Marshall et al v. Ethicon, Inc. et al

MOTION

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

IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA AT CHARLESTON IN RE ETHICON, INC., PELVIC REPAIR SYSTEM PRODUCTS LIABILITY LITIGATION Master File No. 2:12-MD-02327 MDL 2327 JOSEPH R. GOODWIN U.S. DISTRICT JUDGE THIS DOCUMENT RELATES TO: Natalie C. Marshall and David R. Marshall v. Ethicon, Inc. et al. Case No. 2:12-cv-2077 DEFENDANTS’ MOTION FOR SUMMARY JUDGMENT Defendants Ethicon, Inc. and Johnson & Johnson (collectively, “Ethicon”), pursuant to Federal Rule of Civil Procedure 56, move for summary judgment on all Plaintiffs’ claims. In support of this motion, Ethicon states: 1. All of Plaintiffs’ claims are barred by either Tennessee’s one-year statute of limitations for personal injury claims or four-year statute of limitations for warranty claims. 2. Plaintiffs’ claims based in negligence (Count I (negligence), Count X (negligent infliction of emotional distress), and Count XIV (gross negligence)), fraud (Count VI (fraud), Count VII (fraudulent concealment), Count VIII (constructive fraud), Count IX (negligent misrepresentation)), warranty (Counts XI, XII (breach of express and implied warranties)), violation of consumer protection laws (Count XIII), and unjust enrichment (Count XV) should all be dismissed as duplicative as each of these claims is subject to the Tennessee Product Liability Act (TPLA). Case 2:12-cv-02077 Document 65 Filed 07/08/16 Page 1 of 4 PageID #: 304 2 3. Plaintiffs cannot recover for their failure-to-warn claim (Count III) as Natalie Marshall’s implanting physician already knew of the risks of the events at issue so no additional warning would have educated him any further, he did not rely on the warnings Ethicon provided, and even if Ethicon had explicitly warned of all of the risks of those events, he would have implanted the device anyway. 4. Plaintiffs’ manufacturing-defect claim (Count II) fails because Plaintiffs have presented no evidence that Ms. Marshall’s device departed from design specifications. 5. All of Plaintiffs’ information-based claims resting on Ethicon’s alleged misrepresentations or omissions (which presumably include most of Plaintiffs’ claims in this action), are duplicative of Plaintiffs’ failure-to-warn claim and should be dismissed. 6. Plaintiffs’ “strict-liability defective product” claim (Count IV) should be dismissed as there is no such claim under Tennessee law, and any claim based on a product defect is subject to the TPLA’s requirements. 7. Plaintiffs’ consumer-fraud claim (Count XIII) under the Tennessee Consumer Protection Act (“TCPA”) fails as the TCPA does not apply to personal-injury claims, the FDA cleared Ethicon’s prescription medical device for sale and use before it was sold and implanted, and Plaintiffs have offered no expert proof related to the issues of causation or economic damages which are essential elements of any TCPA claim. 8. Plaintiffs’ unjust enrichment claim (Count XV) is improper as Ms. Frazier is asserting personal injury claims rather than a quasi-contractual claim. 9. The loss-of-consortium claim (Count XVI) is derivative of the substantive claims and should be dismissed. Case 2:12-cv-02077 Document 65 Filed 07/08/16 Page 2 of 4 PageID #: 305 3 10. Ethicon incorporates by reference its Memorandum in Support of its Motion for Summary Judgment and the following exhibits: Exhibit Description A Plaintiff Fact Sheet. B Ethicon TVT-O FDA 510k Clearance Letter. C TVT-O – Instructions for Use. D Natalie Marshall Deposition Transcript 3/10/16. E Bruce Farris, MD Deposition Transcript 6/22/16. F Bruce Farris, MD Deposition Exhibit 7 G Bruce Farris, MD Deposition Exhibit 13 WHEREFORE, FOR THESE REASONS and as more fully set forth in Ethicon’s supporting memorandum of law, Ethicon respectfully requests that this Court enter an order granting Ethicon’s Motion for Summary Judgment and dismissing all of Plaintiffs’ claims, with prejudice. Respectfully submitted, /s/ Christy D. Jones Christy D. Jones Butler Snow LLP 1020 Highland Colony Parkway Suite 1400 (39157) P.O. Box 6010 Ridgeland, MS 39158-6010 (601) 985-4523 christy.jones@butlersnow.com Case 2:12-cv-02077 Document 65 Filed 07/08/16 Page 3 of 4 PageID #: 306 4 /s/ David B. Thomas David B. Thomas (W.Va. Bar #3731) Thomas Combs & Spann PLLC 300 Summers Street Suite 1380 (25301) P.O. Box 3824 Charleston, WV 25338 (304) 414-1807 dthomas@tcspllc.com COUNSEL FOR DEFENDANTS ETHICON, INC. AND JOHNSON & JOHNSON CERTIFICATE OF SERVICE I certify that on this date, I electronically filed this document with the clerk of the court using the CM/ECF system, which will send notification of this filing to CM/ECF participants registered to receive service in this MDL. /s/ Christy D. Jones ____ Christy D. Jones 31811848v1 Case 2:12-cv-02077 Document 65 Filed 07/08/16 Page 4 of 4 PageID #: 307 Exhibit A Case 2:12-cv-02077 Document 65-1 Filed 07/08/16 Page 1 of 15 PageID #: 308 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA CHARLESTON DIVISION IN RE: ETHICON, INC. PELVIC REPAIR SYSTEM PRODUCTS LIABILITY LITIGATION THIS DOCUMENT RELATES TO Civil Action No.: 2:12-cv-02077 MDL No. 2327 Natalie C. Marshall and David R. Marshall Name of Plaintiff PLAINTIFF FACT SHEET Each plaintiff who allegedly suffered injury as a result of a pelvic mesh product manufactured or sold by Ethicon, Inc. must complete this Plaintiff Fact Sheet. In completing this Fact Sheet, you are under oath and must answer every question and provide information that is true and correct to the best of your knowledge. If you cannot recall all of the details requested, please provide as much information as you can and then state that your answer is incomplete and explain why as appropriate. If you select an "I Don't 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 information on a reasonable, case-by-case basis pursuant to the Federal Rules of Civil Procedure and as permitted by the applicable Case Management Order. In filling out this form, please use the following definition: “healthcare provider” means any doctor, physician, surgeon, pharmacist, hospital, clinic, center, physician’s office, infirmary, medical or diagnostic laboratory, or other facility that provides medical care or advice, and any pharmacy, x-ray department, radiology department, laboratory, physical therapist or physical Case 2:12-cv-02077 Document 65-1 Filed 07/08/16 Page 2 of 15 PageID #: 309 therapy department, rehabilitation specialist, chiropractor, or other persons or entities involved in the diagnosis, care and/or treatment of you. In filling out this form, the terms "You" or "Your" refer to the person who received pelvic mesh product(s) manufactured or sold by Ethicon, Inc. and who is identified in Question I.1 (a) below. To the extent that the form does not provide enough space to complete your responses or answers, please attach additional sheets as necessary. I. BACKGROUND INFORMATION 1) Please state: a. Full name of the person who received the pelvic mesh product(s), including maiden name: Natalie C. Marshall a/k/a Bartee b. Full name of the person completing this form, if different from the person listed in 1 (a) above, and the relationship of the person completing this form to the person listed in 1 (a) above: Plaintiff completed this form with the assistance of counsel. b. The name and address of your primary attorney: Leslie C. MacLean, Waters & Kraus, LLP 3219 McKinney Avenue Dallas, Texas 75204 2) Your Social Security Number: 3) Your date of birth: 4) Your current residence address: 3 TN If you have lived at this address for less than 10 years, provide each of your prior residence addresses from 2000 to the present: Prior Address Dates You Lived At This Address Not Applicable 2 Case 2:12-cv-02077 Document 65-1 Filed 07/08/16 Page 3 of 15 PageID #: 310 II. CLAIM INFORMATION 1) Please complete the following chart for each implanted Ethicon, Inc. pelvic mesh product. Insert additional lines as necessary. Pelvic Mesh Product and lot number (if sticker affixed, so indicate) Date and Location of Implant Reason for Implant Implanting Doctor and Address Product No. 1: TVT-O System, Lot # 3017495 08/01/2007 Stress Urinary Incontinence Dr. Bruce Fariss, M.D. Lower Keys Urology, PLLC 3714 N. Roosevelt Blvd. Key West, FL 33040 (305) 296-0000 (Doctor moved – this may be current address) Product No. 2: TVT Exact Serial # 3704835 11/11/2013 Recurrent Stress Incontinence Dr. Chad Bryce Bowling, M.D. UT Urogynocology 1932 Alcoa Highway Suite C-450 Knoxville, TN 37920 (865) 305-5940 2) For each pelvic mesh product identified above, describe your understanding of the medical condition for which you received the pelvic mesh product(s): 2007: Stress Urinary Incontinence 2013: Stress Urinary Incontinence and failure of prior mesh 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 X If Yes: a. Provide the date you received the written and/or verbal information or instructions: Not applicable b. Identify by name and address the person(s) who provided the information or instructions: Not applicable c. What information or instructions did you receive? Not applicable 5 Case 2:12-cv-02077 Document 65-1 Filed 07/08/16 Page 4 of 15 PageID #: 311 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 X If Yes, Identify by name and address the doctor who recommended removal and state your understanding of why the doctor recommended removal: Not Applicable 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? 11/11/2013 b. Explain why you consented to have the pelvic mesh product(s), or any portion of it, removed? The mesh had eroded into the vaginal wall, causing pelvic pain and dyspareunia. 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 X 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 6) Do you claim that you suffered bodily injuries as a result of the implantation of any Ethicon, Inc., pelvic mesh product(s)? Yes X No ___ If Yes: a. Describe the bodily injuries, including any emotional of psychological injuries, that you claim resulted from the implantation of the pelvic mesh product(s). 6 Case 2:12-cv-02077 Document 65-1 Filed 07/08/16 Page 5 of 15 PageID #: 312 Pelvic pain, mesh erosion and banding, infections, dyspareunia, recurrence, urinary and bowel problems, bleeding, vaginal scarring, neuromuscular problems, and back pain. 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)? In approximately 2008. c. When did you first attribute these bodily injuries to the pelvic mesh product(s)? I was not aware that the symptoms I was experiencing were related to my pelvic mesh products until I saw an advertisement on television regarding defective mesh devices in approximately 2011. 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): In approximately 2008. e. Are you currently experiencing symptoms related to your claimed bodily injuries? Yes X No ___ If Yes, please describe your current symptoms in detail I continue to have dyspareunia, back pain, pelvic pain, and neuromuscular pain. I also have pain from vaginal scarring. 