Blackston et al v. Ethicon, Inc. et al

MOTION

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

1 4823-7579-8836, v. 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 __________________________________ THIS DOCUMENT RELATES TO: Ossie Blackston, et al. v. Ethicon, Inc., et al. Case No. 2:12-cv-01493 Master File No. 2:12-MD-02327 MDL No. 2327 JOSEPH R. GOODWIN U.S. DISTRICT JUDGE PLAINTIFFS OSSIE BLACKSTON AND JOHN BLACKSTON’S MOTION FOR PARTIAL SUMMARY JUDGMENT Pursuant to Fed. R. Civ. P. 56, Plaintiffs Ossie and John Blackston hereby move for partial summary judgment on Defendants Ethicon, Inc. and Johnson and Johnson’s affirmative defenses to the extent they are based on the fault of Ms. Blackston’s physicians because Defendant has failed to provide expert testimony to establish the standard of care applicable to her physicians, or their deviation from such standard of care, as required to establish negligence involving medical malpractice. Plaintiffs’ Memorandum in Support of this Motion is filed separately. WHEREFORE, Plaintiffs respectfully request that the Court issue its order granting summary judgment in their favor as to Defendants’ affirmative defenses to the extent they are based on the fault of Plaintiff Ossie Blackston’s physicians. Case 2:12-cv-01493 Document 54 Filed 07/08/16 Page 1 of 2 PageID #: 350 2 4823-7579-8836, v. 1 Dated this 8th day of July, 2016. Respectfully submitted, By: /s/ Jeffrey M. Kuntz Thomas P. Cartmell MO # 45366 Jeffrey M. Kuntz MO # 52371 Wagstaff & Cartmell LLP 4740 Grand Avenue, Suite 300 Kansas City, MO 64112 Telephone: (816) 701-1100 Facsimile: (816) 531-2372 tcartmell@wcllp.com jkuntz@wcllp.com Counsel for Plaintiffs CERTIFICATE OF SERVICE I hereby certify that on July 8th, 2016, I electronically filed the foregoing document with the Clerk of 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/ Jeffrey M. Kuntz Jeffrey M. Kuntz Case 2:12-cv-01493 Document 54 Filed 07/08/16 Page 2 of 2 PageID #: 351 Exhibit A Case 2:12-cv-01493 Document 54-1 Filed 07/08/16 Page 1 of 6 PageID #: 352 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 MDL No. 2327 ______________________________________________________________________________ AMENDED SHORT FORM COMPLAINT Come now the Plaintiff(s) named below, and for Complaint against the Defendants named below, incorporate The First Amended Master Complaint in MDL No. 2327 by reference. Plaintiff(s) further show the court as follows: 1. Female Plaintiff ___________________________ 2. Plaintiff’s Spouse (if applicable) ___________________________ 3. Other Plaintiff and capacity (i.e., administrator, executor, guardian, conservator) ___________________________ 4. State of Residence ___________________________ 5. District Court and Division in which venue would be proper absent direct filing. ___________________________________________________________ ___________________________________________________________ 6. Defendants (Check Defendants against whom Complaint is made): A. Ethicon, Inc. B. Ethicon, LLC Case 2:12-cv-01493 Document 17 Filed 10/04/12 Page 1 of 5 PageID #: 105Case 2:12-cv-01493 Document 54-1 Filed 7/08/16 Page 2 of 6 PageID #: 3 3 2 C. Johnson & Johnson D. American Medical Systems, Inc. (“AMS”) E. American Medical Systems Holdings, Inc. (“AMS Holdings”) F. Endo Pharmaceuticals, Inc. G. Endo Health Solutions Inc. (f/k/a Endo Pharmaceuticals Holdings, Inc.) H. Boston Scientific Corporation I. C. R. Bard, Inc. (“Bard”) J. Sofradim Production SAS (“Sofradim”) K. Tissue Science Laboratories Limited (“TSL”) 7. Basis of Jurisdiction Diversity of Citizenship Other: ______________________________ A. Paragraphs in Master Complaint upon which venue and jurisdiction lie: ___________________________ ___________________________ ___________________________ B. Other allegations of jurisdiction and venue: ________________________________________________________________________ ________________________________________________________________________ Case 2:12-cv-01493 Document 17 Filed 10/04/12 Page 2 of 5 PageID #: 106Case 2:12-cv-01493 Document 54-1 Filed 7/08/16 Page 3 of 6 PageID #: 354 3 ________________________________________________________________________ ________________________________________________________________________ 8. Defendants’ products implanted in Plaintiff (Check products implanted in Plaintiff) Prolift Prolift +M Gynemesh/Gynemesh PS Prosima TVT TVT-Oturator (TVT-O) TVT-SECUR (TVT-S) TVT-Exact TVT-Abbrevo Other _________________________________________ _________________________________________ 9. Defendants’ Products about which Plaintiff is making a claim. (Check applicable products): Prolift Prolift +M Gynemesh/Gynemesh PS Prosima TVT TVT-Oturator (TVT-O) TVT-SECUR (TVT-S) TVT-Exact Case 2:12-cv-01493 Document 17 Filed 10/04/12 Page 3 of 5 PageID #: 107Case 2:12-cv-01493 Document 54-1 Filed 7/08/16 Page 4 of 6 PageID #: 355 4 TVT-Abbrevo Other _________________________________________ _________________________________________ 10. Date of Implantation as to Each Product: ________________________________ ________________________________ ________________________________ 11. Hospital(s) where Plaintiff was implanted (including City and