A -- fibromyalgia. 24 Q Did Mrs. Suter tell you she had a 25 history of chronic back pain? Page 36 1 A Yes. 2 Q Can chronic back pain cause 3 dyspareunia? 4 A It could. 5 Q Can it radiate into the pelvis? 6 A It could. 7 Q Do you know what interstitial cystitis 8 is? 9 A Yes. 10 Q What it is? 11 A Well, it is somewhat of a diagnosis of 12 exclusion. It is a chronic irritation of the 13 bladder that does not appear to be due to 14 bacterial infections or demonstrable infection. 15 Q Can frequency of urination be a symptom 16 of interstitial cystitis? 17 A Yes. 18 Q Urgency? 19 A Yes. 20 Q Can a woman with interstitial cystitis 21 experience pain with intercourse? 22 A Yes. 23 Q Or pelvic pain? 24 A Yes. 25 Q Doctor, in an effort to provide Page 37 1 medical -- quality medical care to your patients, 2 is it fair to say that you familiarize yourself 3 with the safety information before using a mesh 4 for the first time? 5 A Yes. 6 Q And is one of the ways you educate 7 yourself about surgeries you perform and the 8 medical devices you implant is by reading medical 9 journals? 10 A Yes. 11 Q And attending medical conferences? 12 A Yes. 13 Q Talking to your colleagues in medicine? 14 A Yes. 15 Q And also do you base your prescription 16 decisions on your clinical expertise? 17 A Yes. 18 Q Do you agree or disagree that no 19 surgery is a hundred percent risk-free? 20 A Agree. 21 Q Do you agree or disagree that all 22 pelvic floor surgeries have basic known risks? 23 A Agree. 24 Q As a surgeon do you ever guarantee any 25 outcomes to patients? Case 2:12-cv-01712 Document 51-2 Filed 07/08/16 Page 7 of 17 PageID #: 330 John Patterson, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 11 (Pages 38 to 41) Page 38 1 A No. 2 Q Every time you do surgery on a patient 3 in their pelvis, are there certain risks 4 associated with that surgery? 5 A Yes. 6 Q Does a bad outcome mean that there's 7 something wrong with the surgery? 8 A No. 9 Q Does a bad outcome mean that there's 10 something wrong with the product? 11 A No. 12 Q With regard to the TVT, the fact that 13 erosion, pelvic pain or dyspareunia may occur, 14 does not mean the mesh is defective, does it? 15 A No. 16 Q If a patient develops a side effect, 17 does that mean you were incorrect in deciding to 18 prescribe surgery with mesh? 19 A No, I think there are -- there are 20 risks to the procedure as -- 21 Q Sometimes do side effects happen? 22 A Yes. 23 Q Do you weigh the benefits of the 24 surgical mesh versus the potential risks and side 25 effects in relation to a particular patient's Page 39 1 needs and circumstances? 2 A Yes. 3 Q Is that what you did for Mrs. Suter? 4 A I believe so. 5 Q Is one of the sources of information 6 that you rely on in your practice of medicine 7 various position statements by the physician 8 groups in your field of expertise? 9 A Yes. 10 Q We talked about that you're a member of 11 the American Urological Association, and I'm going 12 to read you one of the their statements and you 13 tell me if you agree or disagree with it. 14 "Suburethral synthetic polypropylene 15 mesh sling placement is the most common surgery 16 currently performed for SUI. Extensive data 17 exists to support the use of synthetic 18 polypropylene mesh suburethral slings for the 19 treatment of female SUI with minimal morbidity 20 compared with alternative surgeries." 21 Do you agree with that statement of 22 November 2011 from the AUA? 23 A I agree. 24 Q Do you agree or disagree with this 25 statement from the AUA. "Advantages include Page 40 1 shorter operative time, anesthetic need, reduced 2 surgical pain, reduced hospitalization and reduced 3 voiding dysfunction. Mesh-related complications 4 can occur following polypropylene sling placement, 5 but the rate of these complications is acceptably 6 low. 7 Furthermore, it is important to 8 recognize that many sling-related complications 9 are not unique to mesh surgeries and are known to 10 occur with non-mesh sling operations as well." 11 A I would agree. 12 Q Do you agree or disagree with this 13 statement? "It is the AUA's opinion that any 14 restriction on the use of a synthetic 15 polypropylene mesh suburethral sling would be a 16 disservice to women who choose surgical correction 17 of SUI." 18 A I do. 19 Q Do you agree or disagree with this last 20 statement? And this is from AUGS, the American 21 Urogynecological Society and SUFU. "The 22 polypropylene mesh mid-urethral sling is the 23 recognized worldwide standard of care for the 24 surgical treatment of stress urinary incontinence. 25 The procedure is safe, effective and has improved Page 41 1 the quality of life for millions of women." 2 A I would agree with that. 3 Q Doctor, is TVT an important treatment 4 option that needs to be available to women and to 5 surgeons? 6 A I think so. 7 Q Is TVT one of the best studied 8 procedures for the treatment of stress urinary 9 incontinence? 10 A It certainly has been studied 11 extensively. 12 Q What are the benefits, if any, of the 13 TVT that you have seen in your practice? 14 A I just think it's a substantial 15 advantage over what was available before. 16 Q The native tissue repair? 17 A Certainly, yes, because of significant 18 morbidity in harvesting the fascia. You just -- 19 Q So TVT is a less invasive surgical 20 option -- 21 A Yes. 22 Q -- than Burch or the fascial sling you 23 were describing? 24 A The Burch and the MMK-type 25 procedures -- you know, in residency we would take Case 2:12-cv-01712 Document 51-2 Filed 07/08/16 Page 8 of 17 PageID #: 331 John Patterson, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 12 (Pages 42 to 45) Page 42 1 down as many as we would put in. You know, so I 2 mean those -- those procedures have complications 3 as well. 4 Q And extensive failure rates? 5 A I think if you look at the data as far 6 as improving stress incontinence, they may be 7 fairly similar for the Burch and the TVT, but you 8 got the advantage of less morbidity afterwards. 9 Q Is TVT a less invasive surgical 10 procedure? 11 A Much much less invasive. 12 Q Doctor, in your hands have your 13 patients had a good clinical experience when 14 you've prescribed the TVT? 15 A Yes. 16 Q In your hands have you found that the 17 benefits of the TVT for your patients have 18 outweighed the potential risks? 19 A Yes. 20 Q In your experience have you found that 21 TVT has been a safe and effective treatment option 22 for your patients? 23 A Yes. 24 Q And was that true in 2008 as well? 25 A Yes. Page 43 1 Q Do you generally provide patient 2 brochures to patients? 3 A Yes. 4 Q I know you brought one today. 5 A Yes. 6 Q Do you have an independent recollection 7 of giving a patient brochure to Mrs. Suter? 8 A In 2008 I can't remember, but I'm sure 9 that we did. 10 Q How do you use patient brochures in 11 your counseling of TVT patients? 12 A Well, I give them a number of options 13 when they come in with a particular complaint such 14 as stress urinary incontinence. You know, one 15 would be that we would talk about a surgical 16 option, a medical non-surgical option. 17 You know, there's also treatment with 18 bulking agents and that kind of thing that's 19 become more important I think maybe after her 20 procedure, but currently we talk about all of 21 those things. 22 Q And that was your practice in 2008? 23 A Yes. 24 (Defendants' Exhibit 5 was marked.) 25 Q I'm going to hand you what I've marked Page 44 1 as Exhibit 5, and this is a brochure bearing Bates 2 No. 3279, and I'm going to ask you to turn to Page 3 13. The numbers are in the bottom left in tiny 4 little print. 5 This is a brochure, Stop Coping, Start 6 Living a Gynecare brochure, Treatment Options for 7 Stress Urinary Incontinence. Are you on the page 8 that describes what the risks are? 9 A Yes. 10 Q And I'm going to read this paragraph. 11 "All surgical procedures present some risks. 12 Complications associated with the procedure 13 include injury to blood vessels of the pelvis, 14 difficulty urinating, pain, scarring, pain with 15 intercourse, bladder and bowel injury. 16 There's also a risk of the mesh 17 material becoming exposed. Exposure may require 18 treatment. For a complete description of risks, 19 see the attached product information. 20 Synthetic mesh is a permanent medical 21 device implant. Therefore you should carefully 22 discuss the decision to have surgery with your 23 doctor and understand the benefits and risks of 24 mesh implant surgery before deciding how to treat 25 your condition." Page 45 1 Have you ever read the Ethicon patient 2 brochure before or after implanting the TVT in the 3 Plaintiff? 4 A Yes. I mean, yes, when we got the 5 brochure, I would read it, yes. 6 Q Doctor, were you aware of the risks of 7 injury to the blood vessels of the pelvis before 8 implanting the TVT into Mrs. Suter? 9 A Yes. 10 Q Were you aware of the risk of 11 difficulty urinating before implanting the TVT 12 into Mrs. Suter? 13 A Yes. 14 Q Were you aware of the risk of pain 15 before you did the implant in 2008? 16 A Yes. 17 Q Were you aware of the risk of scarring 18 before you did the implant in 2008? 19 A Yes. 20 Q Were you aware of the risk of pain with 21 intercourse before you implanted the TVT in 22 Mrs. Suter? 23 A Yes. 24 Q How about bladder injury? Were you 25 aware of that before the implant? Case 2:12-cv-01712 Document 51-2 Filed 07/08/16 Page 9 of 17 PageID #: 332 John Patterson, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 13 (Pages 46 to 49) Page 46 1 A Yes. 2 Q Bowel injury? 3 A Yes. 4 Q Were you aware of the risk that mesh 5 could become exposed or eroded before the implant? 6 A Yes. 7 (Defendants' Exhibit 6 was marked.) 8 Q I'm going to hand you Exhibit 6, but 9 could you tell me what medical journals you had 10 read prior to Mrs. Suter's implant surgery if you 11 recall? 12 A I regularly read the Journal of Urology 13 and what we call the Gold Journal, which is 14 urology. 15 Q All right. So here's a list. The Gold 16 Journal? 17 A Yes, Urology. 18 Q Okay. And what were the others? 19 A Journal of Urology. 20 (Defendants' Exhibit 7 was marked.) 21 Q Okay. I'm going to hand you Exhibit 7, 22 and this is list of journal articles. 23 MR. SAUNDERS: Could we take a break 24 for a minute? 25 MS. POPE: Yeah, let me finish this Page 47 1 question. 2 MR. SAUNDERS: Okay. Go ahead. 3 BY MS. POPE: 4 Q On Exhibit 7 it's a list of articles 5 regarding TVT. And if you could look at this 6 list, perhaps looking at Page 2, that encompasses 7 the 2006, 2007 timeframe and identify any articles 8 you may have read prior to the implant in 2008. 9 For example, there's a Journal of 10 Urology article listed on the bottom of Page 2 11 from 2007. 12 A Yes. 13 Q Would you -- do you believe you would 14 have read that? 15 A I think so, yes. 16 Q All right. And there's also a Journal 17 of Urology 2005 article described towards the top? 18 A Yes. 19 Q Do you recall reviewing that article? 20 A Again, that's 2005. That's over ten 21 years ago. So if it was in the Journal of 22 Urology, I probably did read it. 23 Q Okay. Because you're a member of the 24 American Urological Association? 25 A Well, no, because I read the Journal of Page 48 1 Urology occasionally. 2 Q Okay. Well, fair enough. 3 MS. POPE: Let's take a break. We're 4 off the record. 5 THE VIDEOGRAPHER: Off the record 9:58. 6 (Thereupon, a break was taken.) 7 THE VIDEOGRAPHER: On the record 10:06. 8 (Defendants' Exhibit 8 was marked.) 9 BY MS. POPE: 10 Q Doctor, I'm going to hand you what 11 we've marked as Exhibit 8, so we are done with 12 those exhibits that are currently in front of you. 13 A Okay. 14 Q And this is a chart entitled 'Potential 15 Risks of Non-mesh SUI Surgery'. Just take a 16 moment to read over the potential risks of 17 non-mesh SUI surgery. And when you are done 18 reading that, let me know. 19 A Okay. 20 Q Are you aware of all of the risks 21 listed under the column non-mesh? 22 A Yes. 23 Q Were you aware of these risks at the 24 time of Mrs. Suter's TVT surgery? 25 A Yes. Page 49 1 Q Were you aware at the time of 2 Mrs. Suter's TVT surgery that these risks could be 3 either temporary or chronic in nature? 4 A Yes. 5 Q And were you aware at the time of her 6 surgery that these risks could be mild, moderate 7 or severe? 8 A Yes. 9 (Defendants' Exhibit 9 was marked.) 10 Q I'm going to hand you what I've marked 11 as Exhibit 9, which is another chart, and this one 12 is entitled 'Potential Risks of Non-mesh and Mesh 13 SUI Surgeries' and ask you to take a look at that. 14 A Yes. Okay. 15 Q Doctor, are you aware that all of the 16 risks listed under the column mesh could be 17 potential risks of mesh SUI surgery? 18 A Of non-mesh and mesh, yes. 19 Q Yes. And were you aware of these risks 20 of mesh and non-mesh before the Plaintiff's TVT 21 surgery? 22 A Yes. 23 Q Were you aware before the Plaintiff's 24 TVT surgery that the risks listed under mesh could 25 be temporary or chronic in nature? Case 2:12-cv-01712 Document 51-2 Filed 07/08/16 Page 10 of 17 PageID #: 333 John Patterson, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 14 (Pages 50 to 53) Page 50 1 A Yes. 2 Q Similarly were you aware before her 3 surgery that the risks listed under the mesh 4 column could be mild, moderate or severe? 5 A Yes. 6 (Defendants' Exhibit 10 was marked.) 7 Q I'm going to hand you Exhibit 10, and 8 this an information for use or sometimes it's 9 referred to as the package insert. And this I 10 will represent was the one in effect at the time 11 of the implant. 12 Doctor, do you remember the last time 13 you read the TVT information for use or IFU? 14 A Probably at one of the original 15 meetings. 16 Q Original meetings where you were 17 trained? 18 A Where we were trained and instructed on 19 TVT. 20 Q All right. So when you were first 21 learning about TVT, you probably read the IFU? 22 A Yes. 23 Q All right. Based on your training, did 24 you find the IFU to be adequate for your purpose? 25 A Yes. Page 51 1 Q Did you read the IFU to learn 2 procedural steps on how to properly implant the 3 device? 4 A I think that more from experience and 5 training. 6 Q So your clinical experience guides you 7 more? 8 A Yes. 9 Q All right. Do you read the IFU on a 10 regular basis? 11 A No. 12 Q Does the IFU come in every package when 13 you use a TVT in the operating room? 14 A Yes. 15 Q When you performed Mrs. Suter's 16 surgery, did you take the TVT IFU out of the box 17 in the operating room, open it up and read it -- 18 A No. 19 Q -- before you implanted her TVT? 20 A No. 21 Q Doctor, one of the allegations in this 22 case is that the presence or absence of particular 23 words in the IFU describing the risks of TVT would 24 have changed your decision to prescribe the TVT 25 for Mrs. Suter. Were you aware of that? Page 52 1 A No. 2 Q All right. Based on your education, 3 training and clinical experience and your review 4 of the medical literature over the years, are 5 there any complications that Mrs. Suter 6 experienced that you were not aware of prior to 7 implanting the TVT? 8 A No. 9 Q So to review, you were aware of the 10 potential complications of dyspareunia? 11 A Yes. 12 Q And pelvic pain? 13 A Yes. 14 Q And erosion? 15 A Yes. 16 Q Now, if you take a look at Exhibit 9, 17 which is right underneath there (indicating), if 18 Ethicon had included in Exhibit 9 under the mesh 19 column -- if Ethicon had included in the TVT IFU 20 the words found under the mesh column in 21 Exhibit 9, is it correct to say that those 22 additional words would not have changed your 23 decision to prescribe TVT for the Plaintiff? 24 A No. 25 Q Is that correct? Page 53 1 A That is correct. 2 Q All right. I'm going to ask you some 3 questions about the mesh that's in the TVT device. 4 A Okay. 5 Q Can you tell the jury what a foreign 6 body reaction is? 7 A Well, it's a -- a foreign body is 8 something that is implanted and that is not 9 normally in the body, and the body senses that as 10 being foreign or not natural, and it creates an 11 inflammatory response -- 12 Q And that -- 13 A -- with it, scarring. 14 Q I'm sorry. And that inflammatory 15 response would occur regarding any foreign object 16 implanted whether it's a pacemaker, a knee implant 17 or a mesh implant? 18 A Yes. 19 MR. SAUNDERS: Objection to the form. 20 MS. POPE: What's your objection? 21 MR. SAUNDERS: To the form. 22 MS. POPE: Specifically? 23 MR. SAUNDERS: Leading. 24 MS. POPE: Leading? 25 BY MS. POPE: Case 2:12-cv-01712 Document 51-2 Filed 07/08/16 Page 11 of 17 PageID #: 334 John Patterson, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 18 (Pages 66 to 69) Page 66 1 MS. POPE: Can we go off the record? 2 THE VIDEOGRAPHER: Off the record 3 10:24. 4 (Thereupon, a break was taken.) 5 THE VIDEOGRAPHER: On the record 10:25. 6 BY MS. POPE: 7 Q Doctor, can you say with any reasonable 8 degree of medical certainty that the Plaintiff 9 would not have developed complications if you 10 would have implanted a strip of larger pore, 11 lighter weight mesh in her as opposed to TVT? 12 A I don't have any basis to say yes or no 13 to that hypothetical. 14 Q Doctor, have you followed patients who 15 have had a TVT device implanted for a number of 16 years? 17 A Yes. 18 Q Have the majority of your patients who 19 have had a TVT implanted had no complications? 20 MR. SAUNDERS: Object to the form. 21 A Yes, they have had no complications. 22 Q Okay. Have you had a good experience 23 or a bad experience with the TVT? 24 A Good experience. 25 Q Has it ever improved the quality of Page 67 1 your patient's lives? 2 A Absolutely. 3 Q To your knowledge does the medical 4 literature show that the product at issue, the 5 TVT, is safe and effective? 6 A Yes. 7 Q Have you ever used any TVT product 8 other than the standard TVT? 9 A I've done some TVT-Secur and then the 10 TVT Advantage has come out with a smaller trocar 11 size. Not a big advantage really I think with 12 larger or smaller trocars other than maybe a 13 little less immediate postoperative pain. 14 The TVT-Secur I had good results with 15 it, but the literature did indicate that there 16 might be a slight decrease in durability long term 17 with that. 18 Q And as I understand it is the TVT-Secur 19 generally considered to be a less invasive 20 procedure? 21 A Yes, it's a single incision sling. 22 Q Does the TVT implant that you use in 23 your practice provide good clinical benefit to 24 your patients? 25 A Yes. Page 68 1 Q And was that true before you implanted 2 that device in Mrs. Suter? 3 A Yes. 4 Q Currently are you still experiencing 5 good clinical results in your patients? 6 MR. SAUNDERS: Object to the form. 7 A Yes. 8 Q Currently can you describe for me the 9 clinical results your patients are reporting after 10 you implant TVT? 11 MR. SAUNDERS: Object to the form. 12 A Well, I think, you know, we're getting 13 a good response with improvement of stress urinary 14 incontinence either no or much improved 15 incontinence with a minimum of pain and 16 discomfort. 17 Q At the time of Mrs. Suter's implant, 18 did the TVT have an acceptable risk profile for 19 the benefits you were hoping to achieve? 20 A Yes. 21 Q Putting yourself back at the time you 22 implanted Mrs. Suter but with the knowledge that 23 you have today, do you agree that TVT was a safe 24 and effective treatment for SUI in women? 25 A Well, I'm still doing them, so I still Page 69 1 feel like it's the best procedure. 2 Q Putting yourself back at the time you 3 implanted Mrs. Suter, but again based on the 4 information and knowledge you have as you sit here 5 today, do you agree that the potential benefits of 6 using TVT to treat SUI outweigh any potential 7 risks? 8 A I do. 9 Q Do you believe that the mid-urethral 10 slings, and specifically TVT, have been the Gold 11 Standard for treating SUI? 12 A I think so. 13 Q Doctor, to the extent you've given 14 opinions today, are they all within a reasonable 15 degree of medical probability or certainty? 16 A I think so, yes. 17 MS. POPE: And those are all the 18 questions I have for you at this time, and 19 I'll reserve any remaining time I have for 20 follow-up in rebuttal. 21 Do we -- we can go off the record? 22 MR. SAUNDERS: Sure. 23 THE VIDEOGRAPHER: Okay. We're closing 24 the record at 10:29. 25 MS. POPE: We're not closing the Case 2:12-cv-01712 Document 51-2 Filed 07/08/16 Page 12 of 17 PageID #: 335 John Patterson, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 20 (Pages 74 to 77) Page 74 1 Q You've seen sections like this entitled 2 'Adverse Reactions' in product labeling and in 3 brochures in your practice, don't you? 4 A Yes. 5 Q What's the purpose of a manufacturer 6 providing a section labeled 'Adverse Reactions'? 7 MS. POPE: Object. Lack of foundation. 8 A Well, I mean it's what are the possible 9 problems that could occur with the implantation 10 so... 11 Q And is that to help you communicate to 12 the patient possible problems of a device? 13 A You know, I -- I don't put a lot of 14 stock in that from a company. I look at the 15 literature. I look at what has been -- what we 16 see in the studies that HAD been done by 17 independent sources and my own personal experience 18 with the product, and then that's what I go by. 19 Obviously that is going to encompass those things. 20 Q Sure, sure. And you would expect 21 Ethicon to provide you with adverse reactions that 22 they reasonably know about at the time they 23 provide you with that warning, wouldn't you? 24 A Yes, yes. 25 Q And as a physician is it your Page 75 1 understanding that's an ethical responsibility of 2 the Company to provide you information if they 3 know about it at the time? 4 MS. POPE: Object to the form. 5 A Well, all of those -- you know, any 6 study that they would do is public knowledge and 7 in the literature so, yes. 8 Q And if -- in 2008 when you performed 9 Mrs. Suter's surgery, if Ethicon knew that this 10 product had caused chronic pain during sex, you 11 would expect them to put that in the patient 12 brochure, wouldn't you? 13 A Well, all the other procedures that are 14 done have the same potential side effect. 15 Q My question, though, is if -- if the 16 Company internally knew that there were 17 significant instances of chronic -- 18 A So you think that this is more -- more 19 -- more occurs with this product than occurs with 20 any other procedure? 21 Q No, I'm not really saying that. 22 A Well, that's what you would be saying 23 if you said that. 24 Q Okay. Let me ask it this way: In the 25 second part here of the adverse reactions it says, Page 76 1 "Transitory local irritation at the wound site and 2 a transitory foreign body response may occur. 3 This response could result in extrusion, erosion, 4 fistula formation or inflammation." Do you see 5 that part? 6 A Yes. 7 Q What's your interpretation of 8 transitory local irritation? 9 A Well, it would hopefully be time 10 limited, yeah. 11 Q As opposed to chronic? 12 A Chronic. 13 Q And so would you agree that this 14 suggests that these complications that are 15 discussed here, transitory local irritation at the 16 wound site and transitory foreign body response, 17 suggests that these are time limited events? 18 MS. POPE: Object to the form. 19 A Well, they would result in extrusion, 20 erosion or fistula formation, so I think that we 21 would find -- find out over time what -- if that 22 would -- if that local irritation or the foreign 23 body response was chronic, that it would result in 24 these other things. That's the way I interpret 25 it. Page 77 1 Q But if the Company knew that there was 2 a risk of chronic problems such as this, you would 3 expect them to put in the literature that it was 4 chronic rather than transitory, wouldn't you? 5 MS. POPE: Object to the form. 6 A I think we're splitting hairs is what I 7 would interpret that. 8 Q Well, chronic is different than 9 transitory, isn't it? 10 A If you had extrusion, erosion or 11 fistula formation, that's not transitory so... 12 Q Well, the language says transitory 13 here, doesn't it? 14 A Okay. Well, we can split hairs. I 15 mean you can interpret it whatever way you want. 16 Q Well, let me ask it this way: As a 17 physician you want to be fair in communicating 18 risks and benefits to patients, don't you? 19 A Yes. 20 Q And you're not a salesman for a 21 product, are you? 22 A That's correct. 23 Q Your -- as I understand it as a 24 physician and as you've testified here your duty 25 is to the patient, to find the best thing for the Case 2:12-cv-01712 Document 51-2 Filed 07/08/16 Page 13 of 17 PageID #: 336 John Patterson, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 21 (Pages 78 to 81) Page 78 1 patient. 