7 Case 2:12-cv-02077 Document 65-1 Filed 07/08/16 Page 6 of 15 PageID #: 313 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 X No ___ If Yes, please list all doctors you have seen for treatment of any of the bodily injuries you have listed above. Provider Name and Address Condition Treated Approximate Dates of Treatment Dr. Bruce Farris, Urologist Moved – I heard he has since relocated to Florida Mesh Implant Surgery August to September, 2007 Dr Marilyn Gordon OB GYN Morristown, TN 37814 Is now retired OB-GYN, pelvic pain (only saw one time following mesh implant) 2007 to 2008 Dr R. Wayne Hatfield TN Urology Associates 2001 Laurel Avenue Suite 502 Knoxville, TN 37916 Consultation regarding mesh removal December 2011 to January 2012 Dr. C. Bryce Bowling, M.D. UT Urogynocology 1932 Alcoa Highway Suite C-450 Knoxville, TN 37920 Mesh removal surgery October 2013 to 2014 Dr. Erin Saunders Ft Sanders OB GYN Knoxville, TN OB-GYN, pelvic pain and other mesh related symptoms 2012 to 2014 Dr. Michael Tan 7th N. Street Morristown, TN 37814 Family Doctor; pelvic pain, UTIs, and other mesh related symptoms 2007 to Present g. Were you hospitalized at any time for the bodily injuries you listed above? Yes X No ___ 8 Case 2:12-cv-02077 Document 65-1 Filed 07/08/16 Page 7 of 15 PageID #: 314 If Yes, please provide the following: Hospital Name and Address Condition Treated Approximate Dates of Treatment University of Tennessee Medical Center 1924 Alcoa Highway, Knoxville, TN 37920 Mesh Excision and replacement November 2013 7) Other than the Ethicon, Inc. pelvic mesh product(s) that are the subject of your lawsuit, have you been implanted with any other pelvic mesh products? Yes ___ No X If Yes, please provide the following information: a. Product Name(s): Not Applicable b. Date of implantation procedure(s) and name and address of implanting doctor(s): Not Applicable c. Condition(s) sought to be treated through placement of the device(s): Not Applicable d. Whether the product(s) remain implanted inside of you today? Yes X No ___ 8) Are you making a claim for lost wages or lost earning capacity? Yes ___ No X If Yes, state the annual gross income you derived from your employment for each year, beginning five years prior to the implantation of the pelvic mesh product(s) until the present: Not Applicable 9) Are you making a claim for lost out-of-pocket expenses? Yes X No ___ If Yes, please identify and itemize all out-of-pocket expenses you have incurred: 9 Case 2:12-cv-02077 Document 65-1 Filed 07/08/16 Page 8 of 15 PageID #: 315 12) Please list the name and address of any healthcare providers the consortium plaintiff has seen for treatment for any physical, emotional, or psychological injuries or symptoms alleged to be related to the loss of consortium claim. None 13) Have you or anyone acting on your behalf had any communication, oral or written, with any of the defendants or their representatives, other than your attorneys? Yes ___ No X Don’t Know ___ If Yes, set forth the date of the communication, the method of communication, the name of the person with whom you communicated, and the substance of the communication between you and any defendants or their representatives: Not Applicable III. MEDICAL BACKGROUND 1) Provide your current age: 58 Height 60 inches Weight 205 lbs 2) At the time you received each pelvic mesh product(s), please state: 2007: Your age 50 Your approximate weight 200 lbs 2013: Your age 55 Your approximate weight 213 lbs 3) State number of vaginal births you have had? Two 4) State the number of cesarean section births you have had? None 5) In chronological order, list any and all surgeries, procedures, or hospitalizations you had in the 10 year period BEFORE implantation of the pelvic mesh product(s); identifying by name and address the doctor(s), hospital(s) or other healthcare provider(s) involved with each surgery or procedure; and providing the approximate date(s) for each. Insert additional rows as necessary. 11 Case 2:12-cv-02077 Document 65-1 Filed 07/08/16 Page 9 of 15 PageID #: 316 7) To the extent not already provided in the charts above, provide the name, address, and telephone number of every doctor, hospital, or other health care provider from which you have received medical advice and/or treatment for the past 10 years. Insert additional rows as necessary. Name and Specialty Address Approximate Dates/Years of Visits Dr. Ernesto Mejia Pulmonologist 500 McFarland St Suite B Morristown, TN 37814 COPD – Asthma 2014 Dr. Jeff Bearman Cardiologist 501 20th Street Suite 110 Knoxville, TN 37916 HTN, high cholesterol 2014 to 2015 Dr. Robert J. Capps Rheumatology 4707 Papermille Drive NW Suite 200 Knoxville, TN Arthritis 2014 to Present 8) Please describe your physical activities associated with daily living, physical fitness, household tasks, and employment-related activities before the implantation of each pelvic mesh product. Before my Ethicon mesh implants, I had no major restrictions on my physical activity level. I worked as a nurse and was able to attend church every Sunday. I was also able to be active with my two children and five grandchildren. I was able to complete housework and yard work without any limitations. I had a healthy sex life with my husband of thirty years. 9) Please describe your physical activities associated with daily living, physical fitness, household tasks, and employment-related activities after the implantation of the pelvic mesh product(s). Since my Ethicon mesh implants, I have developed excruciating vaginal pain. This affects my ability to perform my job as a nurse at a nursing home. I am not able to be as active with my grandkids or complete the same level of housework or yard work. Also, my sex life is miserable due to painful intercourse and vaginal pain. I feel like I only work, sleep, and sometimes go to church. This has taken an extreme toll on my physical and emotional wellbeing. 10) To the best of your knowledge, have you suffered from any of the following: 13 Case 2:12-cv-02077 Document 65-1 Filed 07/08/16 Page 10 of 15 PageID #: 317 Medical Condition Sought treatment for? Indicate whether condition occurred pre-implant, post- implant or both (explain, if necessary) Adhesions Yes X No ___ Yes ___ No X Pre ___ Post X Bleeding or Clotting Disorders If Yes, please specify disorder: Yes ___ No X Yes ___ No X Pre ___ Post ___ Bowel Obstruction Yes ___ No X Yes ___ No X Pre ___ Post ___ Bowel Perforation Yes ___ No X Yes ___ No X Pre ___ Post ___ Cancer If Yes, please specify type: Yes ___ No X Yes ___ No X Pre ___ Post ___ Chronic Constipation Yes X No ___ Yes X No ___ Pre X Post X Collagen Disorder/Deficiency Yes ___ No X Yes ___ No X Pre ___ Post ___ Connective Tissue Disorder If Yes, please specify disorder: Yes ___ No X Yes ___ No X Pre ___ Post ___ Crohn’s Disease, Irritable Bowel Syndrome, Ulcerative Colitis, or Chronic Diarrhea If Yes, please specify which condition and treatment prescribed: Yes ___ No X Yes ___ No X Pre ___ Post ___ 14 Case 2:12-cv-02077 Document 65-1 Filed 07/08/16 Page 11 of 15 PageID #: 318 Medical Condition Sought treatment for? Indicate whether condition occurred pre-implant, post- implant or both (explain, if necessary) Cystocele Yes ___ No X Yes ___ No X Pre ___ Post ___ Diabetes Yes ___ No X Yes ___ No X Pre ___ Post ___ Diverticulitis Yes X No ___ Yes ___ No X Pre ___ Post X Dyspareunia Yes X No ___ Yes X No ___ Pre ___ Post X Enterocele Yes ___ No X Yes ___ No X Pre ___ Post ___ Fistulas Yes ___ No X Yes ___ No X Pre ___ Post ___ Hernias Yes X No ___ Yes X No ___ Pre ___ Post X Hypertension or High Blood Pressure Yes X No ___ Yes X No ___ Pre ___ Post X Hypotension or Low Blood Pressure Yes ___ No X Yes ___ No X Pre ___ Post ___ Immune System Disease or Dysfunction including HIV/AIDS If Yes, please specify condition: Yes ___ No X Yes ___ No X Pre ___ Post ___ Malnutrition Yes ___ No X Yes ___ No X Pre ___ Post ___ Muscle or Muscle- Wasting Disorder If Yes, please specify disorder: Yes ___ No X Yes ___ No X Pre ___ Post ___ Neuromuscular Disease or Disorder Yes ___ No X Yes ___ No X Pre ___ Post ___ 15 Case 2:12-cv-02077 Document 65-1 Filed 07/08/16 Page 12 of 15 PageID #: 319 Medical Condition Sought treatment for? Indicate whether condition occurred pre-implant, post- implant or both (explain, if necessary) If Yes, please specify disorder: Obesity Yes X No ___ Yes X No ___ Pre X Post X Pelvic Trauma If Yes, please describe trauma: Yes ___ No X Yes ___ No X Pre ___ Post ___ Pelvic Tumors or Fibroids Yes ___ No X Yes ___ No X Pre ___ Post ___ Peritonitis/Sepsis Yes ___ No X Yes ___ No X Pre ___ Post ___ Rectocele Yes ___ No X Yes ___ No X Pre ___ Post ___ Recurrent or Chronic Vaginal or Bladder Infections If Yes, please specify location and nature of infections: Yes ___ No X Yes ___ No X Pre ___ Post ___ Recurrent Vaginal Pain If Yes, please describe the nature of pain experienced: Yes X No ___ Yes X No ___ Pre ___ Post X I was told my pelvic pain was from “banding” of the product Urinary Incontinence Yes X No ___ Yes X No ___ Pre X Post X Urinary Retention Yes ___ No X Yes ___ No X Pre ___ Post ___ Uterine Prolapse Yes ___ No X Yes ___ No X Pre ___ Post ___ 16 Case 2:12-cv-02077 Document 65-1 Filed 07/08/16 Page 13 of 15 PageID #: 320 Medical Condition Sought treatment for? Indicate whether condition occurred pre-implant, post- implant or both (explain, if necessary) Vaginal Vault Prolapse Yes ___ No X Yes ___ No X Pre ___ Post ___ Wound Healing Problems If Yes, please explain: Yes ___ No X Yes ___ No X Pre ___ Post ___ Any other disease of the gut, intestines, or bowels If Yes, please specify condition (s): Yes X No ___ Yes X No ___ Pre ___ Post X Testing for enlarged liver and spastic colon 17 Case 2:12-cv-02077 Document 65-1 Filed 07/08/16 Page 14 of 15 PageID #: 321 Case 2:12-cv-02077 Document 65-1 Filed 07/08/16 Page 15 of 15 PageID #: 322 Exhibit B Case 2:12-cv-02077 Document 65-2 Filed 07/08/16 Page 1 of 4 PageID #: 323 Case 2:12-cv-02077 Document 65-2 Filed 07/08/16 Page 2 of 4 PageID #: 324 Case 2:12-cv-02077 Document 65-2 Filed 07/08/16 Page 3 of 4 PageID #: 325 Case 2:12-cv-02077 Document 65-2 Filed 07/08/16 Page 4 of 4 PageID #: 326 Exhibit C Case 2:12-cv-02077 Document 65-3 Filed 07/08/16 Page 1 of 74 PageID #: 327 Case 2:12-cv-02077 Document 65-3 Filed 07/08/16 Page 2 of 74 PageID #: 328 Case 2:12-cv-02077 Document 65-3 Filed 07/08/16 Page 3 of 74 PageID #: 329 Case 2:12-cv-02077 Document 65-3 Filed 07/08/16 Page 4 of 74 PageID #: 330 Case 2:12-cv-02077 Document 65-3 Filed 07/08/16 Page 5 of 74 PageID #: 331 Case 2:12-cv-02077 Document 65-3 Filed 07/08/16 Page 6 of 74 PageID #: 332 Case 2:12-cv-02077 Document 65-3 Filed 07/08/16 Page 7 of 74 PageID #: 333 Case 2:12-cv-02077 Document 65-3 Filed 07/08/16 Page 8 of 74 PageID #: 334 Case 2:12-cv-02077 Document 65-3 Filed 07/08/16 Page 9 of 74 PageID #: 335 Case 2:12-cv-02077 Document 65-3 Filed 07/08/16 Page 10 of 74 PageID #: 336 Case 2:12-cv-02077 Document 65-3 Filed 07/08/16 Page 11 of 74 PageID #: 337 Case 2:12-cv-02077 Document 65-3 Filed 07/08/16 Page 12 of 74 PageID #: 338 Case 2:12-cv-02077 Document 65-3 Filed 07/08/16 Page 13 of 74 PageID #: 339 Case 2:12-cv-02077 Document 65-3 Filed 07/08/16 Page 14 of 74 PageID #: 340 Case 2:12-cv-02077 Document 65-3 Filed 07/08/16 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Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 1 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF WEST VIRGINIA AT CHARLESTON RE: ETHICON, INC., PELVIC ) Master File No. REPAIR SYSTEM PRODUCTS ) 2:12-MD-02327 LIABILITY LITIGATION ) JOSEPH R. GOODWIN ) U.S. DISTRICT JUDGE ______________________________) NATALIE C. MARSHALL, ET AL., ) Case No. ) 2:12-cv-02077 Plaintiffs, ) ) vs. ) ) ETHICON, INC., ET AL., ) ) Defendants. ) ______________________________/ VIDEOTAPED DEPOSITION OF NATALIE C. MARSHALL March 10, 2016 9:04 a.m. to 1:12 p.m. BEST WESTERN MORRISTOWN, TENNESSEE Michele Faconti, RPR, LCR (667) Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 2 of 30 PageID #: 402 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 15 1 A. Yes, ma'am. 2 Q. How soon after having the mesh implant in 3 August of 2007 did you begin to experience pain with 4 intercourse with Mr. Marshall? 