State): __________________________________ __________________________________ 12. Implanting Surgeon(s): ___________________________________ ___________________________________ 13. Counts in the Master Complaint brought by Plaintiff(s): Count I – Negligence Count II – Strict Liability – Manufacturing Defect Count III – Strict Liability – Failure to Warn Count IV – Strict Liability – Defective Product Count V – Strict Liability – Design Defect Count VI – Common Law Fraud Count VII – Fraudulent Concealment Case 2:12-cv-01493 Document 17 Filed 10/04/12 Page 4 of 5 PageID #: 108Case 2:12-cv-01493 Document 54-1 Filed 7/08/16 Page 5 of 6 PageID #: 356 5 Count VIII – Constructive Fraud Count IX – Negligent Misrepresentation Count X – Negligent Infliction of Emotional Distress Count XI – Breach of Express Warranty Count XII – Breach of Implied Warranty Count XIII – Violation of Consumer Protection Laws Count XIV – Gross Negligence Count XV – Unjust Enrichment Count XVI – Loss of Consortium Count XVII – Punitive Damages Count XVIII – Discovery Rule and Tolling Other Count(s) (Please state factual and legal basis for other claims below): ________________________________________________________________________ ________________________________________________________________________ ________________________________________________________________________ Address and bar information: Attorneys for Plaintiff Case 2:12-cv-01493 Document 17 Filed 10/04/12 Page 5 of 5 PageID #: 109Case 2:12-cv-01493 Document 54-1 Filed 7/08/16 Page 6 of 6 PageID #: 357 Exhibit B Case 2:12-cv-01493 Document 54-2 Filed 07/08/16 Page 1 of 5 PageID #: 358 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 THIS DOCUMENT RELATES TO Civil Action No.: 2:12-cv-01493___________ MDL No. 2327 Ossie Blackston___ 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 therapy department, rehabilitation specialist, chiropractor, or other persons or entities involved in the diagnosis, care and/or treatment of you. Case 2:12-cv-01493 Document 54-2 Filed 07/08/16 Page 2 of 5 PageID #: 359 2 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: Ossie Rebecca Williams Blackston 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: c. The name and address of your primary attorney: Thomas P. Wagstaff, Wagstaff & Cartmell LLP 4740 Grand Ave. Suite 300 Kansas City, MO 64112 2) Your Social Security Number: 213-70-1493 3) Your date of birth: 10/11/1959 4) Your current residence address: 8202 Sagramore Road, Rosedale, MD 21237 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 Case 2:12-cv-01493 Document 54-2 Filed 07/08/16 Page 3 of 5 PageID #: 360 5 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 Lot# 3256680 05/07/2009 MedStar Franklin Square Medical Center 9000 Franklin Square Dr, Baltimore, MD 21237 Urinary stress incontinence Conrad Duncan, M.D. 3407 Wilkens Ave Ste 210 Baltimore, MD 21229 Product No. 2: Product No. 3: 2) For each pelvic mesh product identified above, describe your understanding of the medical condition for which you received the pelvic mesh product(s): Stress urinary incontinence 3) For each Ethicon, Inc. pelvic mesh product identified above, indicate if, prior to implantation, you received any written and/or verbal information or instructions, including any risks or complications that might be associated with the use of the product(s)? Yes _X_ No ___ Don’t Know ___ If Yes: a. Provide the date you received the written and/or verbal information or instructions: b. Identify by name and address the person(s) who provided the information or instructions: Conrad Duncan, M.D. 3407 Wilkens Ave, Ste 210, Baltimore, MD 21229 c. What information or instructions did you receive? Dr. Duncan explained the risk of infection, bleeding, and anesthesia. Further, Dr. Duncan explained the myomectomy procedure in detail and that the implanting of the mesh sling would help the stress incontinence. plaintiff does not recall the exact date but believes Plaintiff does not recall the exact date, but believes it was in late April. Further answering, Plaintiff does not remember any additional details and Case 2:12-cv-01493 Document 54-2 Filed 07/08/16 Page 4 of 5 PageID #: 361 Case 2:12-cv-01493 Document 54-2 Filed 07/08/16 Page 5 of 5 PageID #: 362 Exhibit C Case 2:12-cv-01493 Document 54-3 Filed 07/08/16 Page 1 of 20 PageID #: 363 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: Ossie Blackston, et al. v. Ethicon, Inc., et al. Case No. 2:12-cv-01493 Master File No. 2:12-MD-02327 MDL No. 2327 JOSEPH R. GOODWIN U.S. DISTRICT JUDGE CASE SPECIFIC REPORT OF JOSEPH CARBONE, M.D.: OSSIE BLACKSTON Prepared by Joseph Carbone, M.D. June 3, 2016 Case 2:12-cv-01493 Document 54-3 Filed 07/08/16 Page 2 of 20 PageID #: 364 1 EXPERT REPORT OF JOSEPH M. CARBONE, M.D. Matter of Ossie Blackston, et. al. v. Ethicon, Inc. et. al. I have prepared this Expert Report in the matter of Ossie Blackston, et. al. v. Ethicon, Inc., et al., Case No. 2:12-cv-01493, filed in In re: Ethicon, Inc. Pelvic Repair System Products Liability Litigation, MDL No. 2327, currently pending in the United States District Court for the Southern District of West Virginia, before the Hon. Joseph R. Goodwin. My opinions set forth in this report are made to a