2 A Yes. 3 Q Is that accurate? 4 A Yes. 5 Q And to do that one of those things is 6 to get -- properly advise the patient of possible 7 poor outcomes that might occur? 8 A That's correct. 9 Q And there are a number of reasons why 10 poor outcomes can occur, aren't there? 11 A Uh-huh (affirmative), yes. 12 Q And in any medical procedure, there can 13 be a poor outcome that's not anybody's fault, 14 isn't there? 15 A That's correct. 16 Q And part of your task as a physician is 17 to discuss with patients so that they give you 18 informed consent to the procedure; isn't that 19 correct? 20 A Correct. 21 Q And if Ethicon knew that there were 22 problems of chronic painful sex associated with 23 the TVT, that's something that you would want to 24 discuss with a patient, wouldn't you? 25 A Well, and we do with any pelvic Page 79 1 surgery. 2 Q Okay. And you testified that you used 3 these brochures to help communicate to patients 4 the risks and benefits of a product, correct? 5 A In addition to discussing these things 6 with them. 7 Q Okay. 8 A That's something that they can take 9 home. 10 Q Certainly. 11 A Yeah. 12 Q And in this document that you give to 13 your patients to take home here, it doesn't say 14 anything about painful sex, does it? 15 A I don't see anything specifically 16 there. 17 Q Okay. Okay. And if Ethicon had 18 knowledge in 2008 that there were instances of 19 painful sex associated with this, you would expect 20 them to share that with you as a physician, 21 wouldn't you? 22 MS. POPE: Object to the form. 23 A I think it's well -- well documented 24 without putting it in the -- in this -- in that 25 document. It's well documented in the literature. Page 80 1 Q Well, it's well -- it's well documented 2 in the literature as you've testified. But as far 3 as your communication with the patient, the 4 patient doesn't have access to the literature, do 5 they? 6 A Sure, they do. They could look it up. 7 Q Okay. 8 A The Internet was available in 2008 and 9 they usually do. 10 Q Okay. Do you expect your patients to 11 do medical research in the literature? 12 A No. 13 Q Okay. Would it be fair to say that you 14 try to provide them yourself a fair and balanced 15 assessment, from your point of view, of the risks 16 and benefits; is that correct? 17 A That's correct, yes. 18 Q And part of the information you share 19 with them is this brochure provided by -- 20 A Part of it. 21 Q -- Ethicon? 22 A Part of it. 23 Q And while there can be side effects 24 from any general surgery, which you've agreed that 25 there is and that you share with patients, if Page 81 1 there are additional risks inherent in a 2 particular product, that's something that you 3 would want to share with a patient as well as the 4 general risks, wouldn't it? 5 A Yes. 6 Q And if Ethicon had special knowledge 7 internally of some special risks associated with 8 their product, you would want to know that to 9 share that with the patient, wouldn't you? 10 A Yes. 11 Q And in the brochure that Ethicon 12 provided you for your patients, they did not 13 make any mention of painful sex, did they? 14 A I don't see that in the adverse 15 reactions. 16 Q And they made no reference to any 17 chronic conditions in the adverse reactions. In 18 fact, they suggested twice that it was transitory, 19 didn't they? 20 MS. POPE: Object to the form. 21 A That's what it -- that's what it says. 22 Q So would you agree that that could be 23 misleading to a patient? 24 A That's hypothetical. It could be. 25 Q In your practice working with the mesh, Case 2:12-cv-01712 Document 51-2 Filed 07/08/16 Page 14 of 17 PageID #: 337 John Patterson, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 24 (Pages 90 to 93) Page 90 1 you. The data was unconvincing as to the 2 difference. 3 Q Were you aware, though, before today 4 that Ethicon did offer a laser cut TVT mesh? 5 A I am not aware of whatever -- what 6 theirs is. 7 Q And if Ethicon had data internally 8 about risks and benefits versus machine cut and 9 laser, you'd expect them to share that with you if 10 it was significant, wouldn't you? 11 A I would expect them to market that to 12 me as being advantageous, yes. 13 Q And if they were significant, that's 14 something you might discuss with the patient as 15 well, wouldn't you? 16 A That's correct, yes. 17 Q If Ethicon had internal data before 18 2008 that degradation of the polyethylene was a 19 significant concern to Ethicon, you would expect 20 them to share that information with you as a 21 physician, wouldn't you? 22 A Yes. 23 Q And that's information that you would 24 share with a patient as well, wouldn't you? 25 A If it was significant, yes. Page 91 1 Q In Exhibit 4, which was the patient 2 chart that you discussed earlier in your 3 deposition, if you can take a look at that on 4 Page 11. It's marked in Sharpie, Page 11 there. 5 In your visit of 5/20/10, did Mrs. Suter report to 6 you having painful sex? 7 A Yes. 8 Q And is that notated where it says also 9 having -- 10 A Dyspareunia. 11 Q -- dyspareunia. That refers to painful 12 sex and that she reported that to you? 13 A Yes. 14 MR. SAUNDERS: I don't have any further 15 questions. Thank you very much. 16 THE WITNESS: Okay. 17 MS. POPE: Can we just take a small 18 break? 19 MR. SAUNDERS: Sure. 20 MS. POPE: I just have a short rebuttal 21 and then we'll -- 22 MR. SAUNDERS: Okay. Very well. 23 THE VIDEOGRAPHER: Off the record 24 11:06. 25 (Thereupon, a break was taken.) Page 92 1 THE VIDEOGRAPHER: On the record 11:14. 2 REDIRECT EXAMINATION 3 BY MS. POPE: 4 Q Doctor, you were asked some 5 questions by Plaintiffs' counsel about your 6 informed consent process. Is it fair to say 7 that when you have discussions with patients 8 looking back on 2008, that your discussions 9 are informed by a variety of things, for example, 10 your clinical experience? 11 A Yes. 12 Q And your review of medical journals and 13 other literature? 14 A Yes. 15 Q The information you learned in your 16 internship and residency? 17 A Yes. 18 Q So would a company product brochure 19 just be one tool of many that you would use in 20 having discussions with a patient including 21 Mrs. Suter? 22 A Yes. 23 Q Let me have you look at Exhibit 9, 24 and we discussed that. This is the chart 25 that lists potential risks of non-mesh and Page 93 1 mesh SUI surgeries. Do you recall our 2 discussion about that at the beginning of the 3 deposition? 4 A Yes. 5 Q And I believe you told me you were 6 aware of the risks that are listed under the mesh 7 column before the time you implanted -- 8 A Yes. 9 Q -- Mrs. Suter with her TVT; is that 10 correct? 11 A Yes. 12 Q Were you also aware that all those 13 risks listed there could be either temporary or 14 chronic? 15 A Well, it says acute or chronic pain. 16 Q Acute or chronic. 17 A That's the main -- 18 Q Right. 19 A Yeah. Well, I think you assume that 20 that's -- if not directly specified, you assume 21 that it's acute or chronic, yes. 22 Q Okay. And in fact then would you have 23 been aware that pain with intercourse was a 24 potential risk of surgery with mesh or without 25 mesh? Case 2:12-cv-01712 Document 51-2 Filed 07/08/16 Page 15 of 17 PageID #: 338 John Patterson, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 25 (Pages 94 to 97) Page 94 1 A Yes. 2 Q And that -- 3 A Yes. 4 Q And that pain with intercourse could be 5 temporary or chronic; is that right? 6 A Yes. 7 Q In the discussions you had with 8 Mrs. Suter regarding possible risks and 9 complications and benefits of TVT, would you have 10 explained various risks to her regardless of 11 whether you thought she was a high responder or a 12 low responder? 13 A Well, I don't know how to 14 stratify somebody as a high responder 15 or a low responder, so there wouldn't be a 16 discussion about that. 17 Q So when you sit down with the patient, 18 you don't evaluate whether they are a high 19 responder, a low responder in deciding what risks 20 to talk to them about? 21 A No. I think that I talk to them 22 about -- about the risks equally. I mean I 23 don't know what a high responder versus a low 24 responder is. I mean it may be a smoker or, 25 you know... Page 95 1 Q In your practice is it your practice to 2 explain to patients risks and benefits of 3 procedures including mesh regardless of how you 4 might characterize them in terms of their pain 5 threshold? 6 A Well, yes. I mean if they've got -- 7 you know, if they have chronic pain -- we used to 8 talk about with patients who were on the 9 anticholinergic medications that they'd have a dry 10 mouth. But if they already had a dry mouth, how 11 much drier can it be? 12 You know, so it's a similar type 13 situation here. If they've got chronic pain, is 14 that going to make the chronic pain worse, how 15 much worse? 16 You know, I think you tell them that's 17 a possibility, but I can't grade it as to how much 18 more it would be or less or... 19 Q But the point is you tell them? 20 A The point is we talk about it, yes. 21 Q You were asked some questions about a 22 mesh called Vypro. Have you ever heard of Vypro 23 mesh? 24 A I have never heard of Vypro. 25 Q Have you ever used it? Page 96 1 A No. 2 Q Do you know what it's made of? 3 A No. 4 Q Do you have any reason to believe that 5 a sling made of Vypro would have been a safer 6 alternative device for Mrs. Suter as opposed to 7 the TVT? 8 A No. 9 Q Do you believe that the TVT has an 10 adequate pore size? 11 A I do. 12 Q You were asked a question at the end 13 about dyspareunia, which is pain during 14 intercourse; is that right? 15 A That's correct. 16 Q Are there a variety of things that can 17 cause dyspareunia? 18 A Yes, a lot of things. 19 Q Do you ever treat women in your 20 practice who have dyspareunia? 21 A We do sometimes with estrogen. If 22 certainly they are postmenopausal with atrophic 23 vaginitis, a lot of times we'll talk to our 24 gynecologic colleagues about that. 25 Q Do the women you or your gynecological Page 97 1 colleagues treat who experience dyspareunia 2 necessarily have mesh? 3 A No, many of them don't. 4 Q So if you or your gynecological 5 colleagues prescribe estrogen, what is that for? 6 A Well, it's supposed to -- the feeling 7 is with atrophic vaginitis the lack of estrogen 8 stimulation, the vaginal tissues are thinner and 9 dryer and more sensitive. 10 Q Is atrophic vaginal dryness something 11 that can occur in a woman in menopause? 12 A Yes. 13 Q And is that particularly true if the 14 woman is not taking hormone replacement? 15 A Yes. 16 MS. POPE: I believe those are all the 17 questions I have for you at this time. 18 THE WITNESS: Okay. 19 MR. SAUNDERS: I just have a couple to 20 follow-up here. 21 THE VIDEOGRAPHER: Off the record 22 11:21. 23 (Thereupon a break was taken.) 24 THE VIDEOGRAPHER: On the record 11:21. 25 RECROSS-EXAMINATION Case 2:12-cv-01712 Document 51-2 Filed 07/08/16 Page 16 of 17 PageID #: 339 John Patterson, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 26 (Pages 98 to 101) Page 98 1 BY MR. SAUNDERS: 2 Q Doctor, I just have a couple of more 3 follow-up questions here. 4 A minute ago you mentioned that you 5 thought that the Ethicon TVT mesh had an adequate 6 pore size in response to Defense questions. 7 Now, would you agree that Ethicon has 8 more expertise internally about the biomechanics 9 of pore size than you do in your practice? 10 A I think so, yes. 11 Q And it's not really a focus -- would 12 you agree that it's not really a focus of what you 13 do to evaluate pore sizes? 14 A Yes, that's correct. 15 Q And if Ethicon internally had some 16 serious concerns about pore size and safety that 17 were significant, you would expect them to share 18 that with you, wouldn't you? 19 A Yes. 20 Q And that would be important to you in 21 evaluating which type of mesh would be best for 22 your patients, wouldn't it? 23 A Yes. 24 MR. SAUNDERS: I don't have any further 25 questions. Thank you. Page 99 1 THE VIDEOGRAPHER: We're closing the 2 record at 11:22. 3 4 (Thereupon, the deposition 5 concluded at 11:22 a.m.) 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 100 1 STATE OF KENTUCKY ) 2 COUNTY OF MONTGOMERY ) 3 I, JANINE N. LEROUX, Court Reporter and 4 Notary Public in and for the State of Kentucky at 5 Large, certify that the facts stated in the 6 caption hereto are true; that at the time and 7 place stated in said caption the witness named in 8 the caption hereto personally appeared before me, 9 and that, after being by me duly sworn, was 10 examined by counsel for the parties; that said 11 testimony was taken in stenotype by me and later 12 reduced to computer-aided transcription and the 13 foregoing is a true record of the testimony given 14 by said witness. 15 The foregoing deposition has been 16 submitted to the witness for reading and signing. 17 18 19 20 21 22 _______________________________ 23 JANINE N. LEROUX, CCR(KY) 24 NOTARY PUBLIC 25 MY COMMISSION EXPIRES: 1/21/20 Page 101 1 2 - - - - - - 3 E R R A T A 4 - - - - - - 5 6 PAGE LINE CHANGE 7 ____ ____ ____________________________ 8 REASON: ____________________________ 9 ____ ____ ____________________________ 10 REASON: ____________________________ 11 ____ ____ ____________________________ 12 REASON: ____________________________ 13 ____ ____ ____________________________ 14 REASON: ____________________________ 15 ____ ____ ____________________________ 16 REASON: ____________________________ 17 ____ ____ ____________________________ 18 REASON: ____________________________ 19 ____ ____ ____________________________ REASON: ____________________________ 20 ____ ____ ____________________________ 21 REASON: ____________________________ 22 ____ ____ ____________________________ 23 REASON: ____________________________ 24 ____ ____ ____________________________ 25 REASON: ____________________________ Case 2:12-cv-01712 Document 51-2 Filed 07/08/16 Page 17 of 17 PageID #: 340 EXHIBIT C Case 2:12-cv-01712 Document 51-3 Filed 07/08/16 Page 1 of 12 PageID #: 341 Danielle M. Mann, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS Page 1 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF WEST VIRGINIA AT CHARLESTON IN RE: ETHICON, INC., Master File No. 2:12-MD-02327 PELVIC REPAIR SYSTEM MDL 2327 PRODUCTS LIABILITY LITIGATION JOSEPH R. GOODWIN U.S. DISTRICT JUDGE __________________________________________________ CAROL & TROY SUTER, Plaintiffs, Case No. 2:12-cv-01712 v. ETHICON, INC. ET AL., Defendants. ____________________________________________________ WITNESS: DANIELLE M. MANN, M.D. ____________________________________________________ The video deposition of Danielle M. Mann, M.D. was taken before Janine N. Leroux, Stenographic Court Reporter and Notary Public - in and for the State of Kentucky at Large, at the office of Dr. Danielle M. Mann located at Barker & Moloney, 333 West Main Street, 1023 New Moody Lane, La Grange, Kentucky on Wednesday, May 4, 2016, commencing at the approximate hour of 12:27 p.m. Said deposition was taken pursuant to Notice. Case 2:12-cv-01712 Document 51-3 Filed 07/08/16 Page 2 of 12 PageID #: 342 Danielle M. Mann, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 7 (Pages 22 to 25) Page 22 1 gone through them. 2 A Okay. This is the first one. 3 Q It does say new patient in someone's 4 handwriting so that also was a helpful clue. 5 A Okay. 6 Q But if it's helpful to you to look at 7 the original -- 8 A I'm just looking to see if that's what 9 I agree with. Yes, and I agree. 10 Q Okay. Okay. And on a number of the 11 progress notes for various visits, it looks like 12 at the beginning there is one person's handwriting 13 and then after that someone else's handwriting? 14 A Yes. 15 Q Is that typical? 16 A Yes. 17 Q Who would the handwriting toward the 18 top of the progress notes be? 19 A Medical assistant putting in the 20 weight, blood pressure, asking last menstrual 21 period and chief complaint. 22 Q Okay. And then would the rest of it be 23 yours? 24 A Yes. 25 Q Okay. So just to make sure that I -- Page 23 1 your handwriting is pretty nice, and I can read 2 most of it, but there were a few that I'll have 3 questions about. 4 But just to make sure that I have 5 understood it, for most of these I'm going to ask 6 you to read through them just so we get it on the 7 record. 8 So skipping down we've got the weight, 9 the blood pressure, last menstrual period. It 10 indicates she's had a hysterectomy, so she's not 11 having periods, correct? 12 A Yes, yes. 13 Q Okay. What's right under LMP? 14 A Urine pregnancy test and it's crossed 15 off because she's had a hysterectomy. 16 Q Okay. And then below that is her 17 complaint. Can you read what that is, please? 18 A "Complaining of abdominal pain. CT 19 scan at a hospital in Shelbyville." 20 Q Okay. So she had already had a CT scan 21 when she came to you? 22 A Uh-huh (affirmative). 23 Q Okay. And then if you wouldn't mind 24 just reading through starting there with your 25 handwriting the notes, and I may stop you at a Page 24 1 couple places with some questions. 2 A Okay. So I wrote that she has a 3 history of total a total abdominal hysterectomy 4 secondary to a fibroid uterus. She's complaining 5 of dyspareunia or pain with intercourse. She 6 states that the pain is in the lower abdomen for 7 about a year. 8 Q Okay. And so a total abdominal 9 hysterectomy that's removal of the uterus and the 10 cervix, correct? 11 A Yes. 12 Q Okay. And that's done through an 13 incision in the lower abdomen, correct? 14 A Yes. 15 Q Okay. And she said that -- she 16 reported to you that she had the hysterectomy 17 because of a fibroid uterus? 18 A Yes. 19 Q What is a fibroid uterus? 20 A A fibroid is a benign tumor of the 21 uterus. It usually can cause the uterus to be 22 enlarged, and it's usually associated with heavy 23 menstrual periods. 24 Q Okay. What causes a fibroid uterus? 25 Do we know? Page 25 1 A 50 percent of women have them. 2 Q Okay. It's a matter of degree I guess 3 in women? 4 A Yes. 5 Q Okay. 6 A Yes. Some are large, some are small. 7 It depends where they are. They can be intramural 8 or inside the bed of the uterus. They can be 9 submucosal. They can be subserosal. So depending 10 on where they are, the symptoms can change. 11 Q Okay. So the different types you just 12 mentioned some would be intramural would be within 13 the wall of the uterus? 14 A Uh-huh (affirmative), yes. 15 Q Some would be -- would some be in the 16 interior of the uterus? 17 A So subserosal meaning that it's 18 impinging on the inside of the endometrial cavity, 19 which can cause significantly heavy periods. 20 Q Okay. Okay. So if you could go on 21 from there, please. 22 A I wrote her gynecologic history. She 23 had had a Pap smear approximately two years ago, 24 and she had no history of abnormal Paps, and she 25 had no abnormal pathology from the total abdominal Case 2:12-cv-01712 Document 51-3 Filed 07/08/16 Page 3 of 12 PageID #: 343 Danielle M. Mann, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 8 (Pages 26 to 29) Page 26 1 hysterectomy. 2 Her last mammogram was in February of 3 2010 and was normal. 4 Q Okay. And then did you do a physical 5 exam? 6 A I did. 7 Q Okay. If you could read us what that 8 says. 9 A I wrote heart, "Regular rate and 10 rhythm. Lungs clear to auscultation bilaterally. 11 Abdomen soft with tenderness. Diffuse in pelvis. 12 Vaginal exam with right lower quadrant and left 13 lower quadrant pain. No masses palpated." 14 Q Okay. So when you say that there was 15 tenderness diffuse in the pelvis, that means it 16 wasn't particularly localized in any one 17 particular location? 18 A Just lower, not necessarily abdominal. 19 So when I say pelvis, I mean lower part of the 20 abdomen. 21 Q Okay. So she had sort of, as you say, 22 diffuse tenderness? 23 A In a specific area. 24 Q Pain. Okay. Go ahead. 25 A So assessment and plan, "42 year old Page 27 1 with pelvic pain. My first issue is gynecologic 2 maintenance. No Pap smear indicated. Mammogram 3 up to date. 4 Second issue. Pelvic pain. Etiology 5 unknown. Multiple abdominal surgeries. 6 Questionable adhesions. Transvaginal ultrasound 7 with a 2.3 centimeter cyst on the right ovary, 8 otherwise normal. 9 Plan for diagnostic laparoscopy. Risks 10 of procedure reviewed including bleeding, 11 infection, damage to bowel and bladder." 12 Q Okay. So did you do an ultrasound then 13 in the office? 14 A Possibly. I'll have to see. I don't 15 remember. I don't know if that came to me. Yes, 16 it looks like it did. No, I'm sorry. I don't 17 know if that's the one that I got from her 18 hospital, and she thought it was a CT scan, and it 19 was from the other hospital. 20 Let's see here, sometimes people think 21 it's a CT scan. 22 Q Sure. 23 A Here it is. Yes, she had it done at 24 Jewish Hospital Shelbyville. It was not actually 25 a CT scan. It was an ultrasound. Page 28 1 Q Okay. 2 A And it says, "Uterus absent. No free 3 fluid in the pelvis. There are multiple small 4 bilateral ovarian cysts consistent with 5 physiological cysts. The largest is in the right 6 ovary measuring 2.3 centimeters. No suspicious 7 ovarian mass." 8 Q Okay. So at this point in your 9 assessment on this date -- and I don't know if I 10 read the date but it's November 17th of 2010 is 11 the office visit we're talking about. She's 12 having pelvic pain and you say etiology unknown. 13 A Uh-huh (affirmative). 14 Q You don't know the source of it? 15 A Huh-uh (negative). 16 Q You do note that she's had multiple 17 abdominal surgeries? 18 A Uh-huh (affirmative). 19 Q She's had a hysterectomy. I'm not sure 20 if it's noted here but I know it's elsewhere in 21 your records that she also had two -- 22 A Two C-sections. 23 Q -- Caesarean sections, yes. 24 A Uh-huh (affirmative). 25 Q And you have questionable adhesions? Page 29 1 A Uh-huh (affirmative). 2 Q Is that -- do you know what that's 3 based on? Is that something that can be seen on 4 an ultrasound? 5 A No. 6 Q Okay. Is that because she's had 7 multiple abdominal surgeries? 8 A Yes. 9 Q And that is -- 10 A And diffuse pain, yeah. 11 Q And in someone who has had multiple 12 abdominal surgeries, there's a good chance they 13 are going to have adhesions of some sort, correct? 14 A Some people do; some people don't. 15 Q Okay. Were you aware at this point 16 that Ms. Suter had had a TVT sling implanted in 17 2008? 18 A I don't believe so because she did not 19 write it on her surgeries. 20 Q And you're looking at a patient history 21 that she filled out? 22 A Yes, she filled out, yes. 23 Q Okay. 24 A So I don't believe that I knew at this 25 point that she had had it. Case 2:12-cv-01712 Document 51-3 Filed 07/08/16 Page 4 of 12 PageID #: 344 Danielle M. Mann, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 10 (Pages 34 to 37) Page 34 1 two additional port sites to be my hands. 2 Q Okay. So what are abdominal adhesions 3 or pelvic adhesions? 4 A Adhesions occur any time that you have 5 any sort of pelvic infection or any time you have 6 any sort of surgery. Any time there's blood in 7 that area, it can increase your risk for 8 adhesions. Adhesions basically means scar tissue 9 where things that are stuck together. 10 Q Okay. And so when you have scar 11 tissue, that could be from prior abdominal or 12 pelvic surgeries, correct? 13 A Of course, yes. 14 Q Okay. And is that the most common 15 cause of pelvic adhesions or abdominal adhesions? 16 A Infection, also. 17 Q Infection and prior trauma from 18 surgery? 19 A Uh-huh (affirmative). 20 Q Okay. Can adhesions that form from 21 prior surgeries, can they enlarge over a period of 22 time over the years after the surgery? 23 A Sure. I mean a lot of times we don't 24 know what's happening inside somebody's belly, so 25 I can't really say. Page 35 1 Q So you don't know what they look like 2 at the beginning? 3 A I don't know, yeah. 4 Q Okay. Can -- in your experience, can a 5 patient who has had a prior abdominal surgery some 6 years ago be asymptomatic from the adhesions and 7 then over the years become symptomatic? 8 A I guess because I don't know when the 9 adhesions start forming and when it becomes 10 symptomatic for someone. 11 Q Okay. You don't know until you look 12 that they have adhesions? 13 A Exactly. I just can't say, yeah. 14 Q Okay. And when you say things that -- 15 adhesions can also be things stuck together, does 16 that include the internal organs? 