5 A. As soon as I could have intercourse, which 6 was within -- it was right at the six-week limit 7 that the doctor gave us. 8 Q. And six weeks after your implant surgery, 9 what did you think was causing you to experience 10 that pain with intercourse? 11 A. I didn't have any idea. 12 Q. Have you ever had pain with intercourse -- 13 A. No. I'm sorry. 14 Q. That's okay. 15 Before you began experiencing pain with 16 intercourse after the mesh -- no, no, no. Strike 17 that. 18 Before your mesh surgery in August of 19 2007, had you ever had pain with intercourse? 20 A. No, ma'am. 21 Q. Are there other -- are there any other 22 physical injuries that you're claiming that you've 23 experienced as a result of having the mesh implant? 24 A. I have a lot of lower back pain that I Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 3 of 30 PageID #: 403 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 29 1 TVT-O? 2 A. No, ma'am. 3 Q. Have you asked any of your healthcare 4 providers whether any infection that you had was 5 caused by the TVT-O? 6 A. No, ma'am. 7 Q. Are you claiming urinary problems from the 8 TVT-O? 9 A. I would not say caused by the TVT-O, but 10 still had some problems after the TVT-O. 11 Q. When did you first start having urinary 12 problems after the TVT-O? 13 A. Almost immediately. 14 Q. What did you think was causing you to 15 experience those urinary problems? 16 A. I just thought that maybe the device was 17 not working right. I mean, that -- that was just -- 18 Q. So you immediately suspected that there 19 was a problem with the device? 20 MR. BOYD: Objection. Form. 21 THE WITNESS: I can't say that it would be 22 that. That would be my -- if I said that, that 23 would just be my opinion. So I can't say. 24 Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 4 of 30 PageID #: 404 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 30 1 BY MS. DANZEY: 2 Q. But was it your opinion that the device 3 was the source of your urinary problems that you 4 experienced immediately after the surgery? 5 A. I would have thought it to be a defect 6 maybe in the device. 7 Q. And when did you first believe or suspect 8 that it was a defect in the device? 9 A. Well, I discussed it with my doctor on my 10 six-week's checkup when I went back after the 11 surgery. 12 Q. And did you continue to suspect that there 13 was a defect in your device after your six-week 14 checkup? 15 A. I just knew I was having problems. 16 Q. Yes, ma'am. That didn't quite answer my 17 question, though. 18 Did you continue to suspect that there was 19 a defect in the device after the six-week checkup? 20 A. Yeah. 21 Q. Okay. And when did you first start having 22 infections after having the mesh implant? 23 A. I can't really specify a time on that. 24 Q. Getting back to the third page. Bowel Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 5 of 30 PageID #: 405 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 60 1 gynecologist? 2 A. I'm seeing Erin Sanders. That's who I go 3 to on a yearly basis now. 4 Q. You told me about seeing Dr. Hatfield -- 5 A. Yes. 6 Q. -- as a urologist? 7 Have you seen any other urologists? 8 A. Just Dr. Bowling. And he's specified as a 9 urogynecologist. 10 And I gave you the wrong. It's Saunders, 11 instead of Sanders. I'm sorry. She practices at 12 Fort Sanders. 13 Q. Ms. Marshall, have you gone through 14 menopause? 15 A. I had a total hysterectomy at 32. 16 Q. And why did you have a hysterectomy at 32? 17 A. It was endometriosis. 18 Q. And what sort of symptoms were you having 19 associated with your endometriosis? 20 A. Goodness. It's been so long, I don't 21 remember. I don't remember. It's been so long. I 22 was 32. 23 Q. Do you remember who performed that total 24 hysterectomy? Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 6 of 30 PageID #: 406 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 61 1 A. I do. It was at Fort Sanders Ob/Gyn, the 2 same clinic where Saunders practices. And her name 3 was Dr. Molly Peeler. She's no longer there. 4 P-e-e-l-e-r. 5 Q. Do you remember talking to Dr. Peeler 6 before having that hysterectomy about the risks 7 associated with having a hysterectomy? 8 A. I remember having a discussion with her 9 about the hysterectomy. No risk factors that I know 10 of were, you know, spoken about. 11 Q. After you had your hysterectomy, did you 12 ever have any problems with intercourse after the 13 hysterectomy? 14 A. Not that I remember. 15 Q. Did you ever experience a dryness of your 16 vaginal mucosa after having the hysterectomy? 17 A. They gave me hormones for 18 years. I 18 took hormones, so... 19 Q. Did you also have a Burch procedure? 20 A. A what? 21 Q. A Burch procedure. 22 A. I don't know what that is. 23 Q. When you had your hysterectomy, do you 24 recall having any other type of operation at that Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 7 of 30 PageID #: 407 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 62 1 time? 2 A. Excuse me. Oh, goodness. At that time 3 when I had my hysterectomy, I believe that she 4 did -- I don't know if it's called a Burch procedure 5 or not. I believe that she did what they called it 6 at that time, what they called a bladder tack. Is 7 that what that is? 8 Q. Yes, ma'am. Why did you have to have a 9 bladder tack at that time? 10 A. At that time -- well, I had had two 11 children and everybody's bladder sort of drops after 12 they've had children and so she -- just while she 13 was in there, she'd just go ahead and tack it up. 14 Q. Do you remember what year you had your 15 hysterectomy and bladder tack? 16 A. I -- I'm sorry. In my mind, I want to 17 think it was 1989. I'm not for sure, but -- 18 Q. I haven't see a record from your 19 hysterectomy, but I have seen just references in 20 your records that it happened in 1989. 21 A. I was thinking '89, uh-huh. 22 Q. Before you had your bladder tack and 23 hysterectomy in 1989, what kind of symptoms were you 24 having, the reason why you had that bladder tack? Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 8 of 30 PageID #: 408 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 63 1 A. I'm sure at that time it was probably 2 incontinence and things that -- like most women do. 3 Q. Do you remember how long you dealt with 4 incontinence before having that bladder tack in 5 1989? 6 A. No, I do not. 7 Q. Do you remember talking with Dr. Peeler 8 about any of the risks associated with having a 9 bladder tack? 10 A. No, ma'am. She had suggested a bladder 11 tack. 12 Q. Before you had your bladder tack in 1989, 13 did you try any other methods of treatment? 14 A. For? 15 Q. For the incontinence that you had been 16 experiencing. 17 A. No. 18 Q. Did the bladder tack eventually fail? 19 MR. BOYD: Objection. Form. 20 THE WITNESS: Evidently. 21 BY MS. DANZEY: 22 Q. Let me ask it a different way. 23 After you had your bladder tack in 1989, 24 was there a time period where you did not deal with Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 9 of 30 PageID #: 409 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 70 1 BY MS. DANZEY: 2 Q. All right. Ms. Marshall, before we took 3 our break I was asking for your best recollection as 4 to when you began experiencing incontinence issues 5 again after your Burch procedure. And you told me 6 your best estimate was maybe it lasted for -- seemed 7 to work for you for about ten years. 8 Do you remember that testimony? 9 A. Yes. 10 Q. And I understand that was your best 11 estimate. I have some records here that maybe will 12 help refresh your recollection. 13 A. Okay. 14 (Exhibit No. 7 marked.) 15 BY MS. DANZEY: 16 Q. I'll hand you what's been marked as 17 Deposition Exhibit No. 7. And you'll see at the top 18 of this record it's dated April 9th of 1997. Do you 19 see that? 20 A. Yes. 21 Q. And if you'll turn to the second page, the 22 third question says, "Do you have bladder problems? 23 If so, please describe," and it says, "Occasional 24 stress incontinence." Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 10 of 30 PageID #: 410 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 71 1 Did I read that correctly? 2 A. Yes. 3 Q. And if you'll keep going further down, it 4 says, "Do you have urine leakage at rest?" And it 5 says "no." "When coughing, laughing or climbing 6 stairs?" And then it says "coughing." 7 Do you see that? 8 A. Yes. 9 Q. Do you remember having incontinence issues 10 in April of 1997? 11 A. I couldn't specify that date. I mean, I 12 know that I had some stress incontinence when I 13 coughed, but I don't -- I don't recall the date. 14 Q. Do you recall only experiencing 15 incontinence when you coughed, is that the only 16 activity? 17 A. I guess at this time, that's all I put 18 down there. 19 Q. Okay. 20 A. Yeah. So that's -- that would be all I 21 would remember is what's on the paper. 22 Q. Aside from seeing this record, do you have 23 an independent recollection of experiencing 24 incontinence in April of 1997? Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 11 of 30 PageID #: 411 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 72 1 A. I do not. 2 Q. If you'll turn to the first page of this 3 record. To the right of the page, the sixth 4 question, it says, "Do you have a vaginal 5 discharge?" And the answer is "no." 6 Do you see that? 7 A. Yes. 8 Q. And then beside that it says, "Pain during 9 intercourse?" And it says "Occasion," O-c-c-a-s, 10 which I think means "occasionally." 11 Do you see that? 12 A. Yes. 13 Q. Do you recall having pain during 14 intercourse in April of 1997? 15 A. I do not. I don't remember at that time 16 having -- having any pain during intercourse during 17 that time. I do not. 18 Q. Do you have any reason to dispute this 19 record? 