reasonable degree of medical certainty, and are based on information and knowledge I have acquired from my research and review of medical literature, personal experience in private practice, education, training, teaching, and discussion and interaction with other pelvic surgeons in professional activities and conferences. My opinions are also based on my review of the medical records and general and case specific expert reports exchanged in the Blackston case. My curriculum vitae is attached as Exhibit A. Plaintiff Ossie Blackston Ossie Blackston was born on October 11, 1959. She currently resides in Rosedale, Maryland, with her husband, John Blackston, whom she married in 1997. She was previously married to Joseph Bradley from 1975-1979, Reginald Thompson, from 1980-1985, and Tony Davenport, from 1991-1995. Ms. Blackston has four children from four pregnancies, all of which were NSVD births – Lisa Morton (age 42), Tenira Jones (age 38), Marvin Thompson (age 34), and Tony Davenport (age 28). Most recently, Ms. Blackston was employed as a records clerk at the Woodstock Job Corps Center in Woodstock, Maryland. She has held similar positions elsewhere in the last twenty-five years. Case 2:12-cv-01493 Document 54-3 Filed 07/08/16 Page 3 of 20 PageID #: 365 2 Ms. Blackston’s Medical History Prior to the May 7, 2009 Surgery Ms. Blackston experienced rectal issues, including bleeding and hemorrhoids as early as 1992. (MRSH_MDR000002-6). She was diagnosed with a vaginal yeast infection on November 12, 1993. (FRSH_MDR00007-13). On May 14, 1998, Ms. Blackston presented with a right Bartholin’s gland cyst measuring approximately 3 cm, which was punctured and drained. (GBMC_MDR00241-263). Her medical history at this point included a heart murmur, back problems, and anemia. On March 26, 2002, Ms. Blackston complained of vaginal itching and discharge lasting for six days, which was diagnosed as vaginitis. She had a history of yeast infections. A nabothian cyst was also noted on her uterus. A month later, on April 25, 2002, Ms. Blackston complained of abdominal and back pain and whitish discharge with her menses. She was assessed as having vaginal candidiasis and dysmenorrhea. (FSFHC_MDR00225-226, 275, 277- 279). A pelvic ultrasound was performed on May 1, 2002, for low abdominal pain, which revealed a 2 cm left uterine fibroid. (FSFHC_MDR00245). Ms. Blackston later tested positive for hematochezia on March 15, 2004. (FSFHC_MDR00218-219). On April 7, 2004, Ms. Blackston reported occasional incontinence from sneezing. Subsequent findings indicated uterine fibroids and occasional stress incontinence, and kegel exercises were discussed. (FSFHC_MDR00215-216). On September 15, 2005, she complained of white, chunky vaginal discharge with mild burning irritation and odor, possibly from intercourse. Ms. Blackston was prescribed with antibiotics for vaginitis. (FSFHC_MDR00203). She began taking Celexa on September 20, 2005. (FSFHC_MDR00201-202). Bacterial Case 2:12-cv-01493 Document 54-3 Filed 07/08/16 Page 4 of 20 PageID #: 366 3 vaginosis was noted again on July 24, 2006, which caused stinging and worsened after intercourse. (MSFHC_MDR00192). Ms. Blackston complained again on September 6, 2007 of a vaginal abscess to her right vaginal area, both internally and externally, for the last 5 days, with no drainage. She was diagnosed with another Bartholin’s Abscess, whereupon another incision and drainage was performed. (FRSH_MDR00072-77). She was prescribed bactrim and Percocet for post- operative care. Ms. Blackston presented to the emergency room on October 7, 2007 for a recurrent Bartholin’s abscess with swelling and no drainage, which was again incised and drained. (FRSH_MDR00102-110). On May 27, 2008, she reported additional trouble with lower abdominal discomfort between menses with heavier bleeding than normal and some spotting. (FSFH_MDR00137-139). Complaining of discharge, lower abdominal cramping, fear of STDs, and occasional stress incontinence, Ms. Blackston was diagnosed with Cervicitis on June 27, 2008. (FRSH_MDR00111-121). She was treated with Azithromycin and Ceftriaxone. On August 27, 2008, Dr. Marwan Hajj assessed Ms. Blackston for pelvic pain and fibroids. (MAHJ_MDR00009-10). Testing with Dr. Hajj on September 10, 2008 revealed a left sided intramural fibroid measuring 3.6 x 3.1 x 2.8 cm and an inhomogeneous uterus, with possible multiple smaller fibroids. (MAHAJ_MDR00012-18). Ms. Blackston next presented to Dr. Jahangir Khan on November 19, 2008 for an endoscopy and fiber optic escophagogastroduodenoscopy revealing alteration in bowel habit, dyspepsia, abdominal pain, with mild reflux esophagitis and gastritis. Testing also revealed a spastic colon, diverticulosis, and a sigmoid colon polyp. An excisional polypectomy was performed. That same week, she complained of vaginal bleeding after intercourse, which lasted Case 2:12-cv-01493 Document 54-3 Filed 07/08/16 Page 5 of 20 PageID #: 367 4 for about 15 minutes, which she described as different from menstrual bleeding. She also reported right groin pain that was worsened by intercourse and was exacerbated by walking, relieved with rest, and did not radiate. Ms. Blackston was recommended to follow-up with her