17 A Bowel can be stuck to the interior 18 abdominal wall, the omentum, which is the fatty 19 layer over bowel, can be stuck to places, ovaries, 20 uterus, fallopian tubes. 21 Previous C-sections can increase risk 22 for bladder being stuck to the uterus or something 23 else depending if the uterus isn't there or not 24 so... 25 Q And in Ms. Suter's case, did she have Page 36 1 organs that were either stuck to the abdominal 2 walls or to one another? 3 A Yes, she had significant adhesions. 4 Q Okay. What kind of symptoms can 5 adhesions cause? 6 A Pain. 7 Q Pelvic -- the type of pelvic pain that 8 Ms. Suter had? 9 A Yes. 10 Q Can they cause pain with intercourse? 11 A Yes. 12 Q Can they cause urinary problems and 13 bladder problems? 14 A Potentially I guess. 15 Q If they involve the bladder? 16 A I wouldn't say it can cause stress 17 urinary incontinence or detrusor instability, such 18 things like that. But could it cause bladder 19 tenderness or something like that, yes. 20 Q Okay. Can it cause urinary frequency, 21 overactive bladder? 22 A It can cause urinary frequency 23 potentially, yes. 24 Q In your operative note on the first 25 page of it where you discuss the indications, you Page 37 1 noted that Ms. Suter has a -- does have a history 2 of fibromyalgia. 3 A Yes. 4 Q What is fibromyalgia? 5 A It's a chronic pain syndrome that has 6 to do with diffuse pain. 7 Q And so what was the significance of her 8 history of fibromyalgia? 9 A I knew that she would have chronic pain 10 in general. 11 Q Okay. And that was consistent with 12 some of the presentation that she was having when 13 she saw you? 14 A Well, I mean fibromyalgia is usually 15 dealing more with muscles, and it's usually 16 diffuse pain throughout the body. 17 Q Okay. 18 A I don't diagnose fibromyalgia or treat 19 it so... 20 Q Okay. You also indicate that she has a 21 history of depression? 22 A Uh-huh (affirmative). 23 Q Is that significant in terms of your -- 24 either your diagnosis or treatment of her? 25 A No. Case 2:12-cv-01712 Document 51-3 Filed 07/08/16 Page 5 of 12 PageID #: 345 Danielle M. Mann, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 11 (Pages 38 to 41) Page 38 1 Q Okay. And you also noted, as we've 2 already discussed, that she had prior operations 3 of two C-sections and a total abdominal 4 hysterectomy, and you also note that she's had 5 back surgery. Is that significant at all in your 6 diagnosis of her pain? 7 A No. 8 Q Okay. And you note that she is a 9 smoker. Is that significant in terms of your 10 treatment of her? 11 A No. I would say the only thing that 12 with the smoking -- because she has a simple cyst, 13 any time I'm thinking about treating a cyst, if I 14 truly think that that's somebody's pain, then a 15 lot of times we'll treat people with birth control 16 pills to help with ovarian cysts -- and so when I 17 write that, it's a buzz word for me that this 18 woman is not a candidate for birth control 19 pills -- 20 Q Okay. 21 A -- because she's over the age of 35 and 22 she smokes. 23 Q Okay. And that increases risk -- 24 A Risk of DVTs. 25 Q Okay. You mentioned -- you used the Page 39 1 phrase earlier takedown. Can you explain for the 2 jury what that means because it's also referenced 3 in your -- your operative note that -- 4 A Like the omentum adhesions were taken 5 down? 6 Q Yes, that you began to take down -- 7 taking down of them. 8 A Okay. So I'm noting that her -- I 9 said, "The camera was inserted. And upon 10 inserting the camera, it was immediately noted 11 that there were a significant number of omental 12 adhesions to anterior abdominal wall." 13 The omentum should not be on the 14 anterior abdominal wall. It's basically stuck. 15 The omentum should be free flowing, and basically 16 that's the fatty layer that should be overlying 17 the bowel. 18 So if it's stuck to the anterior 19 abdominal wall, then to takedown, I'm literally 20 taking them down from the anterior abdominal wall, 21 and putting them back where they belong. 22 Q So you're separating something that's 23 stuck together? 24 A Uh-huh (affirmative). 25 Q Okay. And then there's also the Page 40 1 terminology, I can't find it at this moment, but 2 the lysis of the adhesions? 3 A Same thing. 4 Q What does that refer to? 5 A Same thing. So basically when two 6 things are stuck together, separating them. So 7 I'm taking down. I'm taking down from the top of 8 the anterior abdominal wall and bringing it down 9 whereas where I'm saying lysis -- lysis can be the 10 same thing but lysis -- when I say lysis of 11 adhesions, it may be taking an ovary off of a 12 pelvic sidewall or taking a bladder from a uterus. 13 Q Okay. And you indicate that the 14 patient's left ovary was difficult to appreciate 15 at all secondary to abundant amount of adhesions 16 and was being occluded by the sigmoid colon. 17 A Yes. 18 Q So perhaps in more layman's terms does 19 that mean that -- 20 A I couldn't see it. 21 Q You couldn't even detect where the 22 ovary was? 23 A Un-huh (negative), without doing 24 significant bowel surgery, and I didn't want to 25 risk damaging her bowel. Especially knowing that Page 41 1 on ultrasound it was a normal ovary. 2 Q Okay. You did remove a right ovarian 3 cyst, correct? "Patient's right ovary revealed a 4 small right ovarian cyst which was ultimately 5 aspirated without difficulty." 6 A Yes, so I didn't remove it. I 7 aspirated it. 8 Q Which means... 9 A I put a hole in it and drained it. 10 Q Okay. And then you say that there was 11 no direct evidence of endometriosis although one 12 area looked to be possibly endometriosis-related. 13 I guess, first of all, what is 14 endometriosis? 15 A Endometriosis is abnormal implantation 16 of the endometrium, which is the lining of the 17 uterus, and it is different theories about how it 18 occurs, but the most popular theory is it's 19 retrograde menstruation. So when a woman has her 20 menstrual cycle, it goes backwards. Instead of 21 through the vagina it goes backwards through the 22 uterus, through the fallopian tubes and implants 23 in different areas of the abdomen. 24 And those little areas can bleed each 25 month with the menstrual cycle, and with that Case 2:12-cv-01712 Document 51-3 Filed 07/08/16 Page 6 of 12 PageID #: 346 Danielle M. Mann, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 13 (Pages 46 to 49) Page 46 1 A Uh-huh (affirmative). 2 Q And you want to give it a little time 3 to see if this is going to help her problem with 4 pain? 5 A Sure, because I wasn't sure about the 6 endometriosis. 7 Q Okay. 8 A And so I had told her -- I said, you 9 know, let's see if it gets better on its own from 10 the lysis of adhesions. Maybe that will make you 11 feel better. 12 Q Okay. And it looks like at this time 13 your plan is to re-evaluate her pain status in 14 four to six weeks, correct? 15 A Uh-huh (affirmative). 16 Q And if she's still having pain at that 17 point, you say consider Lupron? 18 A Yes. 19 Q What is Lupron? 20 A Lupron is a GNRH agonist to help shut 21 down hormones for a little while to treat 22 endometriosis if it's in existence. 23 Q Okay. So you're thinking at this point 24 is that if she is still having pain in four to six 25 weeks, then perhaps there isn't endometriosis, and Page 47 1 you would try treating that? 2 A Uh-huh (affirmative). Since she's not 3 a candidate for birth control. 4 Q Okay. And she also indicates, I think 5 the last thing in the note, was that she is 6 reporting dyspareunia -- 7 A Yes. 8 Q -- which again is painful intercourse. 9 A Yes. 10 Q So she apparently had resumed 11 intercourse post-surgery. 12 A Yes. 13 Q Okay. Would that have been consistent 14 with any discharge instructions that you gave? 15 A What, to not have sex? 16 Q I guess let me ask it a better way. 17 Would your discharge instructions have included 18 any instructions to refrain from intercourse for a 19 period of time? 20 A No. 21 Q Okay. Did Ms. Suter return to see you 22 in four to six weeks to re-evaluate her pelvic 23 pain? 24 A I don't know. Let me see. No. 25 Q When did she next return? Page 48 1 A Almost a year later. 2 Q And would that be at 003 which would be 3 a date of November 23, 2011? 4 A Yes, that's what I have. 5 Q Okay. And as you say this is almost a 6 -- well, this is about a year after the surgery 7 but almost a year after your last office visit 8 postoperative visit in December of 2010? 9 A Yes. 10 Q And the note here indicates she's 11 complaining of pelvic pain and wants to discuss 12 previous TVT. 13 A Yes. 14 Q Do you know why she wanted now to 15 discuss her previous TVT? 16 A No. I was assuming because she thought 17 it might be the cause of her pelvic pain. 18 Q Did she tell you that at this point she 19 had seen a television ad about pelvic mesh? 20 A No. 21 Q Did she tell you that she had at this 22 point retained an attorney and was planning to sue 23 Ethicon? 24 A No. 25 Q Okay. So if you could go through this Page 49 1 one with us starting with your handwriting. 2 A I said, "Patient is having nocturia 3 three to four times per night. She's having 4 urinary frequency." 5 Q And nocturia is getting up to go to the 6 bathroom at night? 7 A Yes, three to four times a night 8 urinating. 9 Q Okay. 10 A "Urinary frequency. Still with pelvic 11 pain since operative laparoscopy." 12 Q Okay. And at this point did she tell 13 you why if she's still having pelvic pain she 14 waited for a year to return -- 15 A No. 16 Q -- instead of coming back in four to 17 six weeks as you had recommended? 18 A No. On physical exam I said, "TVT mesh 19 in place. No erosions visualized. Anterior 20 vaginal bladder pain." 21 Q Okay. So you did a pelvic exam, a 22 vaginal exam, correct? 23 A Uh-huh (affirmative). 24 Q Okay. And you could tell by palpating 25 that the TVT mesh was in place? Case 2:12-cv-01712 Document 51-3 Filed 07/08/16 Page 7 of 12 PageID #: 347 Danielle M. Mann, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 14 (Pages 50 to 53) Page 50 1 A Yes. 2 Q Okay. Did you -- 3 A I mean mesh in place, no erosions, yes. 4 Q Okay. Okay. So you saw no erosion 5 through the vaginal wall of the mesh at this 6 point? 7 A Yes. 8 Q Okay. 9 A But I noticed that her -- the anterior 10 vaginal -- the anterior portion of the 11 vagina/bladder was tender. 12 Q Was tender. Okay. Okay. Go ahead. 13 A Which is why I wrote "43 year old with 14 endometriosis, pelvic pain and questionable 15 interstitial cystitis." 16 Q Okay. So at this point endometriosis 17 is still a potential for diagnosis? 18 A I'm thinking because she's a year later 19 after the scope and she's still having pain. 20 Q Okay. 21 A So I'm wondering. 22 Q Okay. And what is interstitial 23 cystitis? 24 A Interstitial cystitis is a syndrome 25 where the interior of the bladder is lacking the Page 51 1 proteoglycan layer, which is the protective layer 2 of the bladder, which helps to protect the bladder 3 from the acidic nature of the urine, so people 4 tend to present with painful intercourse, urinary 5 frequency, bladder pain. 6 And I thought she was presenting with 7 some of those symptoms now because she had the 8 dyspareunia. She has pelvic pain. Now she has 9 urinary frequency, and I noted on exam that she 10 was having a tender bladder. 11 Q Okay. Is there any specific diagnostic 12 test that can be done for interstitial cystitis? 13 A There is. There's several. I mean 14 some urologists would put in a cystoscopy, and if 15 they see -- sometimes they'll see an inflamed 16 bladder, and they'll suspect the diagnosis. 17 Sometimes we do what I did on her a PUF 18 questionnaire to indicate if there's an increased 19 risk for interstitial cystitis. 20 There's also -- you can put a little 21 bit of acid in the bladder. And if someone hurts 22 with that, then it can indicate that they are 23 lacking the proteoglycan layer. 24 Q So what is the PUF questionnaire? 25 A It's a questionnaire that could Page 52 1 indicate a suspicion of interstitial cystitis. 2 Q Okay. And I know that's in these 3 records. 4 A Yes. 5 Q It is. It looks like it's at 0002, and 6 that is something that the patient completes based 7 on what they're experiencing and their symptoms? 8 A Yes. 9 Q And it's scored and I think you 10 indicate she had a score of 21? 11 A Yes. 12 Q Is that a high score that's on the -- 13 indicative of IC5? 14 A I believe so, yes. 15 Q Okay. 16 A I don't have my chart with me. I don't 17 remember. 18 Q Your score? 19 A Yes, but I believe so. 20 Q Okay. So that also tends to support 21 the notion that she might have interstitial 22 cystitis? 23 A I was suspicious for it, and so I 24 discussed dietary changes with her. That's 25 usually the first thing that I will do with Page 53 1 somebody that I suspect may have some interstitial 2 cystitis. 3 Q And what types of dietary changes do 4 you recommend? 5 A There is a whole host of different 6 things, but to just name a few, it's basically 7 sticking with a low acid diet. 8 Q So going on with your note from this 9 visit, and you've got your gynecological 10 maintenance. But then your second part of the 11 assessment and plan, if you could read that for 12 us. 13 A "Pelvic pain. Etiology presumed 14 endometriosis, question mark. Prescription for 15 Micronor since patient smokes. Questionable 16 interstitial cystitis. PUF questionnaire 21. 17 Discussed dietary changes." 18 Q Okay. And what is Micronor? 19 A Micronor is norethindrone. It's a 20 progesterone only birth control that she could 21 take because she smokes. She can't take estrogen. 22 Q So that would be to address the 23 endometriosis? 24 A Uh-huh (affirmative). 25 Q Okay. And you recommend a follow-up in Case 2:12-cv-01712 Document 51-3 Filed 07/08/16 Page 8 of 12 PageID #: 348 Danielle M. Mann, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 15 (Pages 54 to 57) Page 54 1 two months? 2 A Yes. 3 Q Okay. What is the next visit that 4 you -- 5 A March 21st, 2013. 6 Q So it looks like there was an 7 indication that she had an appointment, this would 8 have been her two month appointment in January -- 9 for January 25, 2012 -- 10 A Yes. 11 Q -- but did not show for that? 12 A We wrote no-show, yes. 13 Q Okay. It looks like someone indicated 14 that a message was left with her husband when she 15 did not appear for that appointment but -- and 16 that would be at -- 17 A All it says is, "No-show for two month 18 gynecological appointment. Called and left 19 message with husband." 20 Q Okay. And there was no indication 21 there that that call was returned, correct? 22 A No indication, no. 23 Q Okay. And then the next visit on 24 March 21, 2013 is Page 32 of our -- 25 A Oh, okay. Page 55 1 Q -- of our exhibit 3. 2 A All right. 3 Q So this is now again more than a year 4 after the last visit. 5 A Yes. 6 Q Okay. Which was November of 2011. 7 We're now in March of 2013. And what is her 8 complaint at this time? 9 A Complaining of bleeding for the last 10 six months. 11 Q Okay. And go ahead and read the rest 12 of that if you would. 13 A I wrote, "History of total abdominal 14 hysterectomy. States bleeding is not from the 15 rectum. Occurs PRN or occurs here and there. 16 Also complaining of pelvic pain. History of 17 operative laparoscopy with lysis of adhesions and 18 questionable endometriosis. Patient stopped 19 Micronor. History of TVT." 20 Q Okay. Do so you know why she stopped 21 the Micronor? 22 A No. 23 Q Okay. And you don't know when she 24 stopped it presumably? 25 A Huh-uh (negative), I don't know if she Page 56 1 started it -- 2 Q Okay. 3 A -- because I never saw her. 4 Q Okay. Then you did a physical, 5 correct? 6 A I did. 7 Q Okay. And what did that show? 8 A "No vaginal bleeding. No lesions in 9 the vagina. Pain of the anterior vagina and 10 bladder still." 11 Q Okay. So again at this time did you 12 see any evidence of any erosion of the mesh? 13 A No. 14 Q Okay. And although she had been 15 experiencing vaginal bleeding, you were not seeing 16 it on that occasion? 17 A No. 18 Q Okay. And what's your assessment and 19 plan? 20 A Assessment is, "Status post total 21 abdominal hysterectomy with vaginal bleeding. 22 Question mark and pelvic pain. 23 No. 1. Vaginal bleeding. No bleeding 24 today. Normal physical exam. Recommend returning 25 to office with vaginal bleeding. Page 57 1 No. 2. Pelvic pain. Questionable 2 interstitial cystitis. Patient to follow-up for a 3 PST. May need another laparoscopy. History of 4 tobacco use. No estrogen products." 5 Q Okay. So when you say recommend 6 returning to the office with vaginal bleeding, in 7 other words you'd like to see her when she's 8 actually experiencing the bleeding -- 9 A Yes. 10 Q -- so that you can -- 11 A See what's going on. 12 Q -- see what's going on. 13 Okay. And then as for the pelvic pain, 14 she is to follow-up for PST. What is a PST? 15 A That's the potassium sensitivity test. 16 That was -- I was going to do a more invasive test 17 to see if it really was interstitial cystitis by 18 putting the diluted acid into the bladder to get a 19 more definitive diagnosis. 20 Q Okay. And did she raise any problems 21 with any urinary issues or incontinence issues on 22 this occasion? 23 A No. 24 Q Okay. Did she tell you that as of this 25 date she had in fact filed a lawsuit against Case 2:12-cv-01712 Document 51-3 Filed 07/08/16 Page 9 of 12 PageID #: 349 Danielle M. Mann, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 20 (Pages 74 to 77) Page 74 1 Q Is that a potential source of her pain? 2 A Possibly. 3 Q Okay. 4 A I think there -- I was suspicious there 5 were so many reasons. I was glad she was just 6 feeling a little better. 7 Q Then you also did a physical on this 8 date, correct? 9 A Uh-huh (affirmative). 10 Q A vaginal exam. The vaginal incision 11 -- or the vaginal area where you removed the -- 12 A Is healed, uh-huh (affirmative). 13 Q -- the polyps is healing. You didn't 14 see any sign of mesh erosion? 15 A Nope. 16 Q Okay. And go ahead and read from the 17 assessment and plan there, please. 18 A "Assessment and plan. 45 year old 19 status post operative laparoscopy with right tubal 20 cystectomy and excision of redundant vaginal 21 tissue/polyps. Path benign. Abundant adhesions. 22 If BSO ever needed, patient would need bowel prep 23 and general surgery to assist because of a high 24 risk of bowel injury. Follow-up is needed." 25 Q So you don't -- you didn't have any Page 75 1 particular plans to see her. Just she was to see 2 you if she had any problems, correct? 3 A Uh-huh (affirmative). 4 Q Okay. And then the next visit was 5 maybe ten months later on March 20th of 2014. And 6 that is Page 28. 7 A Okay. 8 Q And at this time she is having vaginal 9 bleeding again, correct? 10 A Uh-huh (affirmative). 11 Q And go ahead and read starting with 12 patient well-known to me, please. 13 A "Patient well-known to me. She had 14 vaginal bleeding in the past where small polypoid 15 tissue was removed. Additionally diagnostic 16 laparoscopy for pelvic pain revealed very adherent 17 ovaries to pelvic sidewalls. 18 Patient with complaints of vaginal 19 bleeding. Painful intercourse and pelvic pain 20 again." 21 Q Okay. And then did you do an exam? 22 A Yes. 23 Q Okay. 24 A Objective on physical exam. "Area 25 under urethra extremely tender. Mesh erosion Page 76 1 appreciated with defect in vaginal tissue and 2 palpation of mesh. Smooth vaginal cuff. Right 3 and left pelvic pain." 4 Q Okay. So this is the first occasion on 5 which you had noted any mesh erosion, correct? 6 A Yes. 7 Q Okay. And your assessment and plan? 8 A "Assessment. 46 year old with mesh 9 erosion from TVT and pelvic pain. No. 1. Mesh 10 erosion. Will send to urogynecology to evaluate 11 and treat. 12 No. 2. Pelvic pain. Checked 13 transvaginal ultrasound. Patient requesting 14 BSO. In the past discussed again surgical 15 risk especially with bowel injury and ureteral 16 injury." 17 Q And you said check transvaginal 18 ultrasound. Does that mean you were going to have 19 one done? 20 A Uh-huh (affirmative). 21 Q Okay. And did you? 22 A No, it doesn't look like it was done. 23 Q Okay. Okay. So at this point did you 24 think that her complaints of pelvic pain were a 25 continuation of the complaints she's had before? Page 77 1 In other words, related to her adhesions? 2 A I was suspicious. Pelvic pain is a 3 tough thing to diagnose so... 4 Q Okay. Did you have any -- have you 5 seen her since this visit -- 6 A I have not. 7 Q -- on March 20th of 2014? 8 A No. 9 Q Okay. At this point, Doctor, having 10 done the operative laparoscopy in 2010 and 2013 11 and found the extensive pelvic adhesions, do 12 you -- do you think within a reasonable degree of 13 medical probability that those adhesions were the 14 cause of her chronic pelvic pain? 15 A Yes. 16 Q Do you think within a reasonable degree 17 of medical probability that the extensive pelvic 18 adhesions were the cause of her dyspareunia? 19 A I don't know. 20 Q Do you think -- do you believe that the 21 TVT that she received in 2008 was a factor in 22 causing her chronic pelvic pain? 23 A I have no idea. 24 Q Okay. You didn't see any signs of 25 erosion of the TVT or any other problem with it Case 2:12-cv-01712 Document 51-3 Filed 07/08/16 Page 10 of 12 PageID #: 350 Danielle M. Mann, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 22 (Pages 82 to 85) Page 82 1 Q But would you rule it out? 2 A No, I couldn't rule it out. But as I 3 said, I don't know enough about fibromyalgia. 4 Q Okay. In your experience, Dr. Mann, 5 can psychological issues contribute to a woman's 6 complaints of pelvic pain and dyspareunia? 7 A Yes. 8 MR. SAUNDERS: Object to the form. 9 Q Ms. Suter testified in her deposition 10 that she was abused by a stepfather from the time 11 she was seven until she was 13, physically 12 sexually and emotionally. 13 She testified that she was hospitalized 14 for psychological issues in the 1990s for a total 15 period of over three months, and that she has been 16 qualified for Social Security Disability since 17 2003 for depression and posttraumatic stress 18 disorder related to the abuse. 19 In your opinion, Doctor, can a history 20 such as that contribute to her complaints of 21 chronic pelvic pain and dyspareunia? 22 MR. SAUNDERS: Object to the form. 23 A Yes. 24 MS. WETTLE: I want to go off the 25 record and just take a minute to look at my Page 83 1 notes. I may be very close to being 2 finished. 3 MR. SAUNDERS: Okay. That's fine. You 4 want to take five minutes? 5 MS. WETTLE: Okay. Sounds good. 6 MR. SAUNDERS: Okay. Thanks. 7 THE VIDEOGRAPHER: We are now going off 8 record, and the time is 1:50. 9 (Thereupon, a break was taken.) 10 THE VIDEOGRAPHER: We are now back on 11 record and the time is 1:59. 12 BY MS. WETTLE: 13 Q Dr. Mann, just a couple more questions. 14 Did you at any time see any evidence 15 that the TVT sling in Ms. Suter had degraded while 16 it was in place? 17 A No. 18 Q Did you see any indication that the TVT 19 sling had frayed or shed particles while it was in 20 place? 21 A No. 22 Q Did you see any indication that the TVT 23 sling had contracted or shrunk while in place? 24 A No. 25 MS. WETTLE: Okay. That's all I have. Page 84 1 Thank you. 2 THE WITNESS: Thank you. 3 CROSS-EXAMINATION 4 BY MR. SAUNDERS: 5 Q Doctor, this is Joe Saunders as you 6 know. I'm Carol Suter's lawyer, and I'm going to 7 be asking you a few questions. 8 And as you know this case is about a 9 claim against the manufacturer of the TVT, so I'm 10 going to ask you some questions about your 11 observations. 12 In your testimony earlier you testified 13 I believe that you identified an erosion of the 14 TVT in Carol's vagina? 15 A Yes. 16 Q And what was the date that you 17 identified that erosion? 18 A March 20th, 2014. 19 Q And can you -- I understand that you 20 were trained to use a TVT in your residency but 21 you no longer use them? 22 A Yes. 23 Q Can you tell us what an erosion 24 is? 25 A An erosion is when the mesh erodes Page 85 1 through the vaginal wall and becomes exposed. 2 Q And you observed that to be the 3 case in Carol Suter when you examined her in 4 2014? 5 A Yes. 6 Q And what is her TVT made of? Do you 7 know what it's made of? 8 A No. I think I did at one time, but I 9 don't remember. 10 Q Sure. And what was your recommended 11 course of action or your plan once you saw an 12 erosion? 13 A I always send them to a urogynecologist 14 who specializes in TVT erosions. 15 Q And is treating a TVT erosion a 16 specialized procedure? 17 A In my opinion, yes. 18 Q And is that why you referred her to 19 Dr. Azadi? 20 A Yes. 21 Q Was -- is a TVT erosion painful for a 22 patient? 