20 A. Just the fact that I don't remember. And 21 that's April of '97. 22 Q. Okay. I understand you don't remember it. 23 But my question is, do you have any reason to 24 dispute the record? Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 12 of 30 PageID #: 412 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 73 1 A. To dispute what I put on there. 2 Q. No, you don't have a reason, correct? 3 You have to answer out loud, Ms. Marshall. 4 A. I'm sorry. 5 Q. You're shaking your head. 6 A. I'm sorry, I'm looking at the paper. 7 Q. That's okay. I'll start over. 8 Do you have any reason to dispute this 9 record? 10 A. Not with what I put at that time, no. 11 (Exhibit No. 8 marked.) 12 BY MS. DANZEY: 13 Q. I'm showing you what's marked as 14 Deposition Exhibit No. 8. And you'll see at the top 15 this record is dated March 25th of 1999? 16 A. Uh-huh. 17 Q. If you'll go about midway where it says 18 "ROS," which I think is review of symptoms, do you 19 see that? 20 A. Yes. 21 Q. It says, "Significant for chronic stress 22 urinary incontinence." 23 Did I read that correctly? 24 A. Yes. Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 13 of 30 PageID #: 413 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 74 1 Q. Do you remember having complaints of 2 significant chronic stress urinary incontinence in 3 March of 1999? 4 A. I don't know what he means by 5 "significant." So that's his words, not mine. 6 Q. Do you remember having issues with stress 7 urinary incontinence at all in March of 1999? 8 A. I don't remember the date. But -- 9 possibly, though. I mean, I -- 10 Q. I understand that maybe you don't remember 11 the date. 12 A. Yeah, I don't remember the date. 13 Q. Do you have any reason to dispute this 14 record? 15 A. No, I do not. 16 (Exhibit No. 9 marked.) 17 BY MS. DANZEY: 18 Q. I'm handing you what's been marked as 19 Deposition Exhibit No. 9. And you'll see at the top 20 left this record is dated February 10th of 2000. 21 After the date if you will go down 22 -- two, three, four -- six lines where it says 23 "C/O," it says, "Having a lot of abdominal pressure. 24 Has leakage with coughing." Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 14 of 30 PageID #: 414 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 75 1 Do you remember having abdominal pressure 2 in February of 2000? 3 A. I don't know what that means. I don't 4 know what the "abdominal pressure" means. I 5 understand the leakage and the coughing, but what 6 they mean by "abdominal pressure," I don't know what 7 they mean. 8 Q. You don't ever recall having -- having 9 symptoms of feeling some abdominal pressure? 10 A. I don't know what they mean by that. 11 Q. Okay. Just asking you, do you remember 12 ever having any -- 13 A. No. 14 Q. You have to let me get my question out, 15 though. 16 A. Sorry. 17 Q. Do you ever remember having felt some 18 pressure in your abdominal area? 19 A. Not that I -- not that I recollect. 20 Q. You don't remember? That's okay. 21 All right. Do you remember having issues 22 with leaking with coughing in February of 2000? 23 A. I don't know about February of 2000, but I 24 know in that area, I'm sure that would be a time Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 15 of 30 PageID #: 415 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 76 1 frame. 2 (Exhibit No. 10 marked.) 3 BY MS. DANZEY: 4 Q. Staple error. 5 I'm showing you what's been marked as 6 Deposition Exhibit No. 10. And you'll see at the 7 top left, this record has been dated April 30th, 8 2003. 9 Do you see that? 10 A. Yes. 11 Q. And underneath the date, one, two, three 12 lines down it says, "Having some stress 13 incontinence." 14 Do you remember having issues with stress 15 incontinence as of April 2003? 16 A. Again, I don't remember the date, but -- 17 but I know I was having stress incontinence all 18 during that time, yes. 19 Q. So far we have looked at records from 20 1997, 1999, 2000, and now 2003. Do you remember 21 whether your stress incontinence symptoms progressed 22 over time or did they -- strike that. 23 Do you remember whether your stress 24 incontinence progressed over time? Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 16 of 30 PageID #: 416 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 77 1 A. It got worse over time, is that what 2 you're asking? 3 Q. Yes, ma'am. 4 A. Yes, ma'am. 5 Q. Okay. Explain to me how it got worse over 6 time. 7 A. In other words, stress continence, the way 8 I understand it, there is a stress causing it, 9 either coughing, sneezing, things like that, 10 bending, different things would be your stress 11 incontinence. In other words, it would start out 12 just when I coughed, things like that. Then later 13 maybe when I would bend down to pick something up. 14 So different things would cause it other than just 15 the coughing. So that's how it would progress. 16 Maybe more frequently. 17 Q. At the bottom of this record, it's dated 18 May 15th of 2003. 19 Do you see that? 20 A. Yes. 21 Q. And underneath that date, one, two lines 22 in, it says, "Stress incontinence, cough, leak." In 23 parentheses it says, "History of bladder 24 suspension," and then it says, "Use bladder guard." Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 17 of 30 PageID #: 417 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 78 1 Did I read that correctly? 2 A. Yes. 3 Q. Do you remember using a bladder guard? 4 A. Bladder guard just means something like a 5 pad that you wear, uh-huh. 6 Q. How often do you think you were wearing 7 pads to deal with your incontinence? 8 A. It was daily. Constantly. 9 Q. And how many pads did you go through per 10 day? 11 A. Different days were different. I don't 12 know. Three, four maybe. And not the same amount 13 every day. 14 Q. If you will turn to the second page of 15 this record. You'll see that it's dated April 30th 16 of 2003. If you will go down under ROS, review of 17 symptoms, you see that? 18 A. Under -- under what? 19 Q. ROS. 20 A. Okay. 21 Q. You see that? 22 A. Yes. 23 Q. About the third line under review of 24 symptoms, it says, "Stress incontinence. She Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 18 of 30 PageID #: 418 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 79 1 reports when she coughs, she will leak a little bit. 2 First thing in the morning she has to go 3 immediately. She does wear bladder protection pads 4 at all times. Her leakage is more than what a maxi 5 pad would hold, and she needs a true incontinence 6 product." 7 Did I read that correctly? 8 A. Yes, ma'am. 9 Q. Do you remember any of your doctors 10 recommending an incontinence product at that time in 11 2003? 12 A. No, they never recommended anything. 13 Q. If you go further down on the same page, 14 it's one, two, three -- about four lines up from the 15 bottom, the first word in this sentence is "Zyrtec." 16 Do you see that? 17 A. Yes. 18 Q. And go to the end of that sentence, it 19 says, "Stress incontinence stable on Detrol," if I'm 20 pronouncing that correctly. 21 Do you know what Detrol is? 22 A. I do. 23 Q. Okay. What is Detrol, Ms. Marshall? 24 A. It is a pill that they often use for Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 19 of 30 PageID #: 419 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 80 1 stress -- well, for stress incontinence. But when 2 they recommended that, it helped, but I couldn't 3 take it. 4 Q. Did you ever try to take Detrol? 5 A. I -- I did. 6 Q. How long did you try it? 7 A. I just took it for a very short period of 8 time. I don't know, maybe a week or two. And it 9 did help with the stress incontinence. 10 Q. But it's your testimony that you could not 11 take it? 12 A. Yeah. Just completely dries you out. 13 Q. When you say it dries you out, what does 14 that mean? 15 A. Your mouth, everything. Just totally dry. 16 Q. After about two weeks you stopped taking 17 the Detrol; is that correct? 18 A. I'm not sure it was that long. 19 Q. Did you try any other medications to help 20 with your stress urinary incontinence? 21 A. Not that I remember. 22 (Exhibit No. 11 marked.) 23 BY MS. DANZEY: 24 Q. Aside from the issues that you were having Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 20 of 30 PageID #: 420 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 81 1 with stress urinary incontinence where you leaked 2 with coughing or bending or certain activities, did 3 you also have -- did you also experience frequent 4 urination? 5 A. At times. 6 Q. Do you remember when that started? 7 A. I do not. 8 Q. Were there ever times where you didn't get 9 to the bathroom soon enough? 10 A. Not that I remember. 11 Q. If I'm understanding you then, aside from 12 wearing the pads, you don't have any recollection of 13 completely wetting yourself; is that right? 14 A. No, because I always had the pads. 15 Q. During the time that you were experiencing 16 this stress urinary incontinence for the second 17 time, after having had the bladder tuck or bladder 18 tack, were you ever embarrassed about this 19 condition? 20 A. About the urinary incontinence? 21 Q. Yes, ma'am. 22 A. I do remember one time. 23 Q. What happened during that one time? 24 A. I don't remember a timeline on it, but I Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 21 of 30 PageID #: 421 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 82 1 specifically remember this time. It was like a 2 church gathering at my brother-in-law's house. And 3 that was embarrassing, I guess, because it was all 4 the people I go to church with and we were all 5 playing baseball in the backyard. And when I 6 would -- when I ran to one of the bases, and it's 7 the only time I ever know that to happen, but when I 8 ran to one of the bases, I had bladder leakage and 9 my clothes were totally wet. And that's the only 10 time I remember because that that -- that happened. 11 And I remembered it because it was an embarrassing 12 time. 13 Q. Before you had your mesh surgery, did you 14 have issues making a bowel movement? 15 A. I would say maybe occasionally 16 constipation, you know. 17 Q. Prior to having your mesh surgery in 18 August of 2007, did your stress urinary incontinence 19 issues ever prevent you from having -- strike that. 20 Prior to your mesh surgery, did your 21 stress urinary incontinence have any impact on your 22 sexual relationship with Mr. Marshall? 23 A. Most definitely. 24 Q. How did it impact your relationship with Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 22 of 30 PageID #: 422 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 83 1 him? 2 A. I guess the pressure of the intercourse 3 would cause me to have bladder leakage. 4 Q. And you would leak during intercourse? 5 A. Yes. 6 Q. Do you remember when that started? 7 A. I do not. 8 Q. Prior to you having the mesh surgery in 9 August of 2007, how often did you and Mr. Marshall 10 have sexual intercourse? 