gynecologist for fibroids. (FSFHC_MDR00114-116). Her complaints of lower abdomen discomfort continued on January 2, 2009, describing heavy periods and fibroids. Testing revealed peptic ulcer disease, H. Pylori, GERD, hypertension, and perimenopausal menorrhagia, for which surgical options were discussed. (FSFHC_MDR00096-98). Ms. Blackston was first seen on February 18, 2009 by Dr. Conrad Duncan in referral from Dr. Myra Patel for “lower right abdomen discomfort on and off for past years.” She told Dr. Patel that “she didn’t want the hysterectomy mentioned by (the) provider she was seeing” so Dr. Patel decided she would “refer to (a) new provider closer to where she lives” to discuss uterine-sparing treatment for her uterine fibroids. At that first visit of February 18, 2009, Dr. Duncan diagnosed Ms. Blackston with dysmenorrhea and menometrorrhagia secondary to uterine fibroids, overactive bladder, and stress urinary incontinence. The plan included anticholinergic therapy consisting of Vesicare 5 mg daily for the overactive bladder and laparoscopic myomectomy for the uterine fibroids. Since she had elected to proceed with surgical intervention for her uterine fibroids, the decision was made to perform a midurethral sling at the time of her laparoscopic myomectomy for the stress urinary incontinence. (FSFHC_MDR00153-154). At this point, surgical and non-surgical options were discussed, including a laparoscopic myomectomy, possible open procedure, and a midurethral sling to treat her stress incontinence. (Dr. Conrad Duncan, May 2, 2016 Dep. Tr. 55:19-60:12). On March 11, 2009, Ms. Blackston reported lower abdominal cramping, and bleeding after intercourse during the past two weeks. (FSFHC_MDR00102-105). Shortly after, on March Case 2:12-cv-01493 Document 54-3 Filed 07/08/16 Page 6 of 20 PageID #: 368 5 23, 2009, Ms. Blackston reported concern over black vaginal discharge and odor for the previous two weeks and blood in her stools, which was suspected to be internal hemorrhoids. (FSFHC_MDR00090-92). She complained again of pelvic pressure on April 7, 2009. The May 7, 2009 Surgery Ms. Blackston’s pre-operative visit on April 27, 2009 indicated current symptoms of positive PPD, perimenopausal menorrhagia, peptic ulcer disease, H. Pylori, blood in stool, hypertension, recurrent palpitations, cardiac murmur, ankle/foot joint pain, dizziness, anemia, and a history of right ganglion cyst removal. Her current medications were Celexa 20 mg, Atenolol 50 mg, Hydrochlorothiazide 25 mg, Zantac 150 mg, Isoniazid 300 mg, and Pyridoxine HCL 50 mg. She was 5’ 4” tall and weighed 195.6 pounds. (FRSH_MDR00142-155). On the day of the surgery, Dr. Duncan administered informed consent. Benefits discussed included improvement of symptoms, including SUI. Alternatives that were discussed included doing nothing, medical treatment, uterine artery embolization – for fibroids, a Burch procedure, and urethral bulking – that would have not applied to Ms. Blackston’s type of stress incontinence. (Dr. Conrad Duncan, May 2, 2016 Dep. Tr. 55:19-60:12). Risks included infection; damage to the bowel, bladder, ureter, major blood vessels, and failure of the procedure and risk of erosion. (Dr. Conrad Duncan, May 2, 2016 Dep. Tr. 55:19-60:12). A brochure provided by Dr. Duncan also included difficulty urinating, pain, scarring, pain with intercourse, mesh exposure, extrusion, fistula formation, inflammation, incomplete relief from urinary incontinence, or urinary tract obstruction. 1 Dr. Duncan also included an expanded informed consent that he applied at the time which included dyspareunia. (Dr. Conrad Duncan, May 2, 1 ETH.MESH.08003292-3 Case 2:12-cv-01493 Document 54-3 Filed 07/08/16 Page 7 of 20 PageID #: 369 6 2016 Dep. Tr. 52:24-54:12, 140:10-19, 143:2-23). Ms. Blackston opted for uterine preservation and acknowledged the risks that her symptoms may not be relieved. On May 7, 2009, Ms. Blackston underwent diagnostic laparoscopy with mini-laparotomy and exploratory laparotomy to perform multiple myomectomies and uterine biopsy. In addition, a TVT-O mid urethral sling was placed. Uterine fibroid specimens were sent to pathology. Intra-operative findings included an enlarged boggy uterus with several small discrete/fibroids. The uterus was greatly enlarged due to diffuse adenomyosis. The report also notes that Dr. Duncan found Ms. Blackston to be positive for interstitial cystitis. Ms. Blackston tolerated the procedure well and no damage to the bladder or the urethra was found due to the passage of the TVT-O. (FRSH_MDR00184-186). Pathology indicated leiomyomata fibroids measuring 1.8 cm and 3.2 cm respectively, myometrium adenomyosis, and endometriosis on the left side. (FRSH_MDR00193-194). Ms. Blackston’s first post-operative course Ms. Blackston presented to the emergency room three days later for pain with urination – namely passage of clots, swelling of the abdomen when eating, left-side vaginal pain, and lower back pain. A CT scan of the abdomen showed a small amount of free fluid in the pelvis posterior to the uterus. No evidence of an abscess was found. She was prescribed Dilaudid and Torodol for her pain. (FRSH_MDR00200-218). The following day, on May 11, 2009, in a telephone conversation