23 MS. WETTLE: Object to the form. 24 A Yes, it tends to be. 25 Q And did -- can a TVT erosion cause Case 2:12-cv-01712 Document 51-3 Filed 07/08/16 Page 11 of 12 PageID #: 351 Danielle M. Mann, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 24 (Pages 90 to 93) Page 90 1 granulated or was that just something that you 2 thought it could be case? 3 A It just could be. I -- I didn't think 4 it -- it didn't look like granulation tissue. 5 Q Okay. 6 A Granulation tissue is a very specific 7 look. The only thing that looked like granulation 8 tissue is the fact it was still friable. 9 Q Okay. So you don't know for a fact 10 that it even was granulated? 11 A I don't. 12 Q Okay. And then with respect to the 13 questions about why you don't use TVT, you said 14 you're not comfortable with it. And is my 15 understanding correct that you're not comfortable 16 because you have not practiced that particular 17 procedure, and you just feel others are in a 18 better position to do that? 19 A Yes. I think if you're going to 20 operate on someone, you should really know what 21 you're doing. 22 Q Okay. Am I correct that you're 23 not uncomfortable with the idea of this 24 procedure? 25 A No. Page 91 1 Q Okay. And in fact your partners do 2 this procedure? 3 A Yes, I refer the patients to them. 4 Q And do you think it is a useful 5 treatment for women who have stress urinary 6 incontinence? 7 A I do. 8 Q Okay. Have you seen, at least in the 9 overall practice of Tri-County, that patients have 10 been -- gotten good results with TVTs? 11 A I have. 12 MR. SAUNDERS: Object to the form. 13 MS. WETTLE: That's all I have. Thank 14 you. 15 MR. SAUNDERS: I don't have any further 16 questions. Thank you very much, Doctor. We 17 really appreciate you coming down. 18 THE WITNESS: No problem. Thanks so 19 much, appreciate it. 20 MS. WETTLE: Thanks, Joe. 21 MR. SAUNDERS: Bye, bye. 22 THE VIDEOGRAPHER: This concludes the 23 deposition of Dr. Danielle Mann. We are now 24 currently going off record. The time is 25 2:09. Page 92 1 * * * * * * * * * * 2 THEREUPON, the deposition 3 concluded at 2:09 p.m. 4 * * * * * * * * * * 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 93 1 STATE OF KENTUCKY ) 2 ) 3 COUNTY OF MONTGOMERY ) 4 5 I, JANINE N. LEROUX, Court Reporter, the 6 undersigned Notary Public in and for the State of Kentucky at Large, certify that the facts stated in 7 the caption hereto are true; that at the time and 8 place stated in said caption, the witness named in 9 the caption hereto personally appeared before me, and 10 that after being by me duly sworn, was examined by counsel for the parties; that said testimony was 11 taken by me in stenotype and later reduced to 12 computer-aided transcription, and the foregoing is a 13 true record of the testimony given by said witness. 14 15 No party to said action nor counsel for said parties requested in writing that said 16 deposition be signed by the testifying witness. 17 18 My commission expires: January 21, 2020. 19 20 21 __________________________________ 22 JANINE LEROUX - COURT REPORTER 23 NOTARY PUBLIC - SPECIAL COMMISSION 24 STATE-AT-LARGE 25 Case 2:12-cv-01712 Document 51-3 Filed 07/08/16 Page 12 of 12 PageID #: 352 EXHIBIT D Case 2:12-cv-01712 Document 51-4 Filed 07/08/16 Page 1 of 6 PageID #: 353 Ali Azadi, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS Page 1 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF WEST VIRGINIA AT CHARLESTON IN RE: ETHICON, INC., Master File No. 2:12-MD-02327 PELVIC REPAIR SYSTEM MDL 2327 PRODUCTS LIABILITY LITIGATION JOSEPH R. GOODWIN U.S. DISTRICT JUDGE __________________________________________________ CAROL & TROY SUTER, Plaintiffs, Case No. 2:12-cv-01712 v. ETHICON, INC. ET AL., Defendants. ____________________________________________________ WITNESS: ALI AZADI, M.D. ____________________________________________________ The video deposition of Ali Azadi, M.D. was taken before Janine N. Leroux, Stenographic Court Reporter and Notary Public - in and for the State of Kentucky at Large, at 4123 Dutchman's Lane, Louisville, Kentucky on Thursday, May 19, 2016, commencing at the approximate hour of 4:50 p.m. Said deposition was taken pursuant to Notice. Case 2:12-cv-01712 Document 51-4 Filed 07/08/16 Page 2 of 6 PageID #: 354 Ali Azadi, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 7 (Pages 22 to 25) Page 22 1 most suggestive. 2 Q Other than that finding, Doctor, was 3 the cystoscope, the cystoscopy normal? 4 A There was no other findings that would 5 suggest any other pathologies. 6 Q Okay. And you said I believe no -- no 7 sign of erosion of the mesh into the bladder or 8 the urethra, correct? 9 A Not at that point when I did the 10 cystoscopy I did not notice any mesh in the 11 bladder or urethra. 12 Q Okay. The next visit I saw was on 13 April 21st, which starts on Page 14. 14 A Sure. 15 Q And the actual -- the narrative of the 16 visit is actually on Page 15, it looks like, and 17 it indicates that Mrs. Suter was there for 18 counseling about her surgical options? 19 A That seems to be true, yes. 20 Q Okay. And you talked with her about 21 removing the -- the mesh that was exposed in the 22 vaginal cavity, correct? 23 A Correct. 24 Q And this entry indicates that you 25 discussed the risks of the procedure with her, Page 23 1 correct? 2 A Correct. 3 Q Can you go through from this note the 4 risks that you discussed with her? 5 A Well, these are the risks that are 6 explained in this note. It may not again reflect 7 the whole conversation that I had with the 8 patient, but I can read the consent for you. 9 Q Yes, if you would, Doctor. 10 A Sure. "Patient is here for surgical 11 counseling. The risk and benefits of excision of 12 mesh was discussed with the patient. She is aware 13 of the risks. We discussed that the entire mesh 14 will not be removed. 15 In addition to the risks associated 16 with any surgery including, bleeding, infection, 17 DVT, PE, and risks associated with general 18 anesthesia, the risks specific to this procedure 19 including but not limited to injury to the 20 bladder, urethra, ureters, rectum, bowels, major 21 vessels, discussed. 22 If injury happens, she may need to have 23 laparotomy, laparoscopy, prolonged catheterization 24 or colostomy. She's aware that nerve injury may 25 occur. We specifically discussed in depth the Page 24 1 pain may persist or even worsen after surgery. 2 We also discussed that prolapse may 3 return and incontinence may get worse, and she may 4 need future surgeries to treat prolapse and 5 incontinence. 6 We spent 45 minutes counseling. The 7 patient voiced proper understanding. It's all 8 right to proceed with the surgery." 9 Q Okay. That's fine. Thank you, Doctor. 10 One of the things that you mentioned is that you 11 discussed that prolapse may return. Did 12 Mrs. Suter have a bladder prolapse condition? 13 A Not -- not to my knowledge but every 14 time you do the dissection for the -- to remove 15 the mesh, I always explain that prolapse could be 16 a risk. 17 Q Okay. Okay. The word return I think 18 is what -- what confused me, but so that might be 19 a risk that she would have prolapse following the 20 surgery. Is that what you were talking to her 21 about? 22 A Right, I just wanted to mention to her 23 that prolapse is a possibility after surgery. 24 Q Okay. And then on the following page, 25 Doctor, under your assessment and plan, there's a Page 25 1 note that you plan to schedule for excision of the 2 mesh and it says, "Unable to obtain the report of 3 operation despite multiple attempts." 4 Do you know which record you were 5 trying to obtain? 6 A Mainly the report of operation for her 7 sling surgery. 8 Q For the sling surgery. Okay. Okay. 9 And at this point do you know whether you had 10 Dr. Mann's records of the two laparoscopic 11 procedures that she had done to address 12 Mrs. Suter's pelvic adhesions? 13 A Yeah, I cannot recall that at this 14 moment, but I know that I was particularly 15 interested in the mesh surgery. 16 Q Okay. Do you know if you got that at 17 some point, that record from Dr. Patterson? 18 A I can't recall, but I have to go 19 through the entire chart to look for it. 20 Q Okay. And then the next event I 21 believe was the actual surgery on May 15 of 2014. 22 And for that, Doctor, we're going to have to 23 switch to Exhibit 5 because I think the operative 24 notes are in a separate set. 25 A Sure. Case 2:12-cv-01712 Document 51-4 Filed 07/08/16 Page 3 of 6 PageID #: 355 Ali Azadi, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 8 (Pages 26 to 29) Page 26 1 Q And it is -- it starts I believe at 2 Page 18 of Exhibit 5, and actually I guess most of 3 the description is on Page 19 of Exhibit 5. 4 And you removed a portion of the mesh. 5 I believe you said you did not remove the entire 6 sling, correct? 7 A Correct. 8 Q And did you remove the portion that was 9 exposed through the vaginal wall? 10 A I -- if you don't mind, I'm going to 11 read that part of my -- 12 Q Sure. 13 A I think I removed the vaginal portion 14 of the mesh with some kind of -- not just the 15 exposed part, just the vaginal -- the vaginal 16 portion of the mesh. 17 Q Okay. And the portion that you -- that 18 you removed it indicates you sent to pathology, 19 correct? 20 A Yes. 21 Q And then before -- before you completed 22 the procedure, you did a cystourethroscope? 23 A Yes. 24 Q And tell me what that is. 25 A At cystourethroscopy is just looking -- Page 27 1 pretty much known as a cystoscopy, you know, 2 looking inside the bladder. 3 Q Okay. And is the purpose of that just 4 to make sure that there has not been injury to the 5 bladder? 6 A Injury, yes, by removing the mesh. 7 That's correct. 8 Q Okay. And your note indicates that the 9 bladder and urethra appear to be intact, correct? 10 A Yes. 11 Q So there had not been injury? 12 A Yes. 13 Q And good flow noted from the urethral 14 orifices? 15 A Correct. 16 Q So the ureters were not -- were 17 functioning properly, correct? 18 A Right. If you saw the flow, that means 19 that there was minimal chance that there was any 20 injury to the ureters by -- by my procedure. 21 Q Okay. And then you -- you sutured the 22 area in the vaginal wall where the mesh had been 23 exposed, correct? 24 A That's correct. 25 Q Okay. And then if you'll move over to Page 28 1 Page 22, Doctor, I think that's the pathology 2 report from Norton Hospital, and it gives a 3 description of what was received by pathology and 4 it says, "The specimen is submitted for growths 5 only -- 6 A Right. 7 Q -- and taken to risk management." 8 What does it mean to be submitted for 9 growths only? 10 A Well, it's -- a lot of time when we 11 remove an implant or mesh, we just don't need a, 12 you know, evaluation of cells or any kind of 13 search for any cancer or anything like that. It's 14 just basically to identify the specimen that was 15 removed. 16 Q Okay. Okay. I want to move, Doctor, 17 to the next visit, which is going to take us back 18 to Exhibit 4, which is where the office visits 19 are. 20 And I believe the next one is -- was on 21 June 2nd of 2014 and that would be at Page 32 -- 22 it starts at Page 32 of Exhibit 4, and it looks 23 like this would have been approximately two weeks, 24 maybe a little bit more than two weeks, following 25 the surgery, correct? Page 29 1 A That's correct. 2 Q And if you look on page -- I guess the 3 narrative is on Page 34. It indicates that 4 Mrs. Suter had no complaints, and that she is 5 voiding without difficulty. 6 And then it says, "Irritative voiding 7 symptoms and incontinence as mentioned in the 8 initial consult." What do you mean by irritative 9 voiding symptoms? 10 A It's a term that is commonly used to 11 describe urgency, frequency, dysuria, pain with 12 urination. 13 Q Okay. And it says no VB. Is that 14 vaginal bleeding? 15 A That's correct. 16 Q And no discharge. And are the -- it 17 mentions the sutures, that she had had one suture 18 hanging and her husband had cut it. 19 And then I think later under physical 20 exam it indicates that some sutures were trimmed 21 at this visit. So were her sutures something that 22 you would have to go back in and remove or were 23 they absorbable? 24 A Yes, these are absorbable sutures to 25 close the incision. They -- they can have Case 2:12-cv-01712 Document 51-4 Filed 07/08/16 Page 4 of 6 PageID #: 356 Ali Azadi, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 14 (Pages 50 to 53) Page 50 1 that would only be to treat her stress urinary 2 incontinence? 3 A Correct. 4 Q This is not something that would -- 5 that would treat her overactive bladder symptoms, 6 correct? 7 A Correct. 8 Q Okay. And it says you believe she 9 would benefit from the sacral neuromodulation, but 10 that's something she's elected not to do, correct? 11 A That's true. 12 Q Okay. She did elect to go forward with 13 the Burch procedure, correct? 14 A Yes. 15 Q And it looks like that was done on 16 October 21st of 2014. And again we're going to 17 have to go back to Exhibit 5. 18 A I learn. I'm starting to learn the 19 system. 20 Q And it starts I believe on Page 74. 21 Could you just describe, to the extent you can, 22 Doctor, in more or less layman's terms, what 23 procedure you did on Mrs. Suter on this occasion. 24 A The Burch colposuspension is one of the 25 procedures that is used for treatment of stress Page 51 1 incontinence and stabilizes the urethra and 2 bladder neck by suturing the periurethral tissue 3 to the Cooper's ligament on the pelvic sidewall. 4 Q And you did this procedure 5 laparoscopically, correct? 6 A Yes, that's correct. 7 Q And so that means that you made small 8 incisions? 9 A In the abdomen and placed trocars and 10 performed the procedure in a minimally invasive 11 way so... 12 Q Okay. You note in here a couple places 13 in the findings and complications that actually 14 started on the bottom of Page 74 and moved to the 15 top of Page 75 you indicate dense adhesions in the 16 retropubic area? 17 A Correct. 18 Q Did that complicate your ability to do 19 the procedure at all? 20 A Well, it -- in those cases that they 21 had prior surgery in that area, it makes the 22 surgery a little bit challenging. But I didn't 23 mention it, and I didn't think that it was a 24 complication. 25 So, you know, we were able to perform Page 52 1 the procedure without -- without any 2 complications. 3 Q Okay. And that -- toward the end of 4 the operative note right above the word specimens 5 you say, "Please note the dissection of the 6 Retzius space was very difficult due to severe 7 adhesions from prior sling surgery." 8 Were you aware at this point that she 9 had the -- at least two -- or she had had two 10 procedures by Dr. Mann to take down adhesions 11 throughout the pelvic area? 12 A I can't say for sure that at that time, 13 you know, I knew about those adhesions. I may 14 have. I don't know. I'll have to look at my 15 records that I have. 16 But the Retzius space is a potential 17 space, and usually GYN doctors don't get to that 18 space. So I think that space was an intact space 19 even though she had multiple adhesions in the 20 abdomen, but the Retzius space is usually not open 21 unless you want to do a procedure there so... 22 Q Okay. Where is the Retzius space? 23 A It's a space between the anterior 24 surface of the bladder and the anterior abdominal 25 wall. Page 53 1 Q And you indicate that they were 2 adhesions from the prior sling surgery. Is 3 that -- was that an assumption that you made, or 4 do you have a certainty that those adhesions were 5 from that prior sling surgery? 6 A Well, since she did not have any other 7 reason to have those adhesions, scar tissue, and 8 the only thing that I was aware of was the sling, 9 that's where the assumption came from. 10 In a normal person without any other 11 risk factor, having the retropubic sling or, you 12 know, a sling in that -- in that area, it's a very 13 common reason for people to have scar tissue in 14 that area. 15 Q Do you know whether Mrs. Suter had 16 other possible risk factors for scarring or 17 adhesions in that area? 18 A Not that I recall, but I think based on 19 what I wrote, that was my assumption. 20 Q And then -- all right. Now we have to 21 go back to Exhibit 4, Doctor, for the next office 22 visit, which looks like was on October 29th of 23 2014, which would have been just a little -- a 24 little over a week after this surgery, correct? 25 And that's -- I'm sorry. That's on Case 2:12-cv-01712 Document 51-4 Filed 07/08/16 Page 5 of 6 PageID #: 357 Ali Azadi, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 19 (Pages 70 to 73) Page 70 1 A We tend to see a lot of patients with 2 mesh problems because of the nature of our 3 practice because these problems they fall into our 4 specialty and because of their expertise and skill 5 level to take care of the vaginal problems. 6 Q So it would be fair to say that this -- 7 this particular patient and the treatment you 8 provided her is not unusual considering the 9 general nature of your practice? 10 MS. WETTLE: Object to the form. 11 A It's not a very specific question that 12 I can answer. If you make it clear, I'll be happy 13 to answer. 14 Q In the course of your practice do you 15 regularly -- are you regularly called on to remove 16 mesh? 17 A Yes. 18 MR. SAUNDERS: I don't have any further 19 questions, Doctor. Thank you very much. I 20 certainly appreciate you taking the time to 21 talk with us today. 22 THE WITNESS: Thank you very much. 23 Nice talking to you. 24 MS. WETTLE: I have no more questions, 25 Doctor. Page 71 1 THE WITNESS: Thank you so much. 2 THE VIDEOGRAPHER: This concludes the 3 deposition. The time is 6:24 p.m. 4 5 (Thereupon, the deposition 6 concluded at 6:24 p.m.) 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 72 1 STATE OF KENTUCKY ) 2 COUNTY OF MONTGOMERY ) 3 I, JANINE N. LEROUX, Court Reporter and 4 Notary Public in and for the State of Kentucky at 5 Large, certify that the facts stated in the 6 caption hereto are true; that at the time and 7 place stated in said caption the witness named in 8 the caption hereto personally appeared before me, 9 and that, after being by me duly sworn, was 10 examined by counsel for the parties; that said 11 testimony was taken in stenotype by me and later 12 reduced to computer-aided transcription and the 13 foregoing is a true record of the testimony given 14 by said witness. 15 The foregoing deposition has been 16 submitted to the witness for reading and signing. 17 18 19 20 21 22 _______________________________ 23 JANINE N. LEROUX, CCR(KY) NOTARY PUBLIC 24 MY COMMISSION EXPIRES: 1/21/2020 25 Page 73 1 - - - - - - E R R A T A 2 - - - - - - 3 4 PAGE LINE CHANGE 5 ____ ____ ____________________________ 6 REASON: ____________________________ 7 ____ ____ ____________________________ 8 REASON: ____________________________ 9 ____ ____ ____________________________ 10 REASON: ____________________________ 11 ____ ____ ____________________________ 12 REASON: ____________________________ 13 ____ ____ ____________________________ 14 REASON: ____________________________ 15 ____ ____ ____________________________ 16 REASON: ____________________________ 17 ____ ____ ____________________________ 18 REASON: ____________________________ 19 ____ ____ ____________________________ 20 REASON: ____________________________ 21 ____ ____ ____________________________ 22 REASON: ____________________________ 23 ____ ____ ____________________________ 24 REASON: ____________________________ 25 Case 2:12-cv-01712 Document 51-4 Filed 07/08/16 Page 6 of 6 PageID #: 358 EXHIBIT E Case 2:12-cv-01712 Document 51-5 Filed 07/08/16 Page 1 of 6 PageID #: 359 PRIVILEGED AND HIGHLY CONFIDENTIAL INFORMATION Patient: Carol Ann Suter Records Provider: Plaintiff Fact Sheet Records Obtained: 1211112015 232107.031.0001 - 232107.031.0025 SUTERC PFS 00001 - SUTERC PFS 00025 - - - - Records provided by: The Marker Group 13105 Northwest Fwy Houston, TX 77040 713-460-9070 PDF version generated on 12/1 1120 I 5 (NWF002) 25 pages plus cover sheet PRIVILEGED AND HIGHLY CONFIDENTIAL INFORMATION Case 2:12-cv-01712 Document 51-5 Filed 07/08/16 Page 2 of 6 PageID #: 360 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA CHARLESTON DIVISION IN RE: ETHICON, INC. PELVIC REP AIR SYSTEM PRODUCTS LIABILITY LITIGATION THIS DOCUMENT RELATES TO Civil Action No.: 2:12-cv-01712 MDLNo.2327 Carol Ann Suter N arne 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 infonnation as you can and then state that your answer is incomplete and explain why as appropriate. If you select an "I Don't Know" answer, please state all that you do know about that subject. If any information 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 infonnation 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, infinnary, medical or diagnostic laboratory, or other faci lity 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 SUTERC PFS 00001 Case 2:12-cv-01712 Document 51-5 Filed 07/08/16 Page 3 of 6 PageID #: 361 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 _ No ~ Don't Know_ If Yes: a. Provide the date you received the written andlor verbal information or instructions: NA b. Identify by name and address the person(s) who provided the infonnation or instructions: __ ~N~A~ ______________________ _ c. What information or instructions did you receive? __ ...!.N.!-'A'-!:..-________ _ d. If you have copies of the written 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)? Yes No If Yes, Identify by name and address the doctor who recommended removal and state your understanding of why the doctor recommended removal: NA 5) Have any of the Ethicon, Inc., pelvic mesh product(s) been removed, in whole or in part? Yes X No Don't Know 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 portion of it, removed? ----"-0=5/-=1-=5:....:12=-.=0-=1--'-4 ___________ _ b. Explain why you consented to have the pelvic mesh product(s), or any portion of it, removed? Mesh erosion, vaginal bleeding and 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 _ If Yes, please state name and address of the person or entity having possession of same. Steelgate, Inc., 2307 58th Avenue East, Bradenton, FL 34203 5 SUTERC PFS 00005 Case 2:12-cv-01712 Document 51-5 Filed 07/08/16 Page 4 of 6 PageID #: 362 6) Do you claim that you suffered bodily injuries as a result of the implantation of any Ethicon, Inc., pelvic mesh product(s)? Yes ~ 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). Constant vaginal pain and bleeding, recurrence of bladder incontinence, painful sex, deterioration of marriage, depression. 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 symptoms about three months after implantation. c. When did you first attribute these bodily injuries to the pelvic mesh product(s)? At the onset ofthe symptoms. 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): 05120/2010 e. Are you currently experiencing symptoms related to your claimed bodily injuries? Yes X No If Yes, please describe your current symptoms in detail Abd pain, recurrent incontinence, depression .. 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. Provider N arne and Condition Treated Approximate Dates of Address Treatment John M. Patterson, M.D., Pelvic pain; urinary 101 Medical Heights Dr., frequency/urgency; urinary OS/20/20 I 0 - 08/1712010 Suite A, Frankfurt, KY leakage, dyspareunia 40601 Bladder, vaginal, pelvic pain, 1111712010 - 03/2012014 Danielle Mann, D.O., 1023 nocturia, vaginal bleeding, 6 SUTERC PFS 00006 Case 2:12-cv-01712 Document 51-5 Filed 07/08/16 Page 5 of 6 PageID #: 363 VERIFICATION I, Carol Ann Suter , declare under penalty of perjury subject to all applicable laws, that I have carefully reviewed the final copy of this Plaintiff Fact Sheet dated -U-=L: . .L)_. and verified that all of the infonnation provided is true and correct to the best of my knowledge, infonnation and belief. t~Yi--~) -__ Signature of Plaintiff VERIFICATION OF LOSS OF CONSORTIUM I, Troy W_ Suter , declare under penalty of perjury subject to all applicable laws, that I have carefully reviewed the final copy of this Plaintiff Fact Sheet dated 12 -L-=-,"~ -and verified that all of the infonnation provided is true and correct to the best of my knowledge, infonnation and belief. 