11 A. And you're saying prior to the mesh 12 surgery? 13 Q. Yes, ma'am. Before the mesh surgery. 14 A. Not often. 15 Q. Remember I told you I have to ask you 16 these questions. 17 When you say "not often," give me your 18 best estimate. Did you all have sex once a week, 19 once every other week? 20 A. Maybe once a month. 21 Q. And do you recall how long you and Mr. 22 Marshall had been limiting yourselves to sex once a 23 month? 24 A. Ask me that one more time. Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 23 of 30 PageID #: 423 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 84 1 Q. I'm trying to get an understanding of how 2 often you and Mr. Marshall were having sex just once 3 a month. 4 A. How long did that go on? 5 Q. Yes, ma'am. Before the mesh surgery. 6 A. I would say, and this is only an estimate, 7 I would estimate two or three years. 8 Q. Were you refraining from having sexual 9 intercourse more frequently due to your urinary 10 incontinence issues? 11 A. At that point, yes. 12 Q. Were there any other reasons why you and 13 Mr. Marshall were only having intercourse once a 14 month? 15 A. No. 16 Q. I'm handing you what's been marked as 17 Deposition Exhibit No. 11. And you'll see at the 18 top right it's dated August 1st of 2007? 19 A. Yeah. 20 Q. Well, actually go to the second page. And 21 you'll see at the bottom that it was dictated on 22 July 27th of 2007, so that's more than likely the 23 date that you saw this physician. 24 Do you see that? Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 24 of 30 PageID #: 424 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 85 1 A. Yes. 2 Q. July 27th, 2007, at the bottom of page 3 two. 4 All right. Go to page one and I'll read 5 just a bit of this: "Patient is a 50-year-old white 6 female with several years of right abdominal pain 7 penetrating to the back," and I'll butcher this, 8 "subscapular area. This has worsened over the last 9 four to six weeks." I'll stop there. 10 Do you remember having abdominal pain 11 prior to having your mesh surgery? 12 A. Well, on the right abdominal pain, yes. 13 Q. "She has some associated reflux symptoms 14 that are distinctly different." And I'll skip just 15 a bit. 16 "Secondary to those findings, she is seen 17 for laparoscopic and possible open," I'll butcher 18 this, "cholecystectomy. I discussed the operation 19 with the patient, including potential for blood 20 loss, infection, injury to bowel or bile duct, 21 possibility of open operation and requirement of 22 general anesthesia. She is additionally adding a 23 continence procedure with Dr. Bruce Fariss, and I 24 have no reason this cannot be combined. I have Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 25 of 30 PageID #: 425 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 86 1 discussed cholecystectomy with patient, including 2 potential for blood loss, infection, injury to bile 3 -- "to bowel," excuse me, "or bile duct, possibility 4 of open operation and requirement for general 5 anesthetic, possibility that her symptoms may not be 6 related to gallbladder. She expresses 7 understanding." 8 Did I read that correctly? 9 A. Yes, ma'am. 10 Q. I know you have clarified that you were 11 having abdominal pain on the right. How often were 12 you experiencing that abdominal pain? 13 A. Frequently. Nearly on a daily basis. 14 Q. And on a scale of one to ten, with one 15 being very little pain, and ten being excruciating 16 pain, how much pain -- how would you rate the pain 17 that you had before you had your surgery? 18 A. Seven to eight. 19 Q. And for how long do you think you had 20 abdominal pain that was seven to eight on a scale of 21 ten? 22 A. I know it was months. I just don't 23 remember how much. 24 Q. According to this record you -- by Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 26 of 30 PageID #: 426 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 92 1 a medication and the use of pads? 2 A. I -- I don't know why I didn't ask. I 3 just didn't ask him. 4 Q. When Dr. Fariss recommended that you have 5 surgery with a mesh product during that first visit, 6 did you agree to have the surgery at that time? 7 A. I think so, yes. 8 Q. Did you consult with Mr. David? 9 A. No, I make up my own mind. 10 Q. Is the sole reason you agreed to have the 11 TVT product implanted in you was based on Dr. 12 Fariss's recommendation? 13 A. Well, the reason was for the incontinence, 14 but I used him on account of the recommendation. 15 Q. Yes, ma'am. Did you rely on any other 16 person to agree to have the TVT surgery? 17 A. No. 18 Q. Did you rely on any other outside 19 information in agreeing to have the TVT surgery? 20 A. Not that I remember. 21 Q. If I'm understanding your testimony, you 22 solely relied on Dr. Fariss's recommendation to have 23 the TVT, correct? 24 A. Yes. Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 27 of 30 PageID #: 427 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 95 1 BY MS. DANZEY: 2 Q. Is it your testimony that you don't recall 3 discussing any risks, or is it your testimony that 4 Dr. Fariss did not discuss any risks with you? 5 A. As far as I can remember, he did not 6 discuss any risks with me. 7 (Exhibit No. 12 marked.) 8 BY MS. DANZEY: 9 Q. All right. Ms. Marshall, I'm handing you 10 what's been marked as Deposition Exhibit No. 12. 11 You see this is an Informed Consent for Surgery, 12 I'll read pieces of it. "Name of patient, Natalie 13 Marshall. 14 Number one, "I, hereby request and 15 authorize Dr. Fariss and/or such assistants as may 16 by selected by him, to treat the condition or 17 conditions which appear below. The nature of my 18 condition is leakage." 19 Number two, "The procedures necessary to 20 be performed have been explained to me by Dr. 21 Fariss, and I understand the nature of the procedure 22 to be bladder sling." 23 Number four, "It has been explained to me 24 that during the course of operation, unforeseen Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 28 of 30 PageID #: 428 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 96 1 conditions may require additional surgery 2 immediately. If I need surgery" -- "If I need such 3 additional surgery during my operation, I permit Dr. 4 Fariss, his assistants or his designee to perform 5 such medical/surgical procedures as necessary. 6 Number five, "Dr. Fariss has discussed and 7 explained to me the nature and purpose of the 8 operation or procedure, the possibility that 9 complications may develop, significant risks, 10 available alternative methods of treatment, benefits 11 and side effects related to alternatives, including 12 the possible results of not receiving care, 13 treatment and services. I've had the opportunity to 14 ask questions and my questions have been answered." 15 Number seven, "I understand that no 16 guarantees have been made to me according" -- strike 17 that. 18 "I understand that no guarantees have been 19 made to me concerning the risks or results of this 20 procedure." 21 And, number nine, "I certify that I have 22 read and fully understand the above information." 23 Did I read those sections correctly? 24 A. You did. Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 29 of 30 PageID #: 429 Natalie C. Marshall Golkow Technologies, Inc. - 1.877.370.DEPS Page 97 1 Q. And then there is a signature here. Is 2 that your signature, Ms. Marshall? 3 A. Yes, it is. 4 Q. Did you voluntarily sign this consent 5 form? 6 A. I did. 7 (Exhibit No. 13 marked.) 8 BY MS. DANZEY: 9 Q. I'll show you what's been marked as 10 Deposition Exhibit No. 13. And you'll see this is 11 the operative report. It's dated August 1st, 2007. 12 And it says, "Pre-operative diagnosis: Stress 13 urinary incontinence. Procedure: TVT obturator 14 technique." And the surgeon is Dr. Fariss. 15 What do you recall about your TVT surgery? 16 A. I just remember going to the hospital that 17 morning and having it done. And -- and leaving 18 afterward. 19 Q. Did anybody go with you to the hospital 20 for the operation? 21 A. My husband was with me, David. 22 Q. Mr. Marshall was with you? 23 A. Yes. 24 Q. And do you recall how long your procedure Case 2:12-cv-02077 Document 65-4 Filed 07/08/16 Page 30 of 30 PageID #: 430 Exhibit E Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 1 of 28 PageID #: 431 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 1 1 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA 2 AT CHARLESTON 3 -------------------------------- § IN RE: ETHICON, INC., PELVIC § 4 REPAIR SYSTEM PRODUCTS LIABILITY § Master File LITIGATION § No. 2:12-MD-02327 5 § THIS DOCUMENT RELATES TO: § MDL NO. 02327 6 -------------------------------- § § 7 Natalie C. Marshall, et al., v. § JOSEPH R. GOODWIN Ethicon, Inc., et al. § U.S. DISTRICT JUDGE 8 § Case No. 2:12-cv-02077 § 9 § -------------------------------- § 10 11 - - - 12 Wednesday, June 22, 2016 13 - - - 14 15 Videotaped deposition of BRUCE LINDSAY FARISS,JR, M.D. held at Key West Marriott Beachside, 3840 North 16 Roosevelt Boulevard, Key West, Florida 33040, commencing at 1:00 p.m., on the above date, 17 before Susan D. Wasilewski, Registered Professional Reporter, Certified Realtime 18 Reporter, Certified Realtime Captioner, Certified Manager of Reporting Services, Florida 19 Professional Reporter, Certified Court Reporter (New Jersey), and Realtime Systems Administrator 20 21 - - - 22 GOLKOW TECHNOLOGIES, INC. 877.370.3377 ph | 917.591.5672 fax 23 deps@golkow.com 24 Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 2 of 28 PageID #: 432 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 32 1 give it to you. 2 A. Okay. 3 MR. MORIARTY: That's just the one copy. 4 MR. KRUKA: Okay. 5 Q. And I'll direct you to certain pages that I 6 want to ask you about. Oh, I'm sorry. Can I have 7 that back, please? 8 A. Yes, of course. 9 Q. I need to mark it. 10 THE WITNESS: Could we loosen this just a 11 little bit, so when I lean forwards it's not 12 tugging? 13 MR. MORIARTY: Why don't we go off the 14 record. 15 THE VIDEOGRAPHER: The time is approximately 16 1:34 p.m. and we're going off the video record. 17 (Recess from 1:34 p.m. until 1:36 p.m.) 18 THE VIDEOGRAPHER: The time is approximately 19 1:36 p.m. and we're back on the video record. 20 BY MR. MORIARTY: 21 Q. Doctor, I want to hand you what I've marked 22 as Exhibit 10. 23 A. Thank you. 24 (Fariss Exhibit 10 was marked for Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 3 of 28 PageID #: 433 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 33 1 identification.) 2 Q. Is that the chart that was sent to you and 3 that you had an opportunity to review before today? 4 A. Yes, it is. 5 Q. Okay. I'd like you to go to page 9, please. 6 By the way, do you recognize this as a medical chart 7 from the St. Mary's Medical Center? 8 A. Yes, sir. 9 Q. Did you have privileges there? 10 A. Yes, I did. 11 Q. Okay. So page 9 should be a presurgical 12 history and physical. Is that the document you see 13 there? 