with Dr. Duncan, Ms. Blackston reported that her pain level had improved and she was able to pass a bowel movement. (MAIC_MDR00008). That same week, on May 15, she presented for acute pelvic pain, with muscular aches. She also complained of urinary frequency and some bleeding, with no signs of UTI. (FSFHC_MDR00074-76) Case 2:12-cv-01493 Document 54-3 Filed 07/08/16 Page 8 of 20 PageID #: 370 7 She complained of pelvic pressure again to Dr. Hajj on June 4, 2009, who noted additional fibroids and that her uterus was “very inhomogeneous.” (MAHAJ_MDR00008). Ms. Blackston visited Dr. Duncan on June 9, 2009 where he noted she was healing well. (MAIC_MDR00006). In a follow-up visit, Ms. Blackston reported that her post-surgery pain had subsided. (MAIC_MDR00005). Dr. Duncan noted that her diagnostic report was suggestive of interstitial cystitis. Although the diagnostic criteria of Hunter’s ulcers were not met in Ms. Blackston’s case, the petechia shown were similar to those seen with patients suffering from interstitial cystitis, which led Dr. Duncan to this working diagnosis. Photographic cystoscopy records were not available for Dr. Duncan to review this diagnosis. (Dr. Conrad Duncan, May 2, 2016 Dep. Tr. 109:2-115:15). In a subsequent visit with Dr. Duncan, Ms. Blackston’s incisions were healing well, but she complained of additional vaginal discharge. He prescribed a 500 mg dosage of Flagyl for infection. A positive test for adenomyosis was noted once more. (MAIC_MDR00004). Several months later, Ms. Blackston presented with mesh exposure to Dr. Duncan, on November 24, 2009. An examination revealed no pain, no SUI symptoms, and urinary frequency causing her to void 6-8 times a day. She was prescribed Detrol for overactive bladder and management options were presented by Dr. Duncan, including mesh revision if urgency continued. (MIAC_MDR00003). Ms. Blackston stopped taking her Detrol due to cost and requested a time to undergo a revision of her mesh exposure. She reported leaking urine at least 8 times a day. After a pelvic examination on December 30, 2009, Dr. Hajj referred Ms. Blackston to Dr. Joan Blomquist at the Greater Baltimore Medical Center. (MAHAJ_MDR00008). Dr. Blomquist evaluated Ms. Blackston on January 6, 2010, and noted improvement in her SUI and Case 2:12-cv-01493 Document 54-3 Filed 07/08/16 Page 9 of 20 PageID #: 371 8 cough/sneeze incontinence, but discomfort due to the mesh exposure, which measured 1x1 cm, plus increased urinary frequency, urgency, and occasional urge-type incontinence. (MAHAJ_MDR00016; Dr. Joan Blomquist, May 2, 2016 Dep. Tr. 39:18-40:4). A urologically oriented neurologic examination noted Ms. Blackston was within normal limits including normal bulbocavernous and anal reflex. Dr. Blomquist recommended urodynamic and cystoscopy testing to be performed before the revision surgery. (MAHAJ_MDR00016). The January 22, 2010 cystourethroscopy revealed a normal urethra and bladder, and palpable mesh to the right of the urethra, but that no mesh had worked its way into the urethra or bladder. (PSR00014, Dr. Joan Blomquist, May 2, 2016 Dep. Tr. 42:14-43:7). Urodynamics indicated detrusor over activity. (Dr. Joan Blomquist, May 2, 2016 Dep. Tr. 40:14-42:11; GBMC_MDR00193-194). Dr. Blomquist’s assessment confirmed urge urinary incontinence and mesh exposure in Ms. Blackston’s vagina. At this point, Ms. Blackston was counseled on these findings and presented with options, which included continuation of her Detrol regimen, or moving forward with the planned operation for mesh removal. Ms. Blackston opted for surgical revision of the mesh. (GBMC_MDR00193-194). Risks and benefits were reviewed, included bleeding, infection, damage to adjacent organs, and recurrence of SUI. (PSR00014). Ms. Blackston presented at her pre-operative physical exam on January 27, 2010 with pre-operative complaints of bladder discomfort, dyspareunia, frequency, and cramping, as was assessed for adenomyosis of the uterus and urinary frequency. Her medications at the time included Celexa, Atenolol, HCTZ, Pyridoxine, Zantac, Detrol, Estrace vaginal cream, and a Pulmicort inhaler for asthma. (GBMC_MDR00136-138). A subsequent pre-operative history and physical the day before her operation revealed additional medications, including Asmanex, hydrochlorothiazide, atenolol, and paroxetine. Informed consent was delivered, at which point Case 2:12-cv-01493 Document 54-3 Filed 07/08/16 Page 10 of 20 PageID #: 372 9 Ms. Blackston desired to move forward with surgical management of her revision. (GBMC_MDR00159-160). Risks included damage to surrounding tissues, pain, recurrence of erosion, and recurrence of incontinence. (GBMC_MDR00346-347) The February 18, 2010 Surgery On February 18, 2010, Ms. Blackston was taken back to the operating room by Dr. Blomquist for just such a revision surgery. The preoperative diagnosis was listed as “a 50-year- old with a history of a transobturator tape placement in 2009 in an outside hospital presenting with dyspareunia with vaginal mesh erosion.” Exam under anesthesia revealed a mesh exposure, 1 cm to the right of the urethra, with no other evidence of mesh erosion in other areas of the vagina. The mesh was fully dissected off the vaginal