24 SUTERC PFS 00024 Case 2:12-cv-01712 Document 51-5 Filed 07/08/16 Page 6 of 6 PageID #: 364 EXHIBIT F Case 2:12-cv-01712 Document 51-6 Filed 07/08/16 Page 1 of 4 PageID #: 365 Medical Devices FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence Issued’ October 20, 2008 Dear Hea lthca re Practition er: This is to alert you to complications associated with transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SU:[). Although rare, these complications can have serious consequences. Following Is Information. regarding the adverse events that have been reported to the FDA and recommendations to reduce the risks. Nature of the Problem Over the past three years, FDA has received over 1,000 reports from nine surgical. mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SU]:. These mesh devlces are usually pla.ced transvaginal;y utilizing tools for m]nimally lnvasive placement. The most frequent complications included erosionthrough vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence.. There were also reports of bowel, bladder~, and bloed vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease In patient quality of life due to discomfort and pain, including dyspareunia. Treatment of the various types of complications included additional surgical procedures (some of them to remove the mesh), IV therapy, blood transfusions, and drainage of hematomas or abscesses. Specific characteristics of patients at increased risk for complications have not been determiaed. Contributing factors.may include the overall health of the patlent, the mesh material, the size and shape of the mesh, the surglcal technique used, concomitant procedures undertaken (e.g. hysterectomy), and possibly estrogen status. Reoommencla~ions Case 2:12-cv-01712 Document 51-6 Filed 07/08/16 Page 2 of 4 PageID #: 366 Physicians should; ¯ Obtain specialized training for each mesh placement technique, and be aware of its risks. ¯ Be vigilant for potential adverse events from the mesh, especially erosion and infection. ¯ Watch for complications associated with the tools used in tFanSVaginal placement, especially bowel, bladder and blood vessel perforations. ¯ Inform patients that implantation of surgical mesh is permanent, andthat some complications associat#d with the implanted mesh may require additional surcjery that may or may not correct the complication. ¯ Inform patients about the potential for serious complications and their effect on quality of life, Including pain during sexual intercourse, scarring, and narrowing of the vaginal walt (in POP repair}. ¯ Provide patients wlth a written copy of the patient labeling from the surgical mesh manufactuTer, if available.. Additiona! patient information can be found on the following FDA Consumer website. Repo~tin~q Adverse Evenl~ to FDA FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of surgical mesh, you should follow the reporting procedure established by your fadl~ty~ we also encourage you to report adverse evenLs related to surg{cal mesh that do not meet the requirements for mandato~ reporting. You can report directly to HedWatch, the FDA Safety Information and Adverse Event Reoorting program ~ by phone at :[-800-FDA-1088, or obtain the flllable Form online, print it out. and fax to 1-800-FDA-0178 or mail to HedWatch, 5600 Rshers Lane, RockviIle, HD 20852-9787. Geffing More Information If you have questions about this notification, please contact the Office of Surveillance and Biometrics (HFZ-SzID), :£350 Piccard Drive, Rockville, Maryland, 20850, Fax at 240-275-3356, or by e-mail at #hann@cdrh.fda.gov. You may also leave a voice ma]l message at 240-276-3357 and we will return your call as soon as possible. FDA medical device _Public Health Notifications are available on the Internet. You can also be notified through e-mail each time a new Public Health Not]f3cation is added to our web page. To subscribe to this service, visit: Case 2:12-cv-01712 Document 51-6 Filed 07/08/16 Page 3 of 4 PageID #: 367 h~t#://service.cLovdelivery.comiservfceisub.scribe html~code=USFDA 39 Sincerely, Daniel G. Schultz, MD Director Center for Devices and Radfological Health Food and Drug Administration Related Links ¯ Informatition on Sur.gical Mesh Case 2:12-cv-01712 Document 51-6 Filed 07/08/16 Page 4 of 4 PageID #: 368 EXHIBIT G Case 2:12-cv-01712 Document 51-7 Filed 07/08/16 Page 1 of 3 PageID #: 369 Mesh sling procedures are currently the most common type of surgery performed to correct SUI. Based on industry estimates, there were approximately 250,000 of these procedures performed in 2010. While all surgeries for SUI carry some risks, it is important for you to understand the unique risks and benefits for surgical mesh slings used in SUI repair. In order to better understand the use of surgical mesh slings for SUI and evaluate their safety and effectiveness, the FDA held a panel meeting of scientific experts (Obstetrics and Gynecology Devices Panel of the Medical Device Advisory Committee) in September 2011 and conducted a systematic review of the published scientific literature from 1996 to 2011. For surgical mesh slings used for SUI, both the panel and the FDA’s review found that:  The safety and effectiveness of multi-incision slings is well-established in clinical trials that followed patients for up to one-year. Longer follow-up data is available in the literature, but there are fewer of these long-term studies compared to studies with one-year follow-up.  The safety and effectiveness of mini-slings for female SUI have not been adequately demonstrated. Presently, it is unclear how mini-slings compare to multi-incision slings with respect to safety and effectiveness for treating SUI. Additional studies may help the agency to better understand the safety and effectiveness of these devices.  Mesh sling surgeries for SUI have been reported to be successful in approximately 70 to 80 percent of women at one year, based on women’s reports and physical exams. Similar effectiveness outcomes are reported following non-mesh SUI surgeries.  The use of mesh slings in transvaginal SUI repair introduces a risk not present in traditional non-mesh surgery for SUI repair, which is mesh erosion, also known as extrusion.  Erosion of mesh slings through the vagina is the most commonly reported mesh-specific complication from SUI surgeries with mesh. The average reported rate of mesh erosion at one year following SUI surgery with mesh is approximately 2 percent. Mesh erosion is sometimes treated successfully with vaginal cream or an office procedure where the exposed piece of mesh is cut. In some cases of mesh erosion, it may be necessary to return to the operating room to remove part or all of the mesh.  The long-term complications of surgical mesh sling repair for SUI that are reported in the literature are consistent with the adverse events reported to the FDA.  The complications associated with the use of surgical mesh slings currently on the market for SUI repair are not linked to a single brand of mesh. The FDA conducted a review of Medical Device Reports (MDRs) received from Jan. 1, 2008 through Sept. 30, 2011. During this time frame the FDA received 1,876 reports of complications associated with surgical mesh devices used to repair SUI. The most common complications reported through MDRs for surgical mesh slings for SUI repair, in descending order of frequency, include: pain, mesh erosion through the vagina (also called exposure, extrusion or protrusion), infection, urinary problems, recurrent incontinence, pain during sexual intercourse (dyspareunia), bleeding, organ perforation, neuro-muscular problems and vaginal scarring. Many of these complications require additional medical intervention, and sometimes require surgical treatment and/or hospitalization. With the exception of mesh erosion, the above complications can occur following a non-mesh surgical repair for SUI. MDRs are submitted to the FDA by medical device manufacturers, importers, health care facilities, health care professionals and patients. MDR information is used to monitor marketed medical Considerations about Surgical Mesh for SUI Medical Devices Home Medical Devices Products and Medical Procedures Implants and Prosthetics Page1 of 2Urogynecologic Surgical Mesh Implants > Considerations about Surgical Mesh for SUI 4/2/2013http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetic... Case 2:12-cv-01712 Document 51-7 Filed 07/08/16 Page 2 of 3 PageID #: 370 Page Last Updated: 03/27/2013 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website Policies U.S. Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Ph. 1-888-INFO-FDA (1-888-463-6332) Email FDA For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive devices, and contribute to the detection of potential product-related safety issues as well as the benefit-risk assessments of these products. While MDRs are a valuable source of information, this passive surveillance system has notable limitations, including the potential submission of incomplete or inaccurate data, under-reporting of events, lack of denominator data (number of implants), and the lack of report timeliness. Links on this page: Page2 of 2Urogynecologic Surgical Mesh Implants > Considerations about Surgical Mesh for SUI 4/2/2013http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetic... Case 2:12-cv-01712 Document 51-7 Filed 07/08/16 Page 3 of 3 PageID #: 371 EXHIBIT H Case 2:12-cv-01712 Document 51-8 Filed 07/08/16 Page 1 of 2 PageID #: 372 Potential Risks of Non -Mesh and Mesh SUI Surgeries NON -MESH Acute and /or Chronic Pain with Intercourse MESH Acute and /or Chronic Pain with Intercourse Acute and /or Chronic Pain Acute and /or Chronic Pain Vaginal Scarring Vaginal Scarring Infection Infection Urinary Problems (urinary frequency, urgency, dysuria, retention, or obstruction; incontinence) Urinary Problems (urinary frequency, urgency, dysuria, retention, or obstruction; incontinence) Organ / Nerve Damage Organ / Nerve Damage Bleeding Wound Complications Bleeding Wound Complications Inflammation Inflammation Fistula Formation Fistula Formation Neuromuscular Problems (in pelvic floor muscles, lower extremities, and /or abdominal area) Neuromuscular Problems (in pelvic floor muscles, lower extremities, and /or abdominal area) One or more surgeries to treat an adverse event One or more surgeries to treat an adverse event Recurrence or Failure Recurrence or Failure Foreign Body Response (sutures /grafts) Foreign Body Response (mesh) Erosion /Exposure /Extrusion (sutures /grafts) Erosion /Exposure /Extrusion (mesh) Contraction /Shrinkage of tissues Contraction /Shrinkage of tissues Case 2:12-cv-01712 Document 51-8 Filed 07/08/16 Page 2 of 2 PageID #: 373 EXHIBIT I Case 2:12-cv-01712 Document 51-9 Filed 07/08/16 Page 1 of 4 PageID #: 374 gYNECAREÇ TVT Tension -free Vaginal Tape TVT Implantat - Einwelt TVT.Einfiitmtngsinstniment - wiederverwendbar TVT- létall KatheterFiührung -,wied verwendbar rry.. * cif fiï Steh ILTVT bind til engangsbtu 1;VT,ñidictrer tii flergangsbr4 " TVII4u iewire Iii flergangsbnl Disposit'rvÇo de un solo usoi T introductoi reutilizabieTVT " Guía rigida reutilizable pare el catétarTV,T Dispositir a usage unique \ IntroductcTVT réutilisante Guide de sende rigide TV1' réutilisable l Mneulartakäyttöine tl i TVTtoistokäyttöinen sisaánviejä TVT toistokiiyttöinen jäykktä katelinohjain TVT Singlese Device TVT Reusal introducer TVT Reusatä Rigid Cath ter Guide Ëuoxsurj ptaq )(pnorlç TVf- i t Etooymytaç IVf noN,an)i ç Xprjanç ; O& iyeq rtroukai -trpaitoNarr}Tr)(pc: 1Vr . Dispositivo TVT monouP J Introduttore liuso perrdispositivoTVT ,- tda rigida pö p iíuso acatetereT 1-v instrum teti woor Omalig geb NL TVT reusable inlrtenghehdvat TVT reusable çatlietëryoerder Ll ao DisposrtivaM -_e.§o únie P Introdutor TVT - Rëúfilbável Gula rigida de cateterTVT- Reutilizávei TVT náiar med inkontinensband far engángsbtrk WE handtag tör flergängsbruk TVT kateterguide för flergángsbruk Authorized Representative Autoriseret repraasentant Erkende vertegenwowdiger Vahuutettu edustaja Représentant autorisé Autorisierter Vertreter Rappresentante autorizzato Representante autorizado Representante autorizado Auláoriserad representant Eouotoóokkpcvoç Avnnpeaonoç ErHICON® GmbH Robert- Koch -Strasse 1 0 -22851 Norderstedt Germany EC Legal Manufacturer L` ETHICON, Sàri Rue du Puits -Godet 20 CH -2000 Neuchâtel STATUS 10/04 Switzerland RMC P 15506/D 0086 CONFIDENTIAL SUBJECT TO STIPULATION AND ORDER OF CONFIDENTIALITY IBIT ETH.MESH.05222673 Case 2:12-cv-01712 Document 51-9 Filed 07/08/16 Page 2 of 4 PageID #: 375 M Single Use Device M Reusable Introducer TVT Reusable Rigid Catheter Guide Please read all Information carefully. Failure to properly follow instructions may result In improper frmc- tinning of the device and lead to injury. Important: This package insert is designed m pmvide instructions for use of the Tension -free Vaginal Tape single ace device, reusable intnduce, mumble rigid catheter guide. It is not a comprehensive reference to surgical technique for correcting SUI (Stress Urinary Incontinence). The device should be used only by physicians trained in the surgical vestment of Strew Urinary Incontinence :rod specifically in implanth ng the TVT dev ice. These inatmcdoaa are recommended forge -serail use of the device. Variations in use may tear in specific pmeedutes due to individual technique mid patient anatomy. DESCRIPTION (System) TVT comb:is of the following: TVT Single -Use Device, provided sterile (available separately) TVT Reusable Introducer, provided non -sterile (available separately) TVT Reusable Rigid Catheter Guide, provided non- sterile (avail- able separately) TVTDEVICE TheTVT device in a sterile single use device, tonnisting alone piece of undyed or blue (Phtahtcyanine blue, Colour index. Number 74160) PROtENI3 polypropylene mesh (tape) approximately 1/2 x I R inches (I. i x 45 sun), covered by a plastic sheath cut and overlap- ping in the middle, and held between two stainless steel needles bonded to the mesh end sheath with plastic collars. PROLDNE' polypropylene mesh in crnsimcled of knitted filaments of eztntded polypropylene strands identical in composition to that used in PROLENE' polypropylene nonabeorbable surgical suture. The mesh is approximately 0.027 inches (0.7nma) thick. This materi- al, when used ass at suture, has been reposed to be non -reactive and to retain its strength indefinitely in clinical use. PROLENli mesh in knitted by a process which interlinks each fiber junction and which provides for elasticity in both directions. This bi- directional elastic pmperty allows adaptation to various Strenne; encotmtered In the body. TVT INTRODUCER The TVT introducer is provided run- sterile and is mumble. The introducer is made of steiniess creel. It consists or Iwo parts, a hurdle and an inserted threaded metal shaft. The taro ducee is intended to facilitate the passive of the TVT device from the vagina to the abdominal stan. It is connected and lined to the needle, via the threaded end of the she(, prior to insening the needle with the tape. TVT RIGID CATHETER GUIDE The TVT rigid catheter guide is a non- sterile reusable instrument intended to facilitate the idmrtilìenion of the urethra and the bladder neck during the snrgleal procedure- la is inserted into a Fraley catheter (recommended size IS French) positioned in thebtadder via the ure - thra. To facilitate insertion, it can be lubricated with gel. INDICATIONS The TVT device is intendal to be used as a pnbourethml sling for treatment of stress wintry incontinence (SUI), for female urinary incontinence resulting from erethad hypermobility and/or intrinsic sphincter deficiency. TheTVT introducer and rigid catheter guide are mailable separately and intended to facilitate the placement of the TVT device. 26 INSTRUCTIONS FOR USE The patient should be placed in the lithounty position taking care to avoid hip flexion greater than lilt". The procedure con be carried out under local anesthesia but it can also be perforated using regional or general anesthesia. The extent of dissection is minimal, i.e. a vaginal midline entry with a ornati pars- urethral dissection to initially position the needle and two suprapubic skin incisions. Using forceps, grasp the vaginal wall at each ride of the urethra. Wing a small scalpel, make a sagittal inci- sion about 1.5 cm long starring approximately 1.0 cm from the outer treated mellans. This incision will cover the arid- urethral zone and will allow for subsequent passage of the; ling (tape). With a small pair of blunt scissors, two smrill parturelhrel dissections (approximately 05 em) are made so that the tip of the needle can then be intrxluced into the paraurethral dissection. Then, two abdominal skin incisions of OS -t ern are made, one on each side of the initiate just above the syanphysis not more than 4 -5 car apart. Incision placement and needle passage near the midline end close to the back of the pubic bone are important to avoid anatom- ic structures in the ingutnal area and lateral pelvic sidewall. The TVT rigid catheter guide ix inserted into the chnnnel of the Foley catheter (IS French). The handle of the guide is fixed around the catheter, proximal lo ist widening. The prpaave of the guide is to move the bladder neck mid urethra away from where the tip of the needle will pass into the retmpubic space. Via use of the Foley catheter and the rigid catheter guide, the urethra and bladder are nerved contmlatemlly to the side of the needle passage. During this maneuver, the bladder should be empty. The threaded end of the introducer is screwed into the end of one of the needles. Using the introducer, the needle is paused paraurethrally penetrat- ing the urogenita diaphragm. Insertion and passage are controlled by ruing the long or index finger in the vagina under the vagina wall on the iplateml side and fingertip control on the pelvic rim. T2>e cawed part of the needle should rest in the palm of the "vagi- nal "hand, if you ate right handed thin means that the left hand gen- coolly in the one to housed for needle guidance. With the other hand grip the handle of the introducer gently. Now introduce the needle up Into the retropnbic space. Once again observe that this should be done by the palm of the vagina] hand and with the needle tip hori- zontally i.e. in the frontal plane. After passage of the urogenital diaphragm you will feel that the resistance is significantly reduced. Jnnmedintely aim the tip of the needle towards the abdominal mid - line and lower the handle of the introducer thereby pressing the tip of the needle against the back of the pubic bone. Now, move the needle tip upwards to the abdominal skin incision, keeping in chase contact with the pubic bone all the way. When the needle tip has reached the abdominal incision, cys- toscopy in perfoned to confirm bladder integrity. The bladder nuke be emptied after the first cystonoopy. The procedure ba then repeat- ed on the other side. The needles are then pulled upward to bring the tape (cling) loosely, i.e, without tension, under the mldurethrr. Cut the tape close to the needles Now, adjust the tape so that leak- age in reduced allowing a few drops of urinary leakage to occur under stress, For this, use patient feedback i.e. coughing with a full bladder (m proximately 300nd) and keep the vaginal incision tem- porarily closed by a gentle grip with small forceps. The plastic sheathe that surround the time are then removed. To avoid putting tension on the tape, a blunt instrument (scissors or forcep) should be placed between the urethra and the tape during removal of the plastic sheaths. Premature removal of the sheath may make subse- quent adjastmens difficult. After proper adjustment of the tape, close the vaginal incision. The abdominal ends of the (ape ate then cut and left in subetaic. Do not Suture them. Suture the skin in isions. Empty the bladder. Following this procedure, pstopenuive catheter - h adon is not typically required. The patient should be encouraged to try to empty the bladder 2-.3 tours after the operation. CONTRAINDICATIONS As with any Suspension surgery, thin procedure should not be per- formed in pregnant patients. Additionally, because the PROLENC' polypropylene niece will not stretch significantly, it should not be performed in patients with future growth potential including women with plans for future pregnancy. CONFIDENTIAL SUBJECT TO STIPULATION AND ORDER OF CONFIDENTIALITY 27 ETH.MESH.052226$6 Case 2:12-cv-01712 Document 51-9 Filed 07/08/16 Page 3 of 4 PageID #: 376 WARNINGS AND PRECAUTIONS Do not use TVT procedure for patients who are on and-coagula- tion therapy. Do not use TVT pmcedure for patients who have a urinary tract infection. Users should be funniliar with surgical technique for bladder neck suspensions end should be adequately trained in implanting the TVT system before employing the Tyr device. It is important to recognize that TVT is different from a traditional sling pmce- dere in that the tape should be located without tension murder slid- urethra Acceptable surgical practice should be followed for the TVT pmcedure at well ru for the management of =laminated aminated or Infected wotmds. The TVTprocedure should be performed with care to avoid large vessels, nerves, bladder and bowel. Attention to local anatomy and proper ppauox age of needles will minimise risks. Retropubic bleeding may aceur postoperatively, °tee e for any symptoms or signs before releasing the patient frona ho rpital. Cyttoscopy should be performed to confirm bladder integrity or reeolpmize a bladder perforation. The rigid catheter guide should be gently pushed into the Foley catheter SO that the catheter guide does not extend into the holes of the Foley Catheter. When removing the r ld catheter guide, open the handle cem- pletely an that the catheter remains properly in place. Do not remove the plastic sheath until the tape has been proper- ly positioned. Enture that the tape is plated with minimal tension cedar mid- urethra. PROLENI' mesh in contaminated areas should be aged with the understanding that subsequent infection may require removal of the material. The patient should be cotmseled that future prepencies may negate the effects of the surgical procedure and the patient may again become incontinent. Since no clinical experience is available with vaginal delivery following the TVT procedure, in case of pregnancy delivery via ceeerian tection is recommended. Postoperatively the patient is recommended to refrain front heavy lifting and/or exercise Ilse. cycling, jogging) for at least three to four weeks and intercourse for one month. The patient can return to other normal activity after one or two weeks. Should dysuria, bleeding or other problems occur, the patient is instmcied to contact the surgeon immediately. All surgical instruments are subject to wear and damage tinder normal use. Before tmse, the instrument shoald be visually inspected. Defective intmanents or instruments that appear to be corroded should not be used and should be discarded. As with other incontinence pmeedures, de nano denser insta- bility may occur following the TVT procedure. To tninimira this riait, nnd:e emu to place the tape tension -free in the midnrethnrl position. Do not contact the PROLIINC' mesh with any staples, clips or clamps as mechanical damage to Ile mesh may oasis Do not resterilize TVT device. Discanl opened, amused devices. ADVERSE REACTIONS Punctures or lacerations of vessels, nerves, bladder orbowelmay occur during needle passage and may require surgical repair. Transitory local irritation at the wound site and a transitory for- eign body response may occur. This response could result in extortion, erasion, fistula Formation and inflammation. As with all fcreipt bodies. PROLENE mesh may potentiate en existing infection. The plastic sheath initially covering the PRO- LEND' mesh is designed to minimize the risk of contamination. Over correction i.e. too much tension applied to the tape, may cause temporary or permanent lower urinary tract obstmetion. 28 ACTIONS Animal studies show thaat implantation of PROLENE mesh elicits a minimal inflammatory reaction it 6 melt, which is transient and is followed by the depnsitinn of a thin fibrous layer of tissue which can grow through the interstices of the meth, thus-incorporating the mesh into adjacent timue The material is not ab orbed, nor is it srtbjen to degradation or weakening by the action of tisane enzymes. INSTRUCTIONS FOR CLEANING REUSABLE lei lSCRUMTA'TS (TVT Intrndnccr, TVT Rigid Catheter Guide) To ensure the relia- bility and functionclity of TVT Introducer and TVT Rigid Catheter Guide, clean the instruments before initial use and after each prose- dap. The following are suggested maned and automated methods for cleaning the instruments. Prior to cleating, the TVT introducer should be =penned into its component pmts (handle and threaded shaft). The Introducer is reassembled after cleaning and before ster- itization. Montral method I. Soak the irutnmrcnt compmenta in an enzyme cleaner suitable for stainless steel instruments. 