14 A. Yes, sir. 15 Q. And tell the jury in general what a history 16 and physical form is. 17 A. It's an opportunity for the medical 18 practitioner to become familiar with the patient's 19 medical condition, previous surgical and medical 20 therapies. 21 Q. Does it have a listing of the patient's 22 history, what they complain about? 23 A. Yes, it is. 24 Q. And then a list of medications, previous Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 4 of 28 PageID #: 434 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 34 1 surgeries, things of that nature? 2 A. Yes, sir. 3 Q. And then they ask the patient questions in a 4 review of systems, and then do a physical exam? 5 A. That's correct. 6 Q. And that's all documented on this sheet? 7 A. Yes, sir. 8 Q. Okay. In the middle of the first paragraph 9 under History, is there a section where Dr. Garber, 10 who dictated this note, says that he discussed the 11 operation with the patient, including the potential 12 for, and then he lists various complications, do you 13 see that? 14 A. Yes, that's correct. 15 Q. Including blood loss, infection, injury to 16 bowel or bile duct, possibility of open operation, 17 et cetera, correct? 18 A. That's correct. 19 Q. And then it refers to you performing a 20 continence procedure; is that right? 21 A. That's correct. 22 Q. Does that refer to the TVTO procedure that 23 you planned to do? 24 A. Yes, it does. Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 5 of 28 PageID #: 435 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 36 1 A. It does. 2 Q. What's the date for that? 3 A. July 30th, 2007. 4 Q. Is that an indication that most likely you 5 saw her in the days leading up to the hospitalization? 6 A. That's correct. 7 Q. Okay. And the chief complaint here was 8 incontinence; is that correct? 9 A. That's correct. 10 Q. And then on page 12 you list the procedure 11 that you plan to perform and you signed this form, 12 correct? 13 A. That's correct. 14 Q. Now, before I get to the operative note, I 15 want to hand you what I've had marked as Exhibit 7. 16 (Fariss Exhibit 7 was marked for 17 identification.) 18 Q. And I will tell you that this is a chart that 19 the lawyers drew up. It is a list of potential risks 20 of nonmesh stress urinary incontinence surgery. Okay? 21 Do you see that on this chart? 22 A. I do. 23 Q. And from what you've told us before, do you 24 have extensive experience in performing nonmesh SUI Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 6 of 28 PageID #: 436 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 37 1 surgery? 2 A. That's correct. 3 Q. Take a look over this list, just the first 4 page of this exhibit. Do you agree that those are at 5 least potential risks and complications of a nonmesh 6 surgery, like a Burch or an MMK? 7 A. Yes. 8 Q. Or a pubovaginal sling of some type? 9 A. That's correct. 10 Q. Okay. Now I'd like you to go to the second 11 page of that exhibit. Do you see that in the left 12 column is the same risks that appeared on the first 13 page of the exhibit? 14 A. Yes, I do. 15 Q. But this time they are compared up against 16 the potential risks and complications of a mesh 17 surgery; is that correct? 18 A. That's correct. 19 Q. Before you took Mrs. Marshall to the 20 operating room in August of 2007, did you know that 21 these were potential risks and complications of the 22 TVTO procedure that you were going to perform? 23 A. Can you repeat the question? 24 Q. Sure. Before you took Mrs. Marshall to the Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 7 of 28 PageID #: 437 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 38 1 operating room in August of 2007, were you aware that 2 these were potential risks and complications of the 3 SUI procedure that you intended to perform? 4 A. Yes, of all of the procedures that I would 5 perform. 6 Q. Okay. And on the list on the right is -- 7 should be exposure or erosion of the mesh itself. 8 It's the second to last line: "Erosion/Exposure/ 9 Extrusion" of mesh. Do you see that? 10 A. I do. 11 Q. Were you aware that that was a potential risk 12 and complication of a TVTO procedure? 13 A. Yes. 14 Q. Were you aware of that back in 2007? 15 A. Yes. 16 Q. Were you aware that the procedure might not 17 work as intended and that Mrs. Marshall could get a 18 recurrence of her SUI? 19 A. Yes. 20 Q. And you were aware that she could get pain or 21 pain with sexual intercourse as a potential risk and 22 complication; is that correct? 23 A. With any surgical procedure to treat 24 incontinence. Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 8 of 28 PageID #: 438 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 39 1 Q. All right. Did you know, Doctor, back in 2 2007, that some of these risks could be either mild, 3 moderate, or severe? 4 A. I could say that about any medical condition. 5 Q. Okay. And could they be temporary or 6 permanent? 7 A. Yes. 8 Q. Now, let's go back to what we've learned from 9 the records so far regarding Mrs. Marshall. If she 10 did in fact have a hysterectomy, is that a surgery 11 that has the potential to cause pain, including pain 12 on sexual intercourse? 13 A. Yes, it is. 14 Q. Is a Burch a procedure that has the potential 15 to cause pain, including pain on sexual intercourse? 16 A. Yes, it is. 17 Q. Okay. Now, in your experience, Dr. Fariss, 18 is SUI a condition that can impact a woman's quality 19 of life? 20 A. Yes, it is. 21 Q. How does it do that? 22 A. It could do it in many ways. It could affect 23 them physically, recurrent urinary tract infections 24 and pain, a breakdown of skin, as well as emotional, Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 9 of 28 PageID #: 439 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 44 1 A. That's correct. 2 Q. Okay. Have you ever read these documents 3 before? 4 A. I have. 5 Q. Prior to Mrs. Marshall's procedure back in 6 2007, had you read the TVTO IFU? 7 A. I'm sure I had. 8 Q. Doctor, did you rely just on this document in 9 formulating your treatment plan and what you were 10 going to talk about with Mrs. Marshall before the 11 surgery that you performed? 12 A. I did not. 13 Q. What other sort of things did you rely on? 14 A. Well, there would have been a variety of 15 things: My personal experience with the various 16 procedures, as well as use of this device on other 17 patients, CME, and observing other physicians perform 18 these surgical procedures, as well as articles in the 19 journals. 20 I know I specifically went to a urinary 21 continence program which was a week long around that 22 time frame. 23 Q. Where was that conference? 24 A. That was in St. Thomas. Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 10 of 28 PageID #: 440 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 45 1 Q. Do you know who sponsored it? 2 A. No. 3 Q. Do you think you relied on this document at 4 all in making your decision about whether to operate 5 on Mrs. Marshall? 6 A. I don't know that I relied on it at all. 7 It's just in addition to my basic knowledge. 8 Q. Okay. So tell us all -- well, first of all, 9 take a look at that medical record at page 53. Are 10 you there? 11 A. Yes, I am. 12 Q. Tell us what that is. 13 A. This is an informed consent for the 14 cholecystectomy. 15 Q. Is that the procedure that Dr. Garber did? 16 A. That's correct. 17 Q. Is that an abdominal procedure? 18 A. Yes, it is. 19 Q. Did he do this one through a laparoscope? 20 A. Yes. 21 Q. So on this day she had an abdominal procedure 22 through a laparoscope and then the procedure that you 23 performed through the vagina, correct? 24 A. That is correct. Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 11 of 28 PageID #: 441 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 46 1 Q. Okay. So go to the next page, 54. Is this 2 the informed consent document for the TVTO procedure 3 that you performed? 4 A. Yes, it is. 5 Q. And this has your name and her name and it's 6 a form that the hospital provides to acknowledge that 7 you've had a discussion with Mrs. Marshall about 8 risks, correct? 9 A. That's correct. 10 Q. Tell us all what your habit, routine and 11 practice was insofar as explaining the risks of a TVTO 12 to a patient like Mrs. Marshall. 13 A. Predominantly, when I see these women, I'm 14 focusing on the potential for a failure of the 15 procedure, as well as you might say overutilization 16 of the procedure, where they develop urinary 17 retention because it is too tight. I always discuss 18 with them the fact that they may have some leg pain 19 for a day or two, so that they are aware of that and 20 they expect that. 21 I let patients know that they may have a 22 small amount of bleeding, and I routinely let them 23 know that 10 days out they may have a very small 24 amount of bleeding as the sutures begin to erode, so Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 12 of 28 PageID #: 442 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 47 1 they don't become concerned when they see a little 2 bleeding 10 days, two weeks out. 3 I let the women know they may have a 4 urinary tract infection in the postoperative time 5 frame and I commonly will give them a prescription 6 for an antibiotic to have available if that should 7 happen. 8 Q. Are you done with your answer? 9 A. Yes, I am. 10 Q. Okay. Would you typically explain to a woman 11 like Mrs. Marshall that she could have pain in her 12 vagina or pain on sexual intercourse? 13 A. No, I wouldn't routinely go over that. 14 Q. Why not? 15 A. Because it's such an infrequent occurrence. 16 Q. And is, in your experience, is vaginal pain 17 and dyspareunia an infrequent occurrence with a TVTO 18 procedure? 19 A. It is one of the reasons why I switched to 20 that type of procedure. 21 Q. Finish your answer and then we're going to go 22 off the record. 23 A. It was one of the reasons why I switched to 24 that type of procedure, because I felt it was less Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 13 of 28 PageID #: 443 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 48 1 likely to occur. 2 Q. And in your experience, has that been true? 3 A. Yes, it has. 4 MR. MORIARTY: Okay. Let's go off the record 5 for a second. 6 THE VIDEOGRAPHER: The time is approximately 7 1:57 p.m. We're going off the video record. 8 (Recess from 1:57 p.m. till 1:59 p.m.) 9 THE VIDEOGRAPHER: The time is 1:58 -- excuse 10 me, 1:59 p.m. We're back on the video record. 11 BY MR. MORIARTY: 12 Q. Doctor, now I'd like you -- we were talking 13 about risks that you likely would have explained to 14 her. 15 Are there any other potential risks and 16 complications that you'd likely explain to a patient 17 under these circumstances, such as injury to adjacent 18 organs or anything else? 19 A. I wouldn't routinely go through that. I 20 would discuss urinary retention and the failure of 21 the procedure. 22 (Fariss Exhibit 12 was marked for 23 identification.) 