mucosa to an area of around 1 x 1 cm and excised without further evidence of any mesh fibers visualized or palpated. Cystoscopy revealed no bladder or urethral injury and the vaginal incision was closed with absorbable sutures. Ms. Blackston was noted to have tolerated the procedure well. (GBMC_MDR141, 161-162). Dr. Blomquist confirmed that the operation was successful and their revision of the mesh was sufficiently thorough having not found mesh erosion elsewhere in the vagina. (Dr. Joan Blomquist, May 2, 2016 Dep. Tr. 55:4-20). Pathology revealed a strip of dark red synthetic mesh measuring 1.5 x 0.5 x 0.1 cm with embedded blue suture material in formalin. (GBMC_MDR00187). Ms. Blackston’s second post-operative course Ms. Blackston reported she was doing well in her two-week follow-up, with no bleeding and optimal bladder function. (UGBMC_MDR00035). A month later, an examination on April 7, 2010, revealed a well-healed, non-tender anterior vagina without spotting, bleeding or discharge, but complained of significant urgency/frequency if she forgot to take her Detrol, and Case 2:12-cv-01493 Document 54-3 Filed 07/08/16 Page 11 of 20 PageID #: 373 10 also described dark urine. (UGBMC_MDR00036). Upon returning to sexual activity, however, Ms. Blackston described during her visit to Dr. Blomquist on June 30, 2010 “increasing problems with pain/cramping across (her) lower pelvis after intercourse.” Dr. Blomquist listed potential causes for Ms. Blackston’s dyspareunia as “adhesions secondary to myomectomy” versus “return of fibroids.” These were now in the differential diagnosis as causes for her continued dyspareunia since erosion of the mesh material was no longer a consideration. (UGBMC_MDR00037). By October 13, 2010, despite treatment with pain medications, Ms. Blackston’s “lower pelvic pressure, discomfort, (and) deep dyspareunia continue(d).” On June 30, 2010, she reported her incontinence issues had improved but noted increasing issues with pain and cramping across her pelvic area during intercourse, which she had since resumed. She was prescribed with Metrogel for bacterial vaginitis and assessed for dyspareunia secondary to her myomectomy. Ms. Blackston agreed to try NSAIDs as a treatment. (UGBMC_MDR00038). On February 2, 2011, almost 1 year after her revision surgery, Ms. Blackston’s dyspareunia persisted. It was documented the her “husband feels that he may be feeling mesh again during intercourse.” Nevertheless, vaginal examination revealed that the anterior wall was “intact, (with) no evidence of erosion.” Notably, however, Dr. Blomquist describes a “small nodule” in the superior vagina that is slightly tender. This finding, however, remained low on the differential diagnosis as a potential cause for Ms. Blackston’s dyspareunia. (UGBMC_MDR00039). On April 1, 2011, Ms. Blackston returned with persistent complaints of vaginal “irritation (and) dyspareunia.” She described that she felt like she was “not lubricated enough.” New additions to the differential diagnosis included “atrophic vaginitis” and “foreplay deficit.” On examination of April 13, 2011, Ms. Blackston’s dyspareunia continued. (UGBMC_MDR00040). Shortly after, on April 11, 2011, she presented to Dr. Samyra C. Sealy Case 2:12-cv-01493 Document 54-3 Filed 07/08/16 Page 12 of 20 PageID #: 374 11 for decreased urination but no longer had any discharge. (FSFHC_MDR00028-31). Two days later, she complained to Dr. Blomquist of pelvic pressure, vaginal discharge, decreased urination, and ongoing irritation for her husband during intercourse. She was assessed for mild atrophy and a small 1-2 mm “pea-like” right fornix mass. (UGBMC_MDR00032-41). The small “1-2 mm, pea-like” area in the right fornix was again described but it was “not tender to palpation” and showed “no change from previous (exam).” Vagifem and a vaginal lubricant were prescribed. When Ms. Blackston and her husband returned on August 3, 2011 complaining of continued sexual discomfort, Dr. Blomquist agreed to remove the nodule, and also recommended the “husband (saw his) primary to make sure he does not have any underlying infection or other personal cause of his irritation.” Ms. Blackston indicated that she tried Vagifem and Estrace cream, but her husband felt that this created too much discharge. No mesh erosion was noted nor was any palpable. The right fornix nodule was tender to the touch, which Ms. Blackston felt was the cause of her husband’s discomfort. (UGBMC_MDR00030-31). The right fornix nodule was excised on September 12, 2011, which measured approximately 0.5 cm at the time of removal. (GBMC_MDR00093-94). Pathology described a vaginal apex calcified nodule, possible calcified phlebolith or calcified leiomyoma. No evidence of malignancy was present. (GBMC_MDR00118). In her one-month follow-up with Dr. Blomquist, Ms. Blackston noted no complaints with intercourse aside from occasional cramping, and no complaints from her husband. Dr. Blomquist determined that her issue with intercourse was resolved following the removal of the nodule, and that Ms. Blackston and her partner’s issues were due to the nodule rather than mesh. There were no reports of dyspareunia after that. (GBMC_MDR00093-94; Dr. Joan Blomquist, May 2, 2016 Dep. Tr. 