2. Wash in a tragical detergent and disinfecting solution at a tem- perature of 86° F to 95' F (30" C to 35° C). Remove any con- tamination from body fluids or dames using a soft brush. 3. Place the instrument components in an ultrasonic bath with fresh detergent solution for approximately 10 minutes or follow the' insma:tions below if using an automatic washing cycle. 4. Rinse thoroughly in a stream of fresh rap wirer followed by towel drying. The instrument components may be treated with instm- ment lubricant. Automated Method: Automatic washing cycles are suitable for stainless steel insmmments. One recommended cycle is described below: RinsefWet Cycle Cold Water- 1 minute Wash 176' F (80° C)- 12 minutes Rinse Cycle- 1 minute Rinse Cycle - 12 minutes Final Rinse -2 minutes Rinne with Denvneralized water 176" F (80° C) -2 minutes Dry 199.4° F(93° C) - 10 minutes STERILIZATION RECOMMENDATIONS FOR REUSABLE INSTRUIuIENTS (FSrT Introducer, TVT Rigid Catheter Guide) The TVT Introducer, TVT Rigid Catheter Guide are supplied mm- sterile. To sterilize, steam autoclave prior to each use Steam aurto- clave at a temperature of 270° P to 254" F (132' C to 140° C) for a minimum of 4 minutes (pre- vacuum). It is the responsibility of the end tiler to atsure sterility of the product when using sterilization process recommended, since bioburden and sterilization equipment will very. INSTRUMENT MAINTENANCE TVT Introducer Before euh use inspect the threaded pans of the inner shaft. TVT Rigid Catheter Guide Before each use, inspect the instnnnent. Check to ensure that the long end which traverses the catheter channel hat no sharp edges or-burrs. HOW SUPPLIED The TVT devise ht provided sterile (ethylene oxide) for single est. Do not re- sterilize. Do not age if package is opened or cheeped. Discud opened, unused devices. The reusable TVT introducer. TVT rigid catheter guide are supplied separately, and are non- sterile These oeewcems are to be cleaned and sterilized prior to melt use as described above. 29 CONFIDENTIAL SUBJECT TO STIPULATION AND ORDER OF CONFIDENTIALITY ETH.MESH.05222687 Case 2:12-cv-01712 Document 51-9 Filed 07/08/16 Page 4 of 4 PageID #: 377 EXHIBIT J Case 2:12-cv-01712 Document 51-10 Filed 07/08/16 Page 1 of 10 PageID #: 378 Lennox Hoyte, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS Page 1 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF WEST VIRGINIA AT CHARLESTON - - - IN RE: ETHICON, INC., PELVIC Master File No. REPAIR SYSTEM PRODUCTS 2:12-MD-02327 LIABILITY LITIGATION MDL 2327 ---------------------------------- THIS DOCUMENT RELATES TO: Carol Ann Suter, et al. v. Ethicon, Inc., et al. Civil Action No. 2:12-cv-01712 - - - Thursday, June 30, 2016 - - - Deposition of LENNOX HOYTE, M.D., held at Squire Patton Boggs, One Tampa City Center, Tampa, Florida, on the above date, beginning at 9:18 a.m., before Kimberly A. Overwise, a Certified Realtime Reporter and Notary Public. - - - GOLKOW TECHNOLOGIES, INC. 877.370.3377 ph | 917.591.5672 fax deps@golkow.com Case 2:12-cv-01712 Document 51-10 Filed 07/08/16 Page 2 of 10 PageID #: 379 Lennox Hoyte, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 9 (Pages 30 to 33) Page 30 1 or laparoscopic procedure for attaching mesh 2 transabdominally to the vagina for the repair of pelvic 3 organ prolapse. 4 Q Okay. And that's not the type of procedure 5 we're talking about with Ms. Suter? 6 A That is not. 7 Q Do you know if the weight of the Ethicon TVT 8 sling is greater or less than the weight of the Desara 9 sling that you use? 10 A I recall from handling the materials that the 11 TVT was heavier and had smaller pores and was less 12 flexible, the Ethicon product. 13 Q When you say from handling it, when were you 14 handling the TVT product? 15 A Years ago when I implanted it. 16 Q So your understanding or your belief is that 17 the TVT is a heavier mesh than Desara; is that correct? 18 A That is my sense. 19 Q Your sense. And that's based on your handling 20 of TVT possibly ten years ago when you implanted perhaps 21 up to four TVT slings? 22 A That's my recollection. 23 Q And am I correct that it's also your sense 24 that the pore size of the Ethicon TVT sling is smaller 25 than the pore size of the Desara? Page 31 1 A Yes. I do recall that there were multiple 2 different pore sizes in the retropubic TVT sling. 3 Q And, again, that's your recollection from when 4 you handled TVT slings in up to four cases perhaps ten 5 years ago? 6 A That is my recollection from that, yes. 7 Q How long have you used the Desara sling? 8 A Many years, I believe six years or more. 9 Q Six or more years? Okay. Has the design of 10 the Desara changed at all over that time? 11 A Not the one that I use. It seems to be the 12 same device. 13 Q Why did you choose the Desara product? 14 A I had studied the character of the material. 15 I felt it was a softer, more flexible material. It 16 didn't seem to curl when I put it under tension. And 17 the trocar needles for placement were small so that you 18 can get two passes simultaneously and the needles were 19 rigid enough that they didn't overbend when you passed 20 them through the retropubic space. 21 Q Are there randomized controlled trials 22 regarding the use of the Desara product? 23 A I don't know that there are. 24 Q You can't point me to any that you're familiar 25 with? Page 32 1 A No. I wasn't asked to look at that so I don't 2 have any off the top of my head. 3 Q I just wondered if you knew about that from 4 your use of the product, not because of this case 5 necessarily. 6 A I can't -- none come to mind right now. 7 Q I mean, do you believe that the Desara sling 8 is a safe and effective product as a surgical implant to 9 treat stress urinary incontinence? 10 A Retropubic polypropylene sheath sling is safe 11 and effective when in the right hands with the right 12 disclosure. 13 Q Do you believe that the Desara retropubic 14 polypropylene sling has been extensively studied as an 15 anti-incontinence treatment? 16 A I believe it has. I can't quote you the 17 literature on it. 18 Q Do you believe that the use of a retropubic 19 polypropylene midurethral sling is the standard of care 20 for the surgical treatment of stress urinary 21 incontinence? 22 A Retropubic suburethral sling for the treatment 23 of stress incontinence I believe is the standard of 24 care. 25 Q Polypropylene sling? Page 33 1 A Correct. 2 Q I want to get into each of your opinions about 3 Ms. Suter in some detail, but let me just sort of recap 4 them so we all know what we're going to be covering in 5 the deposition. Okay? 6 A Sure. 7 Q I want to make sure I know what you are going 8 to say was caused by the Ethicon TVT and what you're not 9 going to say was caused by the Ethicon TVT. 10 A Okay. 11 Q Is it your opinion, Doctor, that she had an 12 erosion of mesh into the vaginal wall as a result of the 13 TVT? 14 A May we go to the part of the record that 15 points to that? 16 Q Sure. 17 A It's hard for me to remember -- 18 Q Right. 19 A -- all of that. So on page 8 of my report I 20 see that on 4/13/14 there was a statement about mesh 21 erosion given by Dr. Azadi. So, yes, that's on the 22 record. 23 Q And are you going to be giving the opinion in 24 this case that Ms. Suter is at risk of possible future 25 mesh erosion as a result of the Ethicon TVT? Case 2:12-cv-01712 Document 51-10 Filed 07/08/16 Page 3 of 10 PageID #: 380 Lennox Hoyte, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 10 (Pages 34 to 37) Page 34 1 A I believe I said that in my report. 2 Q So that is an opinion you're going to offer; 3 correct? 4 A I believe so. I've said that. 5 Q Are you going to offer the opinion that 6 Ms. Suter experienced vaginal bleeding as a result of 7 the TVT sling? 8 A Yes. 9 Q Are you going to give the opinion that 10 Ms. Suter experienced dyspareunia, or pain with 11 intercourse, as a result of the TVT sling? 12 A Yes. 13 Q Are you going to give the opinion that 14 Ms. Suter is experiencing myofascial pain due to pelvic 15 muscle spasm as a result of the TVT sling? 16 A Let me please look at -- 17 Q Please. And if you are, please point me to 18 where you say that in your report. 19 A I did diagnose her with myofascial pain and I 20 said it's amenable to cure with physical therapy. I 21 said after detailed urogyn examination she is found to 22 have myofascial pain due to pelvic muscle spasm and 23 mixed urinary incontinence. I said the prognosis for 24 myofascial pain is good. I have not said anywhere that 25 the myofascial pain was caused by the TVT, definitively Page 35 1 caused by the TVT. 2 Q Okay. So you are not going to be offering the 3 opinion at the trial of this case that Ms. Suter is 4 experiencing myofascial pain due to pelvic muscle spasm 5 as a result of the TVT sling? 6 A I didn't make that connection in my report. 7 Q Okay. And so based on everything you know 8 now -- I understand the qualification that you might get 9 additional information and might revisit your analysis. 10 A Yes. 11 Q But based on everything you've read so far, 12 you are not going to be offering the opinion -- if the 13 trial were today, you would not be offering the opinion 14 that Ms. Suter's experiencing myofascial pain due to 15 pelvic muscle spasm as a result of the TVT; correct? 16 A I can't say that. I can't offer that opinion 17 today based on what I know today. 18 Q And similarly, Doctor, I did not see anywhere 19 in your report where you are stating that Ms. Suter has 20 urinary incontinence, either stress urinary incontinence 21 or urge urinary incontinence, as a result of the TVT. 22 Could you confirm that for me, please? 23 A I asked -- I said that the urinary 24 incontinence requires further workup before prognosis 25 can be offered. So I didn't say anything about the urge Page 36 1 incontinence being related to TVT, although I know and 2 it is understood in our field that urge incontinence, de 3 novo urge incontinence, can occur after placement of 4 midurethral slings. 5 Q But you're not offering -- as of today you're 6 not offering the opinion that Ms. Suter's urge 7 incontinence is caused by the Ethicon TVT sling; is that 8 correct? 9 A Please ask the question again. 10 Q Sure. She reported to you complaints of urge 11 incontinence; correct? 12 A That is correct. 13 Q Okay. My question is, are you as of today of 14 the opinion that Ms. Suter has urge urinary incontinence 15 as a result of the placement of the Ethicon TVT sling in 16 2008? 17 A I cannot rule that out, but let me please look 18 at the record to see what her presurgical complaints 19 were. 20 I don't see a history of urge urinary 21 incontinence prior to the patient's TVT and I understand 22 and know that de novo urge incontinence can occur 23 following TVT placement so I cannot rule that out. But 24 I'm not saying that it caused it right now, but I can't 25 rule it out. Page 37 1 Q Okay. So you're not testifying today -- 2 A Today. 3 Q -- to a reasonable degree of medical 4 probability or certainty that the TVT caused her urge 5 incontinence; is that -- 6 A I'm not saying that today but I'm not ruling 7 it out either. 8 Q And you said that de novo urge incontinence is 9 a known potential risk of the placement of a retropubic 10 midurethral sling; correct? 11 A Correct. 12 Q Including the Desara sling that you use; 13 correct? 14 A Including the Desara sling that I use. 15 Q And am I correct that you are not opining that 16 she has abdominal pain as a result of the TVT sling? 17 A You are correct. 18 Q And am I correct that you are not opining that 19 she has a, quote -- and this is what she reported to 20 you -- quote, abnormal vaginal opening, unquote, as a 21 result of the TVT sling? 22 A Correct. 23 Q And you are not opining that she has 24 depression or any other mental or psychological 25 condition as a result of the TVT sling; correct? Case 2:12-cv-01712 Document 51-10 Filed 07/08/16 Page 4 of 10 PageID #: 381 Lennox Hoyte, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 11 (Pages 38 to 41) Page 38 1 A I didn't opine that today. And I noted that 2 Ms. Suter's history was notable for depression and she 3 was on Prozac and a gabapentin medication related to 4 neurological and psychiatric -- not psychiatric, excuse 5 me -- related to depression. 6 Q Before the implant? 7 A Before the implant. She had depression before 8 the implant. 9 Q So you're not going to offer the opinion that 10 Ms. Suter has any psychological injury, depression or 11 otherwise, as a result of the TVT sling; correct? 12 A I'm going to say she had depression before and 13 she had depression after, so it's hard to implicate the 14 TVT sling in that. 15 Q So what we have for your opinions is that you 16 are going to offer the opinion that she experienced mesh 17 erosion into the vaginal wall as a result of the TVT 18 sling? 19 A Correct. 20 Q That she has the risk of possible future mesh 21 erosion as a result of the TVT sling? 22 A Correct. 23 Q That she had vaginal bleeding at one time as a 24 result of the TVT sling? 25 A Correct. Page 39 1 Q And that she has dyspareunia as a result of 2 the TVT sling? 3 A Yes. 4 Q You're going to offer that opinion. Are there 5 any other conditions or symptoms that Ms. Suter has had 6 or currently has that you will opine are the result of 7 the TVT sling as of today? 8 A What I will say is I will make a connection 9 between her present myofascial pain and the fact that 10 somewhere after her TVT was placed she had an erosion 11 and vaginal pain. Vaginal pain can cause a progression 12 to myofascial pain. That's the connection I will make. 13 Q And are you going to say then that her vaginal 14 pain progressed to myofascial pain? Are you going to 15 offer that opinion to a reasonable degree of medical 16 certainty? 17 A I'm going to say it's a possibility because 18 pain anywhere in the pelvis can progress to myofascial 19 pain if not promptly treated. 20 Q So you're going to say it's a possibility, but 21 you are not going to say today based on what you've 22 reviewed that the vaginal pain progressed to myofascial 23 pain to a reasonable degree of medical probability; 24 correct? 25 A Right. Page 40 1 Q Because I did not see that in your report. 2 A That is correct. 3 Q Do you agree, Dr. Hoyte, that erosion of 4 synthetic mesh into the vaginal wall is a known risk of 5 incontinence surgery with midurethral slings? 6 A I know that from my own patients; yes. 7 Q And it's a known risk with the Desara sling 8 that you currently use with patients; correct? 9 A That is correct. 10 Q Is erosion of material into the vagina also a 11 known risk of nonmesh treatments such as cadaver grafts 12 or porcine tissue used for slings? 13 A I have not seen cadaver grafts or autologous 14 grafts erode into the vagina. 15 Q Are you aware from the literature, though, 16 that that is a risk of those procedures? 17 A I read and Dr. Horbach properly pointed out 18 that if permanent sutures are used in the vicinity of 19 the vagina, that the sutures themselves can erode but 20 not the graft itself. 21 Q But we agree that erosion of synthetic mesh, 22 polypropylene mesh, into the vaginal wall is a known 23 risk of polypropylene midurethral slings used to treat 24 stress urinary incontinence; correct? 25 A It's a known risk. Page 41 1 Q And is that a risk that you counsel your 2 patients about when you implant a Desara sling? 3 A Yes. 4 Q Is it your opinion, Dr. Hoyte, that Ms. Suter 5 experienced mesh erosion into the vaginal wall as a 6 result of a defect in the Ethicon TVT sling? 7 A No. Please ask the question again. 8 Q Sure. 9 A I want to make sure. I think I'm agreeing but 10 with you, but I want to just verify. 11 Q Is it your opinion, Dr. Hoyte, that Ms. Suter 12 experienced mesh erosion into the vaginal wall as a 13 result of a defect in the Ethicon TVT sling? 14 A No. 15 Q Is it not, that is not your opinion? 16 A That is not my opinion. 17 Q So you're saying that she experienced erosion 18 of mesh into the vaginal wall because that is a known 19 risk of this particular procedure, a procedure that you 20 do; correct? 21 A It's a known risk. I've had erosions of 22 slings into the vaginal wall with my patients as well. 23 It's a known risk. We talk with the patients about the 24 complication, the potential for that. 25 Q And do you agree, Dr. Hoyte, that if Case 2:12-cv-01712 Document 51-10 Filed 07/08/16 Page 5 of 10 PageID #: 382 Lennox Hoyte, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 12 (Pages 42 to 45) Page 42 1 Dr. Patterson, the implanting physician, had used the 2 Desara midurethral retropubic sling, Ms. Suter may well 3 have had erosion in that instance? 4 A I've had erosions with the Desara sling and 5 other surgeons have, if that answers your question. 6 They're rare but I've had them. 7 Q There are risk factors, patient-specific risk 8 factors for erosion; correct? 9 A We talk about those; yes. 10 Q Is smoking one of those risk factors? 11 A Yes. 12 Q Do you counsel patients that the risk for them 13 of vaginal erosion of the sling is greater if they are a 14 heavy smoker? 15 A I would, yes. 16 Q Did you see in Ms. Suter's records that she 17 has been a smoker since age 15? She is now 48. She was 18 46 when the erosion was discovered. So she had been 19 smoking for 31 years? 20 A I recall a 30-year-plus pack smoking history. 21 I didn't look at her age when she started. 22 Q So a 31-year history of smoking about a pack a 23 day of cigarettes, you agree that that would increase 24 the risk of mesh erosion in Ms. Suter? 25 A I would say yes. It would have been helpful Page 43 1 to have had that in the IFU. 2 Q Is smoking a -- does it pose risk for any 3 surgery to patients for wound healing? 4 A Yes. 5 Q Do you do surgery on smokers? 6 A Yes. 7 Q Surgery isn't contraindicated if they're a 8 smoker, it's just riskier if they're a smoker; correct? 9 A Well, all surgical intervention should be 10 based on a proper risk/benefit analysis and a discussion 11 of the risks with the patient compared to the benefit 12 that the patient's hoping to derive. I think, for 13 example, a patient with appendicitis who if not operated 14 on would die and you know that, then smoking risk factor 15 becomes less of a deterrent to performing appendicitis 16 surgery. So it's risk/benefit analysis. 17 Q Correct. Is the risk posed by smoking -- the 18 risk that someone will encounter entering surgery that 19 is posed by smoking, is that known to surgeons? 20 A Yes. 21 Q You state in your report that Ms. Suter 22 remains at risk for additional exposures of the 23 remaining portions of the synthetic polypropylene sling. 24 I believe that's at page 12 of your report. 25 A Yes. Page 44 1 Q Is it your opinion, Dr. Hoyte, that 2 Ms. Suter -- that it's more likely than not that 3 Ms. Suter will have future mesh erosion or just that 4 it's a possibility down the road? 5 A So it's a possibility. And I've seen in my 6 personal experience that if a mesh, transvaginal mesh, 7 product is eroded in one location, to just remove the 8 eroded section, patients often come back with an erosion 9 in another location. I take Dr. Horbach's point well in 10 that the remaining sections of her sling are in the 11 retropubic area away from the vaginal wall 12 theoretically. Based on what Dr. Azadi described, he 13 took out the suburethral part in contact with the 14 vagina. I believe that Ms. Suter's risk for erosion is 15 present, but Dr. Horbach is correct because of the 16 location of the sling, less likely for that future 17 erosion to happen. But I must point out that there are 18 portions of the retropubic sling that sit under the skin 19 in the suprapubic tissues that are close to the outside 20 that are at risk for future erosion. However, I have 21 not seen erosions happen in the suprapubic area -- 22 Q So -- 23 A -- personally. 24 Q Okay. So given what you just said, Doctor -- 25 and I appreciate that explanation, that was helpful -- Page 45 1 it's your opinion that although future erosion is 2 possible, am I correct that you're not saying you think 3 future erosion in Ms. Suter's case from the remaining 4 mesh in the suprapubic area is probable? 5 A Retropubic area. 6 Q I'm sorry. Retropubic area. 7 A I'm sorry. I don't mean to lecture. But I 8 think I understand the question. And so I think my 9 personal belief is that the risk of erosion is higher 10 when there's synthetic material in contact with the 11 vagina. If I believe Dr. Azadi's report, which I do, he 12 took out the part of the sling that's most likely to be 13 in contact with the vaginal wall, so the remnant still 14 potentially is undergoing a foreign body chronic 15 inflammatory reaction. Because of its distance from the 16 vaginal wall, the likelihood of that erosion occurring 17 may be lower, but I don't know lower than what. 18 Q So I guess I'm trying to understand, Doctor. 19 Can you say whether it's probable that she will have 20 future erosion? Can you make that opinion today? 21 A When I think of probability, I think about, 22 you know, high -- so her risk of erosion is not a 23 hundred percent and it's not zero. Is it 50 percent? I 24 don't think so. Is it 2 percent? I don't think so. I 25 just don't know where that line would be. Case 2:12-cv-01712 Document 51-10 Filed 07/08/16 Page 6 of 10 PageID #: 383 Lennox Hoyte, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 13 (Pages 46 to 49) Page 46 1 Q So you're not able to say at this point that 2 it's more likely than not that she will have future 3 erosion, are you? 4 A I'm -- no. Right, correct. 5 Q And, again, as we discussed already, the risk 6 of erosion is a known risk for all retropubic 7 midurethral polypropylene slings; correct? 8 A Yes. 9 Q And the risk of future erosion after excision 10 of the vaginal portion of the mesh would be a risk of 11 all polypropylene midurethral slings; correct? 12 A So if a -- let me answer that I think the way 13 that it should be answered. From what I've seen with my 14 extensive experience with implanting meshes and taking 15 them out, once a polypropylene mesh erodes, the risk of 16 more polypropylene eroding in that patient is very high, 17 relatively higher than the initial erosion. So once 18 eroded, I believe those patients tend to come back with 19 more erosions in different locations. That's what I've 20 seen based on my experience. 21 Q And that would be true of the Desara sling as 22 well as the -- 23 A All polypropylene. 24 Q It's not unique to the Ethicon TVT sling? 25 A I'm saying all polypropylene. Page 47 1 Q And did I hear you, Doctor, earlier say that 2 you have not actually seen a subsequent erosion of mesh 3 under the circumstances that we have in Ms. Suter, that 4 is, where it's not adjacent to the vaginal wall? 5 A I'm not saying that I have not seen it. I 6 don't know that one comes to mind right now, but I've 7 had multiple episodes of prior eroded retropubic slings 8 partially resected that I've had to go and take out more 9 eroded sling. I've seen that. 10 Q And were those subsequent erosions also into 11 the vaginal wall? 12 A Yes. 13 Q We talked about that one of your opinions is 14 that the TVT caused vaginal bleeding in Ms. Suter. She 15 was not complaining of vaginal bleeding when you saw 16 her; correct? 17 A Correct. 18 Q When was the vaginal bleeding then that you 19 say was caused by the TVT? 20 A Dr. Azadi's note of 2014 talked about mesh 21 erosion, vaginal bleeding with the patient complaining 22 of vaginal pain, pain with intercourse. The exam 23 revealed erosion in the sling and suburethral area. It 24 was tender to palpation. And erosion of the sling will 25 correlate with the vaginal bleeding that the patient Page 48 1 complained of. 2 Q So the vaginal bleeding was in 2014 and it was 3 in your opinion as a result of the fact that the mesh 4 had eroded into the vaginal wall? 5 A That's my opinion. 6 Q And did that vaginal bleeding then resolve 7 after Dr. Azadi's removal of the vaginal portion of the 8 mesh in 2014? 9 A I have not seen more complaints of vaginal 10 bleeding since the excision or the resection. 11 Q And vaginal bleeding is a known risk of mesh 12 erosion; correct? 