24 Q. Okay. So I'm going to hand you Exhibit 12, Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 14 of 28 PageID #: 444 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 51 1 MR. MORIARTY: Okay. Go off the record just 2 for a second. I want to organize my notes and I 3 think I'm almost done asking them. 4 THE VIDEOGRAPHER: The time is approximately 5 2:03 p.m. We're going off the video record. 6 (Recess from 2:03 p.m. till 2:05 p.m.) 7 THE VIDEOGRAPHER: The time is approximately 8 2:05 p.m. We're back on the video record. 9 (Fariss Exhibit 13 was marked for 10 identification.) 11 BY MR. MORIARTY: 12 Q. I'm handing you what I've had marked as 13 Exhibit 13. Are you still a member of the AUA? 14 A. Yes, I am. 15 Q. Have you ever seen this position statement 16 before? 17 A. Yes, I have. 18 Q. Doctor, I want to ask you a couple questions 19 about -- I want to ask you some questions about 20 certain statements and ask if you agree. 21 Suburethral synthetic polypropylene mesh 22 sling placement is the most common surgery currently 23 performed for SUI. 24 Is that true? Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 15 of 28 PageID #: 445 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 52 1 A. Yes, sir. 2 Q. Extensive data exists to support the use of 3 synthetic polypropylene mesh suburethral slings for 4 the treatment of female SUI with minimal morbidity 5 compared with alternative surgeries. 6 Do you agree with that? 7 A. Absolutely. 8 Q. Have you read extensive data that fits that 9 description? 10 A. I have. 11 Q. Advantages include shorter operating time, 12 anesthetic need, reduced surgical pain, reduced 13 hospitalization, and reduced voiding dysfunction. 14 Do you agree with that? 15 A. I do. 16 Q. Is that true, in your experience? 17 A. Absolutely. 18 Q. Mesh-related complications can occur 19 following polypropylene sling placement but the rate 20 of these complications is acceptably low. 21 Do you agree with that? 22 A. That's correct. 23 Q. Is it true in your experience? 24 A. Exceedingly low. Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 16 of 28 PageID #: 446 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 53 1 Q. Furthermore, it is important to recognize 2 that many sling-related complications are not unique 3 to mesh surgeries and are known to occur with nonmesh 4 sling procedures as well. 5 Is that true? 6 A. I saw quite a few with nonmesh procedures. 7 Q. Could you just take a look at this position 8 statement, quickly just scan it to refresh your memory 9 about it. I don't mean to cut your reading short -- 10 A. Yes. 11 Q. -- but do you generally agree with the AUA's 12 position statement that I've had handed you and had 13 marked as an exhibit? 14 A. I do. 15 Q. Are you a surgeon who has undergone rigorous 16 training in the principles of pelvic anatomy and 17 pelvic surgery? 18 A. I have in the past. 19 Q. Have you been properly trained in how to 20 perform TVTO procedures? 21 A. Yes, I have. 22 Q. Have you been able to recognize and manage 23 complications associated with SUI surgery, including 24 sling placement when they occur? Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 17 of 28 PageID #: 447 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 54 1 A. Yes, I have. 2 MR. MORIARTY: Doctor, I don't have any other 3 questions for you right now. Plaintiff's counsel 4 will have some and I'm going to reserve the rest 5 of my time in case I need to follow up with you 6 later. 7 THE WITNESS: Okay. 8 THE VIDEOGRAPHER: Go off the record, sir? 9 MR. KRUKA: Please. 10 THE VIDEOGRAPHER: The time is approximately 11 2:08 p.m. We're going off the video record. 12 (Recess from 2:08 p.m. till 2:15 p.m.) 13 THE VIDEOGRAPHER: The time is approximately 14 2:15 p.m. and we're on the video record. This is 15 Tape 2 with Bruce Fariss. 16 CROSS-EXAMINATION 17 BY MR. KRUKA: 18 Q. Good afternoon, Dr. Fariss. My name is Scott 19 Kruka and I introduced myself to you earlier, before 20 we began your deposition today. I represent Natalie 21 Marshall, who was your patient. 22 A. Yes, sir. 23 Q. And you have not had any contact with me 24 before, nor anyone from my law firm, nor anyone Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 18 of 28 PageID #: 448 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 74 1 product, the TVTO and your role as a surgeon, you were 2 familiar with the IFU, which is Exhibit 11? 3 A. That's correct. 4 Q. And at some point in time you read it? 5 A. At some point in time, yes. 6 Q. And would it be fair to say that you relied 7 on the IFU, in part, among other things, to become 8 aware of the risks specific to this procedure and this 9 device? 10 A. In very small part. 11 Q. And why do you say small part? 12 A. Well, there -- yeah. To complete my medical 13 education, I rely on a variety of sources. 14 Q. Okay. Can I turn your attention to that 15 Exhibit 11? Do you need another copy of it? 16 A. I don't have 11 here. 17 Q. Let me give you this. This is a copy of 18 Exhibit 11. I'm going to point your attention to the 19 last page of that document under the heading "Adverse 20 Reactions," under the second bullet point. Are you 21 with me? 22 A. Yes. 23 Q. Can you read that into the record for us? 24 A. "Transitory local irritation at the wound Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 19 of 28 PageID #: 449 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 81 1 Q. Okay. I want to ask you about a list of 2 risks which may be associated with the TVT Obturator 3 and ask if you are familiar with them. 4 A. Uh-huh. 5 Q. Shrinkage of the polypropylene mesh? 6 A. I have not personally seen that. 7 Q. Are you aware that it is a risk? 8 A. I'm not sure that I know that that is a risk. 9 There could be shrinkage of the tissue surrounding 10 the mesh, not necessarily the mesh. 11 Q. And have you seen literature on the 12 percentage of shrinkage that has been recorded, 13 whether it's the mesh or the tissue and the mesh 14 combined? 15 A. I'm not aware of literature that may be out 16 there. 17 Q. Another risk I want to ask you about is 18 whether the TVT Obturator is capable of causing 19 chronic, permanent, debilitating pain? 20 A. I'm sure any surgical procedure can be 21 associated with chronic debilitating pain, and often 22 that might be related to a surgeon's technique. 23 Q. Lifelong risk of erosions, are you aware of 24 that as a risk? Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 20 of 28 PageID #: 450 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 82 1 A. Yes, I am. 2 Q. Are you aware that the erosions can be -- 3 there is a risk that the erosions can be severe, 4 untreatable and incurable? 5 A. I guess I hate to think of the term incurable 6 for a procedure such as this. 7 Q. Would you agree that the risk of the TVT 8 include erosions that can be severe and untreatable? 9 A. Yes. 10 Q. Another risk, that tension on the mesh could 11 collapse the pores of the mesh? 12 A. Yes. 13 Q. Another risk, that complications from the 14 TVTO could cause lifelong need for surgeries to treat 15 erosions and degradation? 16 A. Yes, likely related to surgical technique. 17 Q. Okay. Serious and chronic inflammation that 18 might occur that is not transient? 19 A. I don't know that that would be directly 20 related to the mesh. 21 Q. You don't think that polypropylene mesh as 22 used in a transurethral sling is capable of causing 23 serious and chronic inflammation? 24 MR. MORIARTY: Objection. Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 21 of 28 PageID #: 451 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 83 1 A. I don't -- I don't know that it's the mesh 2 doing that. It could be the tension applied to the 3 tissue and that resulting in chronic inflammation. 4 Q. Do you agree that the mesh can lead to a 5 foreign body reaction in the patient? 6 A. I believe it could. I haven't personally 7 seen that. 8 Q. Do you recognize a risk of TVT Obturator to 9 be capable of causing permanent dyspareunia? 10 A. I guess, once again, I think it's possible 11 but likely related to surgeon technique. 12 Q. How about the risk that the eroded mesh may 13 pose injury to Mrs. Marshall's partner? 14 A. I guess I find that laughable. 15 Q. You don't think that it's possible that her 16 husband could be injured by eroded mesh in his wife? 17 A. I find that hard to believe. 18 Q. You've not seen any reports of that? 19 A. I have not. 20 Q. Do you acknowledge a risk of mesh pores that 21 could collapse under strain and cause unwanted 22 fibrotic bridging? 23 MR. MORIARTY: Objection. 24 A. Repeat the first part. Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 22 of 28 PageID #: 452 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 85 1 Obturator as a high-risk product in internal company 2 documents? 3 MR. MORIARTY: Objection. 4 A. I'm not aware of that. 5 Q. Are you aware that Ethicon possessed evidence 6 that the risk of vaginal scarring was more 7 disclosed -- was more than was disclosed on the IFU? 8 MR. MORIARTY: Objection. 9 A. I'm not aware of that, but I haven't seen 10 that personally. 11 Q. Are you aware that Ethicon had no procedure 12 or professional education program to teach doctors how 13 to properly remove TVTOs after complications arise? 14 A. I wouldn't expect that to be their role. 15 Q. With regard to Ethicon, the manufacturer of 16 this transurethral sling, and any knowledge they had 17 of risks to patients from undergoing placement of the 18 sling, would you want to be informed of those risks as 19 a surgeon? 20 A. Repeat the question. 21 Q. Would you as a surgeon want Ethicon as a 22 manufacturer to share -- impart with you and share 23 with you their knowledge of risks inherent in the 24 product? Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 23 of 28 PageID #: 453 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 86 1 A. I guess I don't expect a company to provide 2 that information to me. I don't know that I could 3 trust it coming from a company. I would look towards 4 the AUA for that kind of information. 5 Q. So you don't rely on Ethicon to -- and 6 Ethicon's representations to you as a surgeon to 7 adequately treat and inform your patients? 8 A. No, I don't rely upon them. 9 Q. You do not? 10 A. I do not. 11 Q. Do you agree that all surgeries have a risk 12 of pain and discomfort? 13 A. All surgeries? 14 Q. Any surgery. 15 A. (Nodding head.) 16 Q. Do you agree that there is a difference 17 between temporary and transient pain and permanent and 18 chronic pain? 19 A. That's a spectrum, yes. 20 Q. Do you agree that this distinction can make a 21 difference in a patient's decision-making about 22 whether to undergo a procedure? 23 A. I don't think that they make that decision 24 based on the information that's in the pamphlet. Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 24 of 28 PageID #: 454 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 92 1 Q. Or xenografts? 2 A. I did three xenografts. 3 Q. Then let's talk about autologous slings. 4 That's when you harvest a piece of a patient's body 5 and use that as a sling, correct? 