103:4-104:18). Dr. Case 2:12-cv-01493 Document 54-3 Filed 07/08/16 Page 13 of 20 PageID #: 375 12 Blomquist further concluded that the removed nodule was not related in any way to mesh. (Dr. Joan Blomquist Dep. Tr. 37:1-22). On February 5, 2013, Ms. Blackston presented for left sided, lower abdominal pain, which had persisted for the last three months, including bloating and increased girth with abdominal burning sensations. She also reported urinary urgency, urge incontinence, and nocturia over the last three months. She denied any symptoms of SUI. Dr. Blomquist attributed these issues to an enlarged uterus that she found upon examination, and recommended an ultrasound, kegel exercises, and behavioral modification. (UGBMC_MDR00022-24). A March 2, 2013 ultrasound noted the uterus was anteverted measuring 8.8 x 3.3 x 4.3 cm, with a single 3 mm cervical nabothian cyst. No uterine fibroids were identified. (UGBMC- MDR00001). Commenting on the results of the ultrasound, Dr. Blomquist attributed this pain to a variety of possible sources, including her myomectomy, uterine, and gastrointestinal issues. She ruled out Ms. Blackston’s TVT-O implant as a source of this pain. (Dr. Joan Blomquist, May 2, 2016 Dep. Tr. 68:5-71:5). Ms. Blackston later complained of possible prolapse on January 29, 2014 and increased urge urinary incontinence. Dr. Blomquist attributed her prolapse to bulge symptoms from vaginal atrophy and her increased incontinence to medication noncompliance. (Dr. Joan Blomquist, May 2, 2016 Dep. Tr. 66:15-67:4). Her last visit to Dr. Blomquist was on February 4, 2015, complaining of “pain from mesh.” Dr. Blomquist’s evaluation was that her complaints were not due to vaginal pain but from her gastrointestinal issues. (UGBMC-MDR00055-57; Dr. Joan Blomquist, May 2, 2016 Dep. Tr. 64:8-66:14) Case 2:12-cv-01493 Document 54-3 Filed 07/08/16 Page 14 of 20 PageID #: 376 13 Opinions Based on the discussion above, I hold the following opinions to a reasonable degree of medical certainty. I reserve the right to supplement my opinions at a later time based on, among other things, newly received information, records, testimony, or an independent medical exam of Ms. Blackston. In my practice, I complete a differential diagnosis to determine the cause of a patient’s symptoms. Differential diagnosis is a universally accepted methodology in the United States by practicing physicians, whereby a physician “rules in” potential causes and then by elimination, the physician “rules out” a less likely cause. I have performed this differential diagnosis on Ms. Blackston’s complaints after reviewing her medical history, both testimonial and as supplied in the medical records provided, and reviewing her test results, including laboratory tests and imaging studies. I performed this differential diagnosis to evaluate potential likely causes of her complaints. I also assessed medical comorbidities as potential causes of Ms. Blackston’s symptoms. Review of the medical records reveals that, despite the exposure of the mesh material, the complaints experienced by Ms. Blackston can be explained by other medical comorbidities and were not caused by the mesh exposure itself. My review of the operative report revealed that the mesh implantation procedure was completed within the standard of care. I found no deviation from the standard of care provided by Dr. Duncan. It is also my opinion, to a reasonable degree of medical certainty, that at the time of Ms. Blackston’s surgery, there were no safer and more effective alternative products or procedures available for the treatment of SUI than the TVT-O. In a study comparing Burch culposuspension versus Kelly plication, the success rates for the treatment of SUI were 75% for the Kelly plication and 87.8% for the Burch procedure. Case 2:12-cv-01493 Document 54-3 Filed 07/08/16 Page 15 of 20 PageID #: 377 14 Similarly, a Cochrane review comparing needle suspension surgeries with the Burch culposuspension showed success rates of 74% for the needle suspension versus 86% for the Burch procedure. With the advent of TVT, a two-year follow-up by Ulmsten reported that 92% of the patients were cured or significantly improved. By accomplishing the same tension-free support at the mid-urethra, both the TVT and TVT-O would be expected to have similar results. A review published around the time of Ms. Blackston’s surgery supported this hypothesis. As for the mesh exposure, it represents a well-known and well-documented possible complication of all mesh surgeries. The risk for vaginal mesh exposure in the abdominal- sacroculpopexy (ASC) in the literature is 10% at 7 years. In addition, on October 20, 2008, prior to Ms. Blackston’s surgery, the FDA issued a Public Health Notification to all healthcare practitioners regarding complications associated with the transvaginal placement of surgical mesh to treat Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). It read: “The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood 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.” Specific to the TVT-O product, Ethicon warned of vaginal mesh exposure and dyspareunia in various materials such as the IFU, surgical technique guide, professional education