13 A Eroded mesh will probably go along with 14 bleeding. 15 Q And we've already talked about the fact that 16 mesh erosion is a known risk of all polypropylene 17 midurethral retropubic slings; correct? 18 A We talked about that, yes. 19 Q So the vaginal bleeding that she experienced 20 was one of the -- 21 A Consequences. 22 Q -- consequences of the known risk of mesh 23 erosion; correct? 24 A Of the erosion, which is a known risk. 25 Q And we talked a little bit, Doctor, about your Page 49 1 diagnosis of myofascial pain. Just to sort of generally 2 educate me, what is myofascial pain? 3 A Are you familiar with the term "charley 4 horse"? 5 Q Absolutely. 6 A I don't know if you played sports or do play 7 sports, but sometimes you can get an injury to muscle 8 because of overuse or maybe a strike injury to an area 9 and the muscle will get tight and very painful. We call 10 that a charley horse. That's, in fact, because the 11 muscle belly has cramped up and the cramped area is very 12 tender. That is myofascial pain. Myo means muscle. 13 Fascia means the tissue surrounding the muscle. 14 Myofascial. The muscle and the tissue around can also 15 react by sending pain signals to the brain. So it's a 16 charley horse in the vagina, in the pelvic floor 17 muscles. 18 Q So myofascial pain -- and thank you. That was 19 a very helpful explanation. Myofascial pain can be 20 anywhere in the body because there are muscles and 21 tissues all over the body; in this case you diagnosed 22 Ms. Suter with myofascial pain of the pelvic floor 23 muscle? 24 A Correct. 25 Q And does that muscle have a name? Case 2:12-cv-01712 Document 51-10 Filed 07/08/16 Page 7 of 10 PageID #: 384 Lennox Hoyte, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 14 (Pages 50 to 53) Page 50 1 A The levator ani. 2 Q That's L-E-V-A-T-O-R? 3 A L-E-V-A-T-O-R. 4 Q A-N-I? 5 A A-N-I. 6 Q And you said earlier, Doctor, that it's 7 possible that her vaginal pain progressed to the levator 8 ani -- 9 A Yes, ma'am. 10 Q -- muscle. Are there other -- 11 A Let me see if I can explain that a little bit 12 better. The pelvic floor muscles surround the vagina. 13 Whenever there's pain in the pelvis, the lower abdomen 14 like Ms. Suter had, or, you know, pain in the pelvic 15 floor area, one of the reactions seems to be that the 16 pelvic floor muscles will tighten in response to that 17 pain. Sometimes people consciously tighten their pelvic 18 floor muscles. Sometimes the pelvic floor muscles react 19 by tightening. And by staying tight for long periods of 20 time, that's how the myofascial pain develops. 21 Does that answer your question? 22 Q That does. Thank you. 23 Do you agree, Doctor, that there are other 24 possible origin sources of pain that progress to the 25 pelvic floor muscles? Page 51 1 A Yes; abdominal pain. 2 Q How about back pain? 3 A I have not seen it as often, but certainly 4 back pain can radiate enough that could become part of 5 the pathway for myofascial pain. Chronic narcotic use 6 can lead to constipation, which could cause pain, which 7 could lead also to myofascial pain. 8 Q Are you aware of Ms. Suter's history of 9 chronic back pain? 10 A Yes. 11 Q She's had two surgeries and multiple steroid 12 injections in attempt to relieve her back pain? 13 A Yes. 14 Q So it's possible that her back pain could have 15 progressed to the pelvic floor myofascial pain? 16 A Back pain, abdominal pain, vaginal pain. 17 Q And she had abdominal pain based on a history 18 of extensive dense adhesions; correct? 19 A Fibroid surgery, adhesiolysis, correct. 20 Q So that's another potential source of the pain 21 that progressed to the pelvic floor myofascial -- 22 A Abdominal pain, back pain, vaginal pain could 23 all lead to or progress to myofascial pain. 24 Q And at this point given her history of all of 25 these conditions and symptoms, you're not able to say to Page 52 1 a reasonable degree of medical probability whether one 2 particular origin, the back, the abdomen, the vagina, or 3 some combination of them contributed to her pelvic floor 4 muscle pain? 5 A It's more likely that some combination of them 6 contributed or progressed to her myofascial levator ani 7 pain. 8 Q And you also are of the opinion that Ms. Suter 9 has dyspareunia as a result of the TVT sling; correct? 10 A I was not clear that I saw any evidence of 11 dyspareunia prior to the TVT sling based on the review 12 of the surgical records that I had -- I mean the 13 clinical records that I had. I do see dyspareunia 14 thereafter. I do understand that myofascial pain will 15 cause dyspareunia. And dyspareunia can also be caused 16 by eroded mesh as well. 17 Q Doctor, in the report, the IME portion of your 18 report of your medical exam on page 1, you say -- let me 19 just ask you, too. The first two pages of the medical 20 exam report, are those basically the history that you 21 took from the patient? 22 A The first paragraph, the prose section, is 23 what I personally took from the patient in that two-page 24 report that you will get from us. The second section is 25 the 13 system review and following that came from the Page 53 1 21-page report that she filled out. The examination 2 came from the examination that I performed. 3 Q Okay. Thank you. So on the first page the -- 4 A Narrative. 5 Q -- five narrative paragraphs, that's based on 6 your interview with the patient? 7 A That's what she told me, yes, to my face. 8 Q Okay. And the third paragraph down says: 9 "Following the sling procedure in 2008, she developed 10 worsening paining with intercourse..."? 11 A That's what she said. 12 Q So does that suggest to you that she had pain 13 with intercourse before and it was worse after the 14 sling? 15 A That statement certainly does suggest it. I 16 don't document that she said it, but I'm thinking that 17 if I write "worsening pain," that she may have had pain 18 before, which wouldn't really be surprising because of 19 the abdominal -- history of abdominal pain that she's 20 had before. 21 Q A little bit further actually in that same 22 paragraph, you state: "Following sling placement, she 23 also noticed worse pain with intercourse compared to 24 before the sling..." 25 So, again, does that suggest to you, Doctor, Case 2:12-cv-01712 Document 51-10 Filed 07/08/16 Page 8 of 10 PageID #: 385 Lennox Hoyte, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 15 (Pages 54 to 57) Page 54 1 that she did have pain with intercourse before the sling 2 and she's telling you that it was worse after the sling? 3 A That is correct. And I wouldn't be surprised 4 by that based on the patient's history. 5 Q So are you able to say, Doctor, whether the 6 pain with intercourse that she experiences now is due to 7 the mesh erosion in 2014? 8 THE WITNESS: Do you need a break? 9 (Discussion off the record.) 10 THE WITNESS: Would you mind repeating the 11 question? 12 MS. WETTLE: Sure. 13 BY MS. WETTLE: 14 Q So are you able to say, Doctor, whether the 15 pain with intercourse that she experiences now is due to 16 the mesh erosion in 2014? 17 A I would say, I think I said before, that it's 18 due to myofascial issues in the pelvic floor in 19 combination with the pain may be related to the adhesion 20 and whatnot that she had. I made an attempt to connect 21 the myofascial issue with the fact that there's a prior 22 erosion that caused pain at the time, which contributed 23 to the progression to myofascial pain along with her 24 other sources. 25 Q In your examination did you detect any vaginal Page 55 1 pain at all? I didn't see it in your report. 2 A So the place where I talk about pain, so if 3 you look on page 4 of 8 where we get down to the 4 perineum, so negative perineocele, negative perineal 5 descent, that's structural. Vaginal palpation, there's 6 no apex tenderness. The top of the vagina is nontender. 7 The bladder and the bladder neck, which is where the 8 sling would be, are nontender. There's no tenderness of 9 anterior or posterior wall. And I didn't feel any 10 vaginal foreign body. 11 So what I'm saying in this part of the exam is 12 that there is no vaginal pain. There's pain in the 13 pelvic floor muscle. 14 Q Thank you. And is there any way, Doctor, that 15 you can determine either by her history or by exam how 16 much of her dyspareunia is attributable to the abdominal 17 adhesions that she had before the TVT and the myofascial 18 pain in the pelvic floor muscle? 19 A So I'm very clear that based on my 20 examination, the vast majority of her dyspareunia is 21 related to pelvic muscle spasm and myofascial pain. I 22 think we talked about the three sources of how that 23 myofascial pain could have progressed, one of which was 24 the vaginal pain related to the erosion, which was then 25 corrected, the back pain, and the abdominal pain. All Page 56 1 three of them contributed. I can't give you a 2 percentage. But it's important to note that when I 3 examined her, she did not have tenderness of the vaginal 4 apex, which makes abdominal source unlikely, which 5 leaves us with the back and the prior insult from the 6 vaginal erosion as the sources. 7 Q Her back pain is ongoing; correct? 8 A I'm not a back doctor but she did report a 9 history of back pain. And she had a cervical neck 10 fusion there at some point, which can also cause pain. 11 Q Is dyspareunia a self-reported symptom? 12 A Patients can say it hurts when I have 13 intercourse. So I think dyspareunia means pain with 14 intercourse; so yes. 15 Q But the diagnosis of it is the patient 16 reporting that they are having pain with intercourse; 17 correct? 18 A Well, the symptom of pain with intercourse 19 would prompt a competent physician to go looking to see 20 if they can replicate that pain and we then get to say 21 based on examination the pain is a result of muscle 22 spasm, vaginal tenderness, apex tenderness, adnexal 23 tenderness. We can say why or we can say I can't find 24 anything that would replicate the patient's symptoms, in 25 which case we would just say dyspareunia and we can't Page 57 1 identify a cause. 2 Q And what -- can you describe for us the 3 examination that you conducted on which you base your 4 diagnosis of myofascial pain of the levator ani? 5 A Sure. Think of the levator ani as a V-shaped 6 muscle set that surrounds the vagina, that cradles the 7 vagina, if you will. If you put your wrists together 8 and let your fingers go out to the left and right in the 9 shape of a V, the fingers and palms would be the levator 10 ani. The exam involves putting the fingers in the 11 vagina, fingers down, and pressing to the left and right 12 side where the levator ani muscles would be. So if you 13 press on those muscles on the left and right and you 14 feel either tight bands or pain when you compress the 15 muscle, you press on the muscle, that would allow you to 16 say she has myofascial pain. 17 Q Okay. 18 A If you just lightly touch the vaginal walls 19 and the vaginal apex and that hurts, then that leads you 20 to say it's vaginal pain. If there's a doubt about 21 whether there's vaginal or levator ani pain, then a 22 transrectal examination palpating the levator ani would 23 separate the two conditions. So if there's pain with 24 the vaginal exam but not with the rectal exam, that then 25 leads you to the vagina as the source of pain. Case 2:12-cv-01712 Document 51-10 Filed 07/08/16 Page 9 of 10 PageID #: 386 Lennox Hoyte, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 20 (Pages 74 to 77) Page 74 1 have. 2 MS. WETTLE: That's all I have on this one. 3 MR. SAUNDERS: Very well. 4 You have a right to read it if it's typed up 5 or you can waive that right. 6 THE WITNESS: I'd like to read it. 7 MR. SAUNDERS: Very well. So we need to make 8 sure she has your phone number before we leave so 9 she can call you when the transcript is done. 10 (Witness excused.) 11 (Whereupon the deposition concluded at 11:04 12 a.m. Reading and signing was not waived.) 13 - - - 14 15 16 17 18 19 20 21 22 23 24 25 Page 75 1 CERTIFICATE OF OATH 2 STATE OF FLORIDA ) 3 COUNTY OF HILLSBOROUGH ) 4 5 I, the undersigned authority, certify that LENNOX 6 HOYTE, M.D., personally appeared before me and was duly 7 sworn the 30th day of June, 2016. 8 Witness my hand and official seal this 5th day of 9 July, 2016. 10 11 KIMBERLY A. OVERWISE, FPR, CRR Notary Public No. FF160203 12 State of Florida at Large My Commission Expires: 9/16/2018 13 14 15 16 17 18 19 20 21 22 23 24 25 Page 76 1 DEPOSITION CERTIFICATE 2 3 I, KIMBERLY A. OVERWISE, a Florida Professional 4 Reporter and Certified Realtime Reporter, do hereby 5 certify that I was authorized to and did 6 stenographically report the foregoing deposition of 7 LENNOX HOYTE, M.D.; that a review of the transcript was 8 not waived; and that the transcript is a true record of 9 the testimony given by the witness. 10 I further certify that I am not a relative, 11 employee, attorney, or counsel connected with the action 12 and nor am I financially interested in the action. 13 Dated this 5th day of July, 2016. 14 15 16 ______________________________ KIMBERLY A. OVERWISE, FPR, CRR 17 18 19 20 21 22 23 24 25 1 - - - - - - E R R A T A 2 - - - - - - 3 4 PAGE LINE CHANGE 5 ____ ____ ____________________________ 6 REASON: ____________________________ 7 ____ ____ ____________________________ 8 REASON: ____________________________ 9 ____ ____ ____________________________ 10 REASON: ____________________________ 11 ____ ____ ____________________________ 12 REASON: ____________________________ 13 ____ ____ ____________________________ 14 REASON: ____________________________ 15 ____ ____ ____________________________ 16 REASON: ____________________________ 17 ____ ____ ____________________________ 18 REASON: ____________________________ 19 ____ ____ ____________________________ 20 REASON: ____________________________ 21 ____ ____ ____________________________ 22 REASON: ____________________________ 23 ____ ____ ____________________________ 24 REASON: ____________________________ 25 Case 2:12-cv-01712 Document 51-10 Filed 07/08/16 Page 10 of 10 PageID #: 387 EXHIBIT K Case 2:12-cv-01712 Document 51-11 Filed 07/08/16 Page 1 of 10 PageID #: 388 Edward N. Willey, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS Page 1 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 Master File No. THIS DOCUMENT RELATES TO THE 2:12-MD-02327 FOLLOWING CASES IN WAVE 2 OF MDL MDL 2327 200: JOSEPH R. GOODWIN Carol Ann Suter et al. v. Ethicon,U.S. DISTRICT JUDGE Inc., et al. Civil Action No. 2:12-cv-01712 _ _ _ _ _ _ _ _ _ _ _ _ _ / DEPOSITION OF: Edward N. Willey, M.D. DATE: June 15, 2016 TIME: 10:30 a.m. - 2:45 p.m. PLACE: 6727 First Avenue South, Suite 103 St. Petersburg, Florida 33707 REPORTED BY: NANCY H. SWARTZ Court Reporter Notary Public Commission No. FF908705 Case 2:12-cv-01712 Document 51-11 Filed 07/08/16 Page 2 of 10 PageID #: 389 Edward N. Willey, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 9 (Pages 30 to 33) Page 30 1 A. As far as I'm currently aware, but there may be 2 others. 3 Q. And, Doctor, sitting here today, are you aware of 4 any opinions that you have regarding Carolyn Suter that is not 5 included in your report? 6 A. I'm not aware of any, no. 7 Q. Doctor, if we look on page three of your expert 8 report -- 9 A. Yes. 10 Q. Down at the bottom it states: "Documents and 11 Literature Reviewed;" do you see that? 12 A. Yes. 13 Q. And you list one peer-reviewed paper and two Ethicon 14 documents that you reviewed; is that correct? 15 A. That's correct. 16 Q. And, Doctor, we've also marked as Exhibit 2 to your 17 deposition some other documents; is that correct? That you 18 reviewed and relied upon? 19 A. I think I've seen those since, some of them, at 20 least. 21 Q. All right. So if we were to include the documents 22 that are in Exhibit 2 -- 23 A. Yes. 24 Q. -- to the documents and literature reviewed at the 25 bottom of page three, then that would be a complete universe Page 31 1 of the documents that you've reviewed in this litigation, 2 correct? 3 A. As far as I am currently aware, yes. 4 Q. Doctor, did you sign any type of confidentiality 5 agreement with respect to the Ethicon documents that you have 6 reviewed? 7 A. No. 8 Q. Why not? 9 A. It wasn't offered to me. 10 Q. Have you requested to sign a confidentiality 11 agreement? 12 A. No. 13 Q. Doctor, have you tested any of your opinions or 14 theories in this litigation so far? 15 A. I think that's what the trial will be for. I 16 haven't tested them, no. 17 Q. Have you published any of the opinions that you're 18 offering today, other than -- 19 A. Only to the extent that I've created this report. 20 If you have something else in mind, the answer is no. 21 Q. Doctor, if we look at your report, page three -- I'm 22 sorry. Paragraph three on page one. 23 A. Oh, paragraph three, the number three. 24 Q. It says you have processed more than 5,000 cases? 25 A. Yes. Page 32 1 Q. Is this the first case you've processed for vaginal 2 mesh? 3 A. Well, as I told you, there's four cases from 10 or 4 so years ago where all I did was accumulate and store the 5 material. Other than that, yes. 6 Q. And do you know the manufacturer for those cases 10 7 years ago? 8 A. I may have at the time, I don't currently recall. 9 Q. And, Doctor, based upon -- strike that. 10 Is it your best guess -- strike that. 11 A. That's not a guess. 12 Q. Is this case for Carolyn Suter the first time that 13 you have processed a vaginal mesh case where the mesh has been 14 manufactured by Ethicon? 15 A. Well, I don't know whether the others were 16 manufactured by Ethicon or not. I doubt it, but I don't know 17 that. 18 Q. So would this case be the first case? 19 A. With that reservation, yes. 20 Q. Doctor, have you ever treated patients? 21 A. Well, no doctor can avoid that, but I've never made 22 a practice of treating patients on a regular basis. 23 Q. When's the last time you've treated a patient? 24 A. I haven't done that on a regular basis ever. On the 25 other hand, I've done things like write prescriptions as Page 33 1 accommodation or little things. 2 Q. Well, my question is, Doctor, when's the last time 3 you've treated a patient? 4 A. I don't treat patients. 5 Why are we pounding the same ground over and over? 6 Q. Is your medical license current? 7 A. Of course. 8 I could, I just don't choose to. 9 Q. Doctor, on Page 2, Paragraph 12, where you wrote: 10 "In this case, cardiac pathology and neuropathology 11 practitioners were consulted." 12 Why did you write that? 13 A. I wrote that because it was applicable to a 14 different case. 15 Q. Was that just a cut-and-paste job from another case? 16 A. Right. It's boiler plate. 17 Q. Okay. Doctor -- 18 A. I'm personally responsible for that. I'm not going 19 to blame my people. 20 Q. Doctor, how much more language in your expert report 21 is boiler plate? 22 A. I think probably everything from 11 and 12 on is 23 pretty much unique to this case. I don't believe there's any 24 opportunity to put in the information, such as my name as 25 Edward Willey, et cetera. Case 2:12-cv-01712 Document 51-11 Filed 07/08/16 Page 3 of 10 PageID #: 390 Edward N. Willey, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 10 (Pages 34 to 37) Page 34 1 Q. Doctor, have you ever published any articles on 2 mesh? 3 A. No. 4 Q. Have you ever made any presentations or done any 5 research experiments on mesh? 6 A. No. 7 Q. Have you ever published or presented on dyspareunia 8 or pelvic pain or any other type of urinary dysfunction? 9 A. No. 10 Q. Have you ever published or presented on PROLENE or 11 polypropylene? 12 A. No, I'm not a material scientist. 13 Q. Doctor, do you still advertise your services? 14 A. I just as soon nobody knew about it. I'm too busy. 15 Q. Do you still advertise your services? 16 A. No, I don't advertise my services. 17 Q. Have you ever advertised your services? 18 A. Well, it's possible in decades before it's been 19 listed or things of that character, but I don't advertise. I 20 do have a website. Do you consider that advertising? 21 Q. What percentage of your income do you receive 22 working as an expert witness? 23 A. Well, as a witness it's relatively small, but as far 24 as consultation, I would say that consultation, including 25 expert witness work, is about two-thirds of my gross revenue. Page 35 1 Q. Where does the other one-third come from? 2 A. I beg your pardon? 3 Q. Where does the other one-third come from? 4 A. That's all passive. 5 COURT REPORTER: I'm sorry? 6 THE DEPONENT: Passive. Investments. 7 BY MR. HUTCHINSON: 8 Q. Investments? 9 A. Investments, mandatory payouts and all sorts of 10 stuff. 11 Q. Doctor, did you read the deposition transcripts of 12 the plaintiff in this litigation? 13 A. I only read a page or two of it. 14 Q. Why didn't you read the entire thing? 15 A. I didn't have time to do that. 16 Q. Did you read any transcripts of the treating 17 physicians -- 18 A. No. 19 Q. -- in this litigation? 20 A. I'm sorry. I apologize. 21 Q. Let's get it clean. 22 A. Go for it. 23 Q. Did you read any of the deposition transcripts of 24 any of the treating physicians in this litigation? 25 A. Full stop. No. Page 36 1 Q. Why not? 2 A. I didn't ask to. They weren't offered to me. 3 Q. Do you plan on doing any additional work or research 4 on this case? 5 A. I will do whatever is required to support the 6 information I collected in looking at the material. 7 Q. But sitting here today, do you have any plans on 8 doing any type -- any additional work or research on this 9 case? 10 A. I have no such plans, no. 11 Q. You don't hold yourself out as an expert on FDA 12 regulations, do you? 13 A. No. 14 Q. Or medical device labeling? 15 A. No. 16 Q. Are you an expert in biomaterials? 17 A. I think that's been asked and answered, but the 18 answer is no. 19 Q. You're not a toxicologist? 20 A. That's correct. Most toxicologists are chemists. 21 Q. You're not an expert chemist? 22 A. No. 23 Q. You're not an epidemiologist? 24 A. I'm not an epidemiologist, I'm not a statistician, 25 I'm not a mathematician, I'm not a physicist. Page 37 1 Q. You're not a material scientist expert either, are 2 you? 3 A. That's been asked and answered. The answer is no. 4 Q. You're not an expert in female anatomy? 5 A. Well, I guess there's various degrees of expertness. 6 I think probably in this issue the urogynecologists are the 7 top of the crop and everybody else is less qualified. 8 I have general information about female anatomy. 9 Q. Do you hold yourself out as an expert in female 10 anatomy? 11 A. I think there's people much more capable than I at 12 that. So, on the other hand, if a court decides that I should 13 answer that type of question, I'll do it. 14 Q. Well, my question to you is, sir, do you hold 15 yourself out as an expert in female anatomy? 16 A. You mean do I advertise myself as such? No, I 17 don't. I don't hold myself out that way. 18 Q. You're not a microbiologist? 19 A. No, that's very sophisticated now. 20 Q. And you're not a urologist or urogynecologist, 21 correct? 22 A. That's correct too. 23 Q. Doctor, have you ever counseled or treated patients 24 with urinary symptoms? 25 A. Well, acute cystitis or something like that, I've Case 2:12-cv-01712 Document 51-11 Filed 07/08/16 Page 4 of 10 PageID #: 391 Edward N. Willey, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 11 (Pages 38 to 41) Page 38 1 even treated a few of those, sure. 2 Q. When was the last time you treated somebody with 3 acute -- what did you say urocystis (phonetic)? I didn't 4 understand you. 5 A. Cystitis. Urinary cystitis. There's more than one 6 type of cyst. 7 Q. When was the last time you treated somebody with 8 urinary cystitis? 9 A. Oh, it's years ago. 10 Q. How many? 11 A. 30, maybe. I don't remember. 12 Q. How many patients have you treated for any type of 13 urinary symptoms? 14 A. An insignificant number. 15 Q. Doctor, you don't counsel or treat patients with 16 dyspareunia, do you? 17 A. No. 18 Q. And you don't prescribe medicine for pelvic pain, do 19 you? 20 A. No, I don't. 21 Q. Do you prescribe medicine for any types of pain? 22 A. Very uncommonly. I do have a license to prescribe 23 narcotics. I can't remember the last time I wrote a 24 prescription for narcotics. 25 Q. Doctor, when's the last time you've written a Page 39 1 prescription for anybody? 2 A. Oh, probably a few months ago. 3 Q. What was it for? 4 A. Laboratory test. 5 Q. What types of tests? 6 A. Probably thyroid. Probably TSH or something. 7 Q. Do you consider yourself an expert on stress urinary 8 incontinence? 