6 A. That's correct. 7 Q. And you had done many of those before you 8 ever turned to synthetic mid urethral slings; is that 9 right? 10 A. That's correct, and we also used cadaveric, 11 many, many of those. 12 Q. Okay. And the general principles for using 13 cadaveric slings or autologous slings, are they 14 basically the same surgical principles as the TVT and 15 the TVTO? 16 A. Using that term loosely, yes. 17 Q. You're dissecting in through the patient's 18 vagina to access near the urethra to place a sling of 19 some port -- some sort to help control urine flow? 20 A. That's correct. 21 Q. And then after you had done TVTs, that's when 22 you transitioned into TVTO? 23 A. That's correct. 24 Q. You were asked some questions about Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 25 of 28 PageID #: 455 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 95 1 is Exhibit 6 in the stack in front of you, and you 2 were asked questions about her being at 195 pounds and 3 whether that's at an increased risk for SUI and 4 failure of the SUI procedure. Do you recall that line 5 of questioning? 6 A. Yes. 7 Q. Is there anything about a 195-pound patient 8 that would suggest that the SUI procedure was 9 contraindicated? 10 MR. MORIARTY: Objection; beyond the scope. 11 A. Not contraindicated but at increased risk for 12 all types of surgical complications. 13 Q. You've never seen any literature or 14 information from Ethicon saying that their products 15 were not intended for people that are of this stature? 16 A. No, I've not. 17 Q. You were shown a chart. Exhibit 7 is a chart 18 of the risks of mesh versus nonmesh surgery. That 19 one. And I just want to confirm with you as you look 20 at that chart, there is nothing in this chart about 21 the rate of complications for these problems for the 22 different procedures, correct? 23 MR. MORIARTY: Objection. 24 A. Well, I mean, I guess -- I don't perform mesh Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 26 of 28 PageID #: 456 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 96 1 procedures, I never have, so this doesn't 2 particularly apply to me. 3 Q. Okay. 4 A. But regarding your question, I don't see any 5 statistical data. 6 Q. Okay. You were asked about Ms. -- 7 Mrs. Marshall having a hysterectomy and a previous 8 Burch procedure and whether those could cause pain and 9 dyspareunia in a patient. Do you recall that line of 10 questioning? 11 A. That's correct. 12 Q. You don't intend to be testifying here today 13 to a reasonable degree of medical probability that 14 Mrs. Marshall's hysterectomy and Burch procedure 15 caused the pain and dyspareunia she's complaining of 16 in 2011, do you? 17 MR. MORIARTY: Objection. 18 A. I have no way of knowing what the source of 19 her pain is and whether it's related to the 20 suburethral sling or other anatomic problems. 21 Q. But you're not testifying to a reasonable 22 degree of medical probability that that pain and 23 dyspareunia is caused by her hysterectomy and Burch 24 procedure, are you? Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 27 of 28 PageID #: 457 Bruce Lindsay Fariss, Jr. M.D. Golkow Technologies, Inc. Page 97 1 MR. MORIARTY: Objection to form. 2 A. I am not. 3 Q. Final question: You had mentioned that you 4 had gotten brochures from Ethicon but you did not 5 distribute them to your patients and you did not have 6 brochures in your office, and I wondered why that was? 7 MR. MORIARTY: Objection; outside the scope. 8 Go ahead. 9 A. On some occasions I have felt that the 10 information from some brochures might be 11 self-serving, and so I, as a routine, do not hand out 12 brochures. 13 MR. KRUKA: That's all the questions I have. 14 Thank you. 15 MR. MORIARTY: Nothing further. 16 MR. KRUKA: We are finished. 17 THE VIDEOGRAPHER: Please stand by. The time 18 is approximately 3:17 p.m. and this does conclude 19 the deposition of Bruce Fariss, Jr., consisting 20 of two master DVDs. They shall remain in the 21 custody of Golkow Tech, and thank you very much. 22 Appreciate everyone's time today. 23 (Whereupon, the deposition concluded at 24 3:17 p.m.) Case 2:12-cv-02077 Document 65-5 Filed 07/08/16 Page 28 of 28 PageID #: 458 Exhibit F Case 2:12-cv-02077 Document 65-6 Filed 07/08/16 Page 1 of 3 PageID #: 459 jai R irgery A cute and/or C hronic P ain w ith Intercourse A cute and/or C hronic P ain V aginal S carring Infection U rinary P roblem s urinary frequency, urgency, dysuria, retention, or obstruction; incontinence O rgan / N erve D am age B leeding W ound C om plications Inflam m ation F istula F orm ation N eurom uscular P roblem s in pelvic floor m uscles, low er extrem ities, and/or abdom inal area) O ne or m ore surgeries to treat an adverse event o. currence or F ailure F oreign B ody R esponse (sutures/grafts E rosion/E xT osure/E xtrusion (sutures/grafts C cotraction/S hrinkaF e of tissues Case 2:12-cv-02077 Document 65-6 Filed 07/08/16 Page 2 of 3 PageID #: 460 P otential R isks of N on -M esh avid M esh S U I S i. N O N -M E S H A cute and /or C hronic P ain w ith Intercourse A cute and /or C hronic P ain w ith Intercourse A cute and /or C hronic P ain A cute and /or C hronic P ain V aginal S carring V aginal S carring Infection Infection U rinary P roblem s (urinary frequency, urgency, dysuria, retention, or obstruction; incontinence) U rinary P roblem s (urinary frequency, urgency, dysuria, retention, or obstruction; incontinence) O rgan / N erve D am age O rgan / N erve D am age B leeding B leeding W ound C om plications W ound C om plications Inflam m ation Inflam m ation F istula F orm ation F istula F orm ation N eurom uscular P roblem s (in pelvic floor m uscles, low er extrem ities, and /or abdom inal area) N eurom uscular P roblem s (in pelvic floor m uscles, low er extrem ities, and /or abdom inal area) O ne or m ore surgeries to treat an adverse event O ne or m ore surgeries to treat an adverse event R ecurrence or F ailure R ecurrence or F ailure F oreign B ody R esponse (sutures /grafts) F oreign B ody R esponse (m esh) E rosion /E xposure /E xtrusion (sutures /grafts) C ontraction /S hrinkage of tissues E rosion /E xposure /E xtrusion (m esh) C ontraction /S hrinkage of tissues Case 2:12-cv-02077 Document 65-6 Filed 07/08/16 Page 3 of 3 PageID #: 461 Exhibit G Case 2:12-cv-02077 Document 65-7 Filed 07/08/16 Page 1 of 3 PageID #: 462 AMERICAN UROLOGICAL ASSOCIATION PRACTICAL PCNL: From Access to Exit - w A Hands -On Course - - -- LAKE SUCCESS, NY [-REGISTER NOW! JULY 30 -31 2016 American Urological Association ADVERTISEMENT o AUAU My AUA Join Advancing Urology' ABOUT US EDUCATION RESEARCH ADVOCACY INTERNATIONAL PRACTICE RESOURCES AUA Position Statements EDUCATION > Guidelines S Policies> AUA Position Statements > Vaginal Mesh for Suroical Treatment of A U A All your educational needs, all in one place! Now, enhanced access and resources just for AUA members. LeMike AUA POSITION STATEMENT ON THE USE OF VAGINAL MESH FOR THE SURGICAL TREATMENT OF STRESS URINARY INCONTINENCE (SUI) Stress urinary incontinence (SUI) is defined as the involuntary leakage of urine with effort or exertion, such as physical exercise, sneezing or coughing. Approximately 50% of all women experience SUI symptoms, and many of these women are sufficiently bothered by their symptoms to seek treatment from a physician. Pelvic floor muscle exercises and other nonsurgical treatments can be effective therapies, but many women choose to undergo surgery to treat their SUI symptoms. Suburethral synthetic polypropylene mesh sling placement is the most common surgery currently performed for SUI. Extensive data exist to support the use of synthetic polypropylene mesh suburethral slings for the treatment of female SUI, with minimal morbidity compared with alternative surgeries. Advantages include shorter operative time /anesthetic need, reduced surgical pain, reduced hospitalization, and reduced voiding dysfunction. Mesh -related complications can occur following polypropylene sling placement, but the rate of these complications is acceptably low. Furthermore, it is important to recognize that many sling -related complications are not unique to mesh surgeries and are known to occur with non -mesh sling procedures as well. It is the AUA's opinion that any restriction of the use of synthetic polypropylene mesh suburethral slings would be a disservice to women who choose surgical correction of SUI. Additionally, both the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) and the AUA support the use of multi- incision monofilament midurethral slings for the treatment of SUI in properly selected patients who are appropriately counseled regarding this this surgical procedure by surgeons who are trained in the placement of such devices, as well as the recognition and management of potential complications associated with their use. Multiple case series and randomized controlled trials attest to the efficacy of synthetic polypropylene mesh slings at 5 -10 years. This efficacy is equivalent or superior to other surgical techniques. There is no significant increase in adverse events observed over this period of follow - up. Based on these data, the AUA Guideline for the Surgical Management of Stress Urinary Incontinence (2009) concluded that synthetic slings are an appropriate treatment choice for women with stress incontinence, with similar efficacy but less morbidity than conventional non - mesh sling techniques. The AUA Guideline also indicates that intra- operative cystoscopy should be performed during all synthetic sling procedures to identify urinary tract injury. The AUA strongly agrees with the FDA1 that a thorough informed consent should be conducted prior to synthetic sling surgery. The AUA also agrees that surgeons who wish to perform synthetic sling surgery should: Undergo rigorous training in the principles of pelvic anatomy and pelvic surgery. Be properly trained in specific sling techniques. Be able to recognize and manage complications associated with synthetic mesh sling placement. Read more patient- centered information on this issue from the Urology Care Foundation. Additional Resources: Stress Urinary Incontinence Considerations about Surgical Mesh for SUI Information for Patients with SUI Journal of Urology Guidelines Annual Meeting 2016 Are you a Patient? 094 Et .'ti. t+. JUNE ñ -. r-5 11 -14 2016 FUNDAMENTALS IN UROLOGY CHARLOTTESVILLE, VA ADVERTISEMENT AMERICAN UROLOGICAL ASSOCIATION PRACTICAL PCNL: From Access to Exit - A Hands On Course [-REGISTER] LAKE SUCCESS, NY NOW! ADVERTISEMENT Case 2:12-cv-02077 Document 65-7 Filed 07/08/16 Page 2 of 3 PageID #: 463 htto://www.fda4ov/Medicalpevices/Safety/AlertsandNotices/ucm262435.htm Board of Directors, November 2011 Board of Directors, October2013 (Revised) DONATE CONTACT PRESS /MEDIA SECTIONS UROLOGY CARE FOUNDATION DIDUSCH MUSEUM TERM OF USE PRIVACY POLICY Case 2:12-cv-02077 Document 65-7 Filed 07/08/16 Page 3 of 3 PageID #: 464