and the TVT Surgeons Resource Monograph. In the IFU, surgeons were warned of “adverse reactions” including “mesh extrusion, exposure, or erosion, fistula formation, or inflammation.” Case 2:12-cv-01493 Document 54-3 Filed 07/08/16 Page 16 of 20 PageID #: 378 15 Following the removal of the vaginal phlebolith, Ms. Blackston was described as “doing well post op.” She “had intercourse several times with no complaints from (her) partner.” This remains the case throughout the remainder of her visits to Dr. Blomquist including her most recent on February 4, 2015. She continues to do well with respect to pelvic pain and dyspareunia and has an excellent prognosis. Thus, while the differential diagnosis for the cause of Ms. Blackston’s dyspareunia includes erosion of the mesh material, adhesions secondary to myomectomy, return of fibroids, atrophic vaginitis, gastrointestinal issues, and foreplay deficit, I agree with Dr. Blomquist’s assessment that the calcified vaginal phlebolith, more likely than not, was the source of Ms. and Mr. Blackston’s sexual discomfort prior to removal. (Dr. Joan Blomquist, May 2, 2016 Dep. Tr. 103:4-104:18). It is my opinion, to a reasonable degree of medical certainty, based on a review of the medical records and completion of a differential diagnosis to determine the cause of Ms. Blackston’s symptoms that, despite the erosion of the mesh material, the dyspareunia experienced by Ms. Blackston can be explained by other medical comorbidities and was not caused by the mesh exposure itself. I also agree with Dr. Blomquist’s assessments that Ms. Blackston’s pain symptoms can be traced to other etiologies, and were not caused by her TVT-O implant. (Dr. Joan Blomquist, May 2, 2016 Dep. Tr. 68:5-71:5). Ms. Blackston had a number of other diagnoses that are known to cause pain, including mentions throughout her records of interstitial cystitis, adenomyosis, and fibroids. If, in fact, she has interstitial cystitis, that is a common cause of pelvic pain. Moreover, in reviewing the record, I agree with Dr. Blomquist’s most recent assessment that Ms. Blackston’s complaints of “mesh pain” were, more likely than not, due to her gastrointestinal issues. Case 2:12-cv-01493 Document 54-3 Filed 07/08/16 Page 17 of 20 PageID #: 379 16 The records do not support the connection between UTIs and the TVT-O. There is no mechanical connection. Ms. Blackston’s records indicate she was prone to infection, particularly her treatment for urinary tract infections and bacterial vaginosis prior to her mesh implant. Postoperatively, Ms. Blackston progressed through menopause, and was noted by Dr. Blomquist to have vaginal atrophy. The gradual lack of estrogen presents a significant risk factor leading to UTIs. There is substantial data to support that connection. Nothing in the literature indicates that TVT or TVT-O products can create interrupted menstrual cycles. Ms. Blackston’s pre-implant history of dysmenorrhea, metrorrhagia, and ongoing symptoms of adenomyosis indicate more plausible alternative explanations for these symptoms. Ultimately, Ms. Blackston progressed through menopause which can create interrupted menstrual cycles. As for her urinary problems, Ms. Blackston’s urinary symptoms predated her original mesh surgery. She had several risk factors for urinary leakage including four pregnancies, four vaginal deliveries and uterine fibroids. Preoperatively, she was noted to have overactive bladder, interstitial cystitis and stress urinary incontinence. She was progressing through menopause which can lead to the genitourinary syndrome of menopause (GSM). In a study by Robinson and Cardozo (2003), about 20% of postmenopausal women had severe urgency and almost 50% had SUI. In comparison, the AUA reported that for synthetic slings placed at the midurethra in which concurrent prolapse treatment was performed the risk for de novo urge incontinence is only 11% and the risk for persistent or recurrent SUI based on the cured/dry analysis is only 15%. It is my opinion, to a reasonable degree of medical certainty, that it is more likely than not that Ms. Blackston’s complaint of urinary and bladder problems was caused by her preexisting comorbid conditions and GSM rather than her mesh surgeries. Case 2:12-cv-01493 Document 54-3 Filed 07/08/16 Page 18 of 20 PageID #: 380 17 There is no evidence in this case of conditions that plaintiffs’ experts often claim in cases like this, such as degradation, chronic inflammation, chronic foreign body reaction, loss of pore size, fibrotic bridging, excessive scarring, contraction, deformation, fraying, roping, curling, cytotoxicity or cancer. Independent Medical Examination At the time of my signing of this report, I had not yet had the opportunity to perform an independent medical examination (IME) of Ms. Blackston, which I would like to do. I reserve the right to supplement my report following my own examination of Ms. Blackston and receipt of all documentation associated with this examination of her. Case 2:12-cv-01493 Document 54-3 Filed 07/08/16 Page 19 of 20 PageID #: 381 18 ATTACHMENT List of Case-Specific Materials Reviewed by Joseph M. Carbone, MD Case 2:12-cv-01493 Document 54-3 Filed 07/08/16 Page 20 of 20 PageID #: 382