9 A. No. 10 Q. You're not an expert on the treatment options for 11 stress urinary incontinence, correct? 12 A. No, there's a substantial collection of different 13 types of treatment. I'm not familiar with that enough to 14 outline any of them. 15 Q. Is it fair to say you've never implanted or 16 explanted vaginal mesh? 17 A. Sure, it's fair to say that. 18 Q. And, Doctor, do you understand the procedure for 19 implanting vaginal mesh? 20 A. Oh, no, I've never put one in. I've never studied 21 it, I don't know anything about it. I'm aware it's done. 22 Q. And, Doctor, do you have any opinions about the 23 biocompatibility of the vaginal mesh in this litigation? 24 A. About the bio -- 25 Q. Biocompatibility? Page 40 1 A. -- compatibility. 2 Well, I have opinions about some aspects of that. 3 It certainly excites an inflammatory response. It excites a 4 healing response with incorporation by scar; and has a foreign 5 body response that's ongoing. So I have some opinions. 6 On the other hand, I'm not a person that determines 7 the merits of one type of product versus another. 8 Q. I may have asked you this already but you're not a 9 biocompatibility expert, correct? 10 A. Not sure you asked exactly that question but you are 11 correct, I'm not. 12 Q. Doctor, in your opinion, how does the mesh elicit a 13 foreign body reaction? 14 A. Oh, that's enormously complicated and I can't 15 imagine being able to describe that adequately. 16 There is a response by a succession of different 17 cellular elements and it's mediated by various cytokines, and 18 it results in incorporation by a foreign body response and 19 excites fibrous tissue. And how that happens is probably 20 stuff that there's a PhD program for. 21 Q. And that would be outside your area of expertise, 22 correct? 23 A. I think so, yes. 24 Q. And, Doctor, is it fair to say that you've never 25 done any work regarding whether or not mesh is biocompatible Page 41 1 in the vaginal area? 2 A. No, I haven't done any work about that. 3 Q. You've never designed any pelvic mesh, have you? 4 A. I hope you realize I'm going to lunch at 12:30 5 because this is very time consuming. 6 But, no, I have not done that. 7 Q. You want to take a break now? 8 A. No, I'll wait. 9 Q. Okay. You've never been involved in any clinical 10 research regarding vaginal mesh, have you? 11 A. No. 12 Q. And, Doctor, have you ever personally inspected a 13 mesh explant of any kind before Carolyn Suter? 14 A. Well, I'm sure I looked at whatever I received in 15 those other cases. I don't remember any of it. 16 Q. Okay. 17 A. In this case I didn't see anything grossly. It was 18 all in a paraffin block and it was all on the slides. 19 Q. And you've never done any type of testing of a mesh 20 explant, correct? 21 A. No. You're talking about mechanically testing it. 22 I have looked at it with a microscope. I've seen it with 23 polarized light. 24 Q. So the record is clear, the only type of testing 25 that you have done is look at mesh under a microscope, Case 2:12-cv-01712 Document 51-11 Filed 07/08/16 Page 5 of 10 PageID #: 392 Edward N. Willey, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 17 (Pages 62 to 65) Page 62 1 A. It just means it's scar on parts of which are more 2 recent than others. 3 Q. I'm sorry? 4 A. It's scar. That's all that means. 5 Q. So that's -- all you're saying is you're seeing 6 scars? 7 A. Right. I'm seeing scars. 8 Q. And, Doctor, you would expect to see scars around a 9 medical device that's implanted in the body; would you not? 10 A. Well, moreover, this has got hollow spaces and the 11 scar is incorporated within. That's the purpose of the mesh 12 as I understand it. 13 Q. All right. So my question is -- move to strike as 14 nonresponsive. 15 You would expect to see scars around a medical 16 device implanted in the body, correct? 17 A. Yes. 18 Q. Doctor, you didn't prepare any of these slides, 19 these slides were sent to you for analysis, correct? 20 A. Correct. 21 Q. Do you know who sent them to you? 22 A. Yup. Steelgate Incorporated, 2307 58th Avenue East, 23 Bradenton, Florida 34203. 24 Q. And do you know what protocol Steelgate used to 25 stain these slides? Page 63 1 A. Yeah, there's a public protocol that's in the -- 2 it's in the thing. 3 You mean as far staining? I don't believe they 4 mentioned anything about staining. 5 Q. And as we sit here today, just so the record is 6 clear, where are these eight slides for Ms. Suter? 7 A. Probably in Federal Express, if I've been correctly 8 informed. 9 Q. Because they've been sent to our pathologist, 10 correct? 11 A. They were sent to your pathologist. I believe they 12 were initially sent to an attorney and the attorney sent them 13 to the pathologist. 14 Q. And why didn't you take any photographs of any of 15 these slides? 16 A. Well, the same reason that Dr. Felix didn't do any 17 special stains, he didn't think it was necessary. I didn't 18 think it was necessary. 19 Q. Doctor, you write under diagnosis: "Vaginal 20 excision of mesh with erosion."? 21 A. Correct. 22 Q. What is eroded, in your opinion? 23 A. Okay. There's a surgical report that indicates, I 24 believe it's Dr. Assey (phonetic), or something, that he's 25 removed this and it's got granulation tissue and eroded. Page 64 1 So that's historical type information that it's 2 eroded. You can't tell that by looking at these slides. 3 Q. All right. 4 A. And you can certainly say it's excised because we've 5 got it, you know. 6 Q. Right. And so -- 7 A. And there's chronic inflammation, hemorrhage. 8 Bacterial growth is interesting. Dr. Felix 9 correctly points out that there isn't any tissue reaction that 10 I can see to the bacterial growth. But he thinks that it's 11 due to growth of that actinomyces, which he identifies, and I 12 can't speciate that way on tissue that has been permitted to 13 collect those organisms and grow them before it was placed and 14 fixed. I think that's highly improbable. 15 And the reason I think that's highly improbable is 16 because the tissue is pretty well preserved. I don't think it 17 would be if it hadn't been fixed. And the fixative does not 18 support bacterial growth. So I think it's either an 19 artifactual accumulation that could be from hematoxylin, which 20 is sometimes contaminated, or it could be from some other 21 source. 22 Q. Doctor, you didn't see any acute inflammation from 23 the slides, did you? 24 A. I didn't , no. 25 Q. And, Doctor, are you able to tell whether or not Page 65 1 there was hemorrhage by looking from these eight slides for 2 Ms. Suter? 3 A. No, that's a clinical finding. All I can say is 4 that when you do surgery, you shed blood, and there's blood in 5 this, but I can't infer from that there's pre-existing 6 hemorrhage. 7 Q. And, Doctor, are you able to tell whether there was 8 exuberant scar with nerves in myofibrils from looking at the 9 eight slides? 10 A. Yes. 11 Q. Doctor, do you have the ability to look at a slide 12 and determine whether or not that patient experienced pain? 13 A. No. And I can't look at the slide and say the 14 patient didn't experience pain either. You look at a slide, 15 you know that tissue is not capable of experiencing anything, 16 it's dead. 17 Q. And, Doctor, you didn't see any tissue necrosis on 18 Ms. Carolyn Suter's slides, did you? 19 A. No, I didn't. As a matter of fact, I'd like to see 20 the other slides because the surgeon described granulation 21 tissue. I don't see any of that. 22 Q. And if we turn to the next page of your report, you 23 write: "Clinicopathological correlation." 24 What does that mean? 25 A. It just means it's an interpretation of the Case 2:12-cv-01712 Document 51-11 Filed 07/08/16 Page 6 of 10 PageID #: 393 Edward N. Willey, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 18 (Pages 66 to 69) Page 66 1 information collected from medical literature from other 2 experts, and from the clinical information associated with 3 Ms. Suter, and relating it to what I see on the slides. 4 Q. And, Doctor, are you stating to a reasonable degree 5 of medical certainty that the mesh caused pelvic pain and 6 dyspareunia in Ms. Suter? 7 A. I can't say it did. On the other hand, it seems 8 like a reasonable likelihood, and it's certainly a cause. And 9 I think Ms. Suter and both the surgeon who removed it and 10 Dr. Mahon (phonetic), who was taking care of her, had the 11 impression that she'd be improved by having that removed. 12 And, indeed, I asked Mr. Saunders about that and 13 he's the one that brought the deposition of Ms. Suter and 14 pointed out to me that she actually did say that the pain was 15 better as a result of -- or after the surgery, so . . . 16 Q. And -- I'm sorry. Are you finished? 17 A. Yeah. Go for it. 18 Q. I didn't want to cut you off. 19 A. Well, you did, but that's all right. I forgive you. 20 Q. I apologize. 21 A. I forgive you. Go ahead. 22 Q. I apologize. Please finish. 23 A. Go ahead. Do your thing. 24 Q. Doctor, why can you not tell us to a reasonable 25 degree of medical certainty that the mesh caused Ms. Suter Page 67 1 vaginal pain and dyspareunia? 2 A. I can't look at a tissue section and say whether or 3 not that is a painful lesion. 4 Q. Thank you. 5 A. That's impossible. 6 Q. Thank you. 7 A. And you can't look at it and say it's not. You have 8 to rely upon other information. 9 Q. And, Doctor, you're not offering any opinions to a 10 reasonable degree of medical certainty about Ms. Suter's pain; 11 is that correct? 12 A. I think that's probably a cause. One of several 13 causes, perhaps, of her pain. She thought so, her doctors 14 thought so. It got better after it was removed. You know, 15 I'm persuaded. 16 And not only that, but other experts have looked at 17 this and accumulated all sorts of literature and they say that 18 one of the complications of this is erosion, bleeding, 19 dyspareunia and pain. And I don't see any reason to contest 20 that. I believe it. 21 Q. Doctor, in all due respect, I'm not trying to cut 22 you off, but in the interest of moving forward -- 23 A. Right. We do want to go to lunch, so that's okay. 24 Q. I need to ask my question again. 25 A. Right. Page 68 1 Q. And, Doctor, you're not offering any opinions to a 2 reasonable degree of medical certainty about Ms. Suter's pain; 3 is that correct? 4 A. I think that what has been removed -- 5 Q. I'm just asking for a yes or no, and then I'll let 6 you explain your answer. I need a yes or no first. 7 My question is -- 8 A. Well, I don't like the word "certainty" because 9 certainty implies something totally different. 10 A reasonable medical probability is that this is one 11 of several causes of her pain. 12 Q. But you can't tell us if it's the sole cause, can 13 you? 14 A. No, I can't tell you that. 15 Q. And, Doctor, my question, just for the record -- and 16 I'm sorry you don't like the term, but I'm going to need to 17 use it anyway. 18 You're not offering any opinions to a reasonable 19 degree of medical certainty about whether or not the mesh 20 caused Ms. Suter any injuries? 21 A. Any injuries? Well, she's got a foreign body 22 response, she's got inflammation, she's got erosion, and she's 23 got pain. Sure, it causes some injuries. 24 Q. Okay. 25 A. It causes dyspareunia and maybe hispareunia Page 69 1 (phonetic). 2 Q. And, Doctor, I'm sorry, but I don't think I 3 understand your testimony. 4 A. Well, that's going to be very difficult for me to 5 have you understand. 6 Q. My question is: Are you stating to a reasonable 7 degree of medical certainty that the mesh caused any injuries 8 in Ms. Suter; yes or no? 9 MR. SAUNDERS: Object to the form. 10 A. Yes, I'm saying that. I believe that symptoms -- 11 BY MR. HUTCHINSON: 12 Q. And what's the basis for that opinion? 13 A. Because the symptoms and signs she complains of were 14 things that other people report with other cases that have 15 that. And she and her doctor that was taking care of her, 16 Dr. Mahon, and her surgeon, all accepted that as a cause of 17 her pain, and the erosion and the dyspareunia, and they 18 treated it and she was better afterwards. Not well, not 19 perfect by any means, but better. 20 Q. And, Doctor, you're not testifying to a reasonable 21 degree of medical certainty about whether or not the mesh 22 caused pelvic pain or dyspareunia, correct? 23 MR. SAUNDERS: Object to the form. 24 A. Well, I thought I already had. I think it caused 25 that. I think it was one of the causes of that. Perhaps even Case 2:12-cv-01712 Document 51-11 Filed 07/08/16 Page 7 of 10 PageID #: 394 Edward N. Willey, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 19 (Pages 70 to 73) Page 70 1 the principle cause. I don't know. 2 By the way, there's a pain clinic record on her. 3 She's apparently using oxycodone on a regular basis because of 4 pain. 5 BY MR. HUTCHINSON: 6 Q. Doctor, did you do a differential diagnosis when 7 reaching that opinion to a reasonable degree of medical 8 certainty? 9 A. One does that always, yes. She could have pain -- 10 Q. My question is: Did you do that? 11 A. Yes. She can have pain from other things. She can 12 have pain from abdominal adhesions. She can have pain from 13 difficulties with the ovaries, which are plastered against the 14 walls of the pelvis. 15 Q. And what did you do to rule out any pelvic pain 16 associated with the adhesions? 17 A. I didn't. All I can say -- 18 Q. Excuse me. Excuse me. 19 What did you do to rule out the pain in her pelvic 20 associated with the ovarian cysts? 21 A. Well, the ovarian cysts had actually been treated 22 one way or another, aspirated, and that sort of thing. So I 23 don't think it's ovarian cyst, but it could be from scar in 24 the pelvis. 25 And I didn't do anything to rule those out. I Page 71 1 recognize that it's a reasonable probability that they do 2 cause problems. 3 Q. Thank you. And, in fact, it's a reasonable 4 probability that they cause vaginal pain and dyspareunia, 5 correct? 6 A. They may have some relationship to that, yes. 7 Q. Thank you. 8 A. On the other hand, I think that the mesh, which is 9 actually located within the wall of the vagina and is eroding 10 into it, is definitely a cause. 11 Q. But you can't tell if it's the sole cause, correct? 12 A. No, I can't tell it's the sole cause. 13 Q. And, Doctor, how many surgically -- strike that. 14 When you reviewed Ms. Suter's records, could you 15 determine whether or not she had a hysterectomy? 16 A. She did have a hysterectomy. 17 Q. Did you rule out a hysterectomy as a cause of pelvic 18 pain and dyspareunia? 19 A. Well, the hysterectomy was long before all of this. 20 I think it was before the -- 21 Q. And, I'm sorry. Move -- that's not responsive. I'm 22 going to move to strike as not responsive. 23 My question is, yes or no, did you rule out a 24 hysterectomy as a possible cause for her pelvic pain or 25 dyspareunia; yes or no? Page 72 1 A. It may be in some way related. I did not rule it 2 out. 3 Q. Thank you. And, Doctor, did you rule out in your 4 differential diagnosis pelvic tumors or fibroids and whether 5 or not they cause dyspareunia or pelvic pain; yes or no? 6 A. Yes. 7 Q. How did you rule them out? 8 A. She had her uterus removed, it had fibroids, and 9 they were removed. 10 Q. Doctor, do you know if Ms. Suter ever complained of 11 pelvic pain before she was implanted with Ethicon's mesh? 12 A. Well, there were very little in the way of records 13 before that. 14 Q. My question to you, sir, is: Do you know whether or 15 not Ms. Suter complained of pelvic pain before she received 16 Ethicon's mesh; yes or no? 17 A. I don't know the details on that. 18 Q. And, Doctor, do you know if Ms. Suter ever 19 complained of dyspareunia before she received Ethicon's mesh? 20 A. I don't know that either. 21 Q. Doctor, is that something you would need to know in 22 making a differential diagnosis, whether or not mesh caused 23 pelvic pain or dyspareunia? 24 A. Well, it would be useful but it's not something I 25 need to know. Page 73 1 Q. In fact, you would always need to know a 2 pre-existing medical condition when doing a differential 3 diagnosis, wouldn't you, sir? 4 A. Yes, but there's nothing about pre-existing medical 5 conditions that would cause erosion, granulation tissue, and 6 bleeding. 7 Q. Doctor, would you defer to a urologist or 8 urogynecologist about whether or not the mesh caused 9 Ms. Suter's pelvic pain and dyspareunia? 10 A. Well, I think they are much more likely to have 11 clinically relevant experience with that. But on the other 12 hand, I don't like deferring to other people because I don't 13 know what they will say be reasonable or not. 14 Q. And, Doctor, did you notice any nerve entrapments 15 from the eight slides you received on Ms. Suter? 16 A. No, I can't recognize nerve entrapments on nerve 17 tissue. 18 Q. And, Doctor, did you see any fibrotic bridging on 19 the eight slides by Ms. Suter? 20 A. Okay. By fibrotic bridging, do you mean fibrosis 21 within the interstices of the mesh; is that your question? 22 Q. That's correct. 23 A. Yes, there's fibrous tissue in the interstices of 24 the mesh. 25 Q. And is that something you noticed in all eight Case 2:12-cv-01712 Document 51-11 Filed 07/08/16 Page 8 of 10 PageID #: 395 Edward N. Willey, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 21 (Pages 78 to 81) Page 78 1 carotid artery or something, and that's not an appropriately 2 designed product, although it's safe for many people. 3 Q. Do you believe that TVT was a safe product for 4 Ms. Suter? 5 A. I think that's going to be an issue of the court to 6 decide, not me. 7 Q. Do you have any opinions, as we sit here today, on 8 whether or not TVT was a safe product for Ms. Suter? 9 A. For her it wasn't, no. 10 Q. And why do you believe it wasn't a safe product for 11 her? 12 A. Because I think she had complications from it, 13 including erosion, and chronic inflammation, and pain, and 14 dyspareunia. 15 Q. And, Doctor, do you believe that the TVT was an 16 effective product to treat Ms. Suter's stress urinary 17 incontinence? 18 A. Well, it was certainly planned to be, yes. 19 Q. My question is: Do you believe, as a witness in 20 this case, whether or not the product was effective to treat 21 stress urinary incontinence? 22 A. Well, I don't know the extent to which she had 23 correction of stress incontinence. That's the purpose for it. 24 Q. Doctor, do you believe that Ethicon's mesh was 25 effectively designed? Page 79 1 A. I'm not a design person or a materials person and so 2 I really don't have an opinion about the structure of that or 3 how it's designed or what it should have been. The only thing 4 I can talk about is the tissues I've looked at. 5 Q. So is it fair to say that you're not going to tell 6 the jury that this mesh is defectively designed? 7 A. I don't have any knowledge of the mechanism of 8 design or the structure of design or the process of design. 9 It wouldn't be reasonable for me to argue about design. 10 That's somebody else's issue. 11 Q. And specifically, for Ms. Suter, you're not going to 12 tell the jury that her mesh was defectively designed, are you? 13 A. Well, I think that's -- 14 Q. I'm asking for a yes or no and we'll move on. 15 A. If I'm not mistaken, that's the same question, and 16 the answer is, no, I'm not going to say that. 17 Q. Doctor, are you aware of any mesh used to treat 18 stress urinary incontinence that completely eliminates the 19 risk of injury? 20 A. I think that any product has got a downside and 21 there's a likelihood of injury. Just the same as any drug 22 could have some sort of side effect that's adverse. 23 Q. Doctor, are you aware of any mesh used to treat 24 stress urinary incontinence that significantly reduces the 25 risk of injury? Page 80 1 A. I'm not aware of the various products, no. 2 Q. Do you have any opinions about what would have been 3 a safer alternative of mesh for Ms. Suter? 4 A. No, that's outside my purview. 5 Q. Doctor, do you believe that it was the PROLENE 6 material that caused the chronic inflammation in Ms. Suter? 7 A. Well, it's whatever the product is in the mesh that 8 causes the inflammatory response and the fibrous response, 9 yes. 10 Q. Okay. 11 A. I'm not sure it's properly termed PROLENE, but . . . 12 MR. HUTCHINSON: All right. I'm going to take a 13 quick restroom break. 14 (A recess was taken at 12:21 p.m.) 15 (Back on the record at 12:22 p.m.) 16 CONTINUING EXAMINATION 17 BY MR. HUTCHINSON: 18 Q. Doctor, are you aware of or have you ever heard of, 19 in your capacity as a physician and a pathologist, about 20 PROLENE sutures? 21 A. Well, I'm aware of sutures generally. I don't have 22 any knowledge about their structure. 23 Q. And do you know how long PROLENE sutures have been 24 on the market? 25 A. Oh, it's probably many decades. Page 81 1 Q. Do you have any criticisms of Ethicon's sutures? 2 A. Well, I don't know of any criticism of suture 3 material. 4 Q. And, Doctor, would it be your testimony that people 5 who have received PROLENE sutures have a chronic inflammatory 6 response to that PROLENE material? 7 A. They may. 8 Q. Well, Doctor, how do you account for the millions of 9 PROLENE sutures that have been used for decades in patients? 10 MR. SAUNDERS: Object to the form. 11 A. That's -- comparing a suture with mesh is really not 12 a fair comparison. The mesh is extremely dense, there's a lot 13 of it and it's articulated, whereas the PROLENE suture is not. 14 I think it's a vastly different proposition. 15 BY MR. HUTCHINSON: 16 Q. Doctor, do you have an opinion about whether or not 17 the implanting physician for Ms. Suter committed malpractice 18 from using a PROLENE mesh to treat Ms. Suter's urinary 19 incontinence? 20 MR. SAUNDERS: Object to the form. 21 A. Okay. I don't have an opinion about that, but more 22 than that, I'm just not qualified to judge a gynecologist's 23 practice. I'm not a gynecologist. I don't do those things. 24 BY MR. HUTCHINSON: 25 Q. Doctor, have you ever done any research whatsoever Case 2:12-cv-01712 Document 51-11 Filed 07/08/16 Page 9 of 10 PageID #: 396 Edward N. Willey, M.D. Golkow Technologies, Inc. - 1.877.370.DEPS 36 (Pages 138 to 140) Page 138 1 REPORTER'S CERTIFICATE 2 3 STATE OF FLORIDA 4 COUNTY OF HILLSBOROUGH 5 I, Nancy H. Swartz, Florida Court Reporter, Notary 6 Public, certify that I was authorized to and did stenographically report the deposition of Edward N. Willey, M.D., 7 that a review of the transcript was requested; and that the transcript is a true and complete record of the testimony 8 given by the witness. 9 10 I further certify that I am not a relative, employee, attorney, or counsel of any of the parties, nor am I 11 a relative or employee of any of the parties' attorney or counsel connected with the action, nor am I financially 12 interested in the action. 13 14 Dated this 20th day of June, 2016. 15 16 _______________________________ 17 Nancy H. Swartz, Court Reporter 18 19 20 21 22 23 24 25 Page 139 1 - - - - - - E R R A T A 2 - - - - - - 3 4 PAGE LINE CHANGE 5 ____ ____ ____________________________ 6 REASON: ____________________________ 7 ____ ____ ____________________________ 8 REASON: ____________________________ 9 ____ ____ ____________________________ 10 REASON: ____________________________ 11 ____ ____ ____________________________ 12 REASON: ____________________________ 13 ____ ____ ____________________________ 14 REASON: ____________________________ 15 ____ ____ ____________________________ 16 REASON: ____________________________ 17 ____ ____ ____________________________ 18 REASON: ____________________________ 19 ____ ____ ____________________________ 20 REASON: ____________________________ 21 ____ ____ ____________________________ 22 REASON: ____________________________ 23 ____ ____ ____________________________ 24 REASON: ____________________________ 25 Page 140 1 2 ACKNOWLEDGMENT OF DEPONENT 3 4 I,_____________________, do 5 hereby certify that I have read the 6 foregoing pages, and that the same is 7 a correct transcription of the answers 8 given by me to the questions therein 9 propounded, except for the corrections or 10 changes in form or substance, if any, 11 noted in the attached Errata Sheet. 12 13 14 _______________________________________ 15 EDWARD N. WILLEY, M.D. DATE 16 17 18 Subscribed and sworn to before me this 19 _____ day of ______________, 20____. 20 My commission expires:______________ 21 ____________________________________ 22 Notary Public 23 24 25 Case 2:12-cv-01712 Document 51-11 Filed 07/08/16 Page 10 of 10 PageID #: 397