Kenneth A. Murphy Phillip J. Combs (admitted pro hac vice ) [email protected] [email protected] Attorney Identification No. 58162 THOMAS COMBS & SPANN PLLC Melissa A. Merk 300 Summers Street, Suite 1380 [email protected] Charleston, WV 25301 Attorney Identification No. 90363 Telephone: 304-414-1800 Molly E. Flynn Facsimile: 304-414-1801 Attorney Identification No. 205593 [email protected] Kim M. Schmid (admitted pro hac vice ) DRINKER BIDDLE & REATH LLP [email protected] One Logan Square, Suite 2000 BOWMAN AND BROOKE LLP Philadelphia, PA 19103-6996 150 South Fifth Street, Suite 3000 Telephone: 215-988-2700 Minneapolis, MN 55402 Facsimile: 215-988-2757 Telephone: 612-672-3247 Facsimile: 612-672-3200 Julie A. Callsen [email protected] Nils Burton Snell Attorney Identification No. 323883 [email protected] Attorney Identification No. 89455 TUCKER ELLIS LLP BUTLER SNOW LLP 950 Main Avenue, Suite 1100 500 Office Center Drive, Suite 400 Cleveland, OH 44113 Fort Washington, PA 19034 Telephone: (216) 592-5000 Telephone: (267) 513-1884 Facsimile: (267) 513-1701 Attorneys for Defendants Ethicon, Inc. and Johnson & Johnson IN RE: PELVIC MESH LITIGATION PHILADELPHIA COUNTY COURT OF COMMON PLEAS TRIAL DIVISION Ella Ebaugh, et al., Plaintiffs, JULY TERM 2013 v. No. 0866 Ethicon, Inc., et al., Defendants. DEFENDANTS ETHICON, INC. AND JOHNSON & JOHNSON’S PRE-TRIAL MEMORANDUM Opposing Counsel: Lee Balefsky Kila Baldwin Kline & Specter, P.C. Michael Cavaliere 1525 Locust St., 19th Flr. Christopher Gomez Philadelphia, PA 19102 Tracie Palmer Attorneys for Plaintiffs Elia Robertson Filing Date: July 7, 2017 Control No: Defendants Ethicon, Inc. and Johnson & Johnson (“Ethicon”) , by and through undersigned counsel, and pursuant to the Second Amended Case Management Order and subsequent agreements reached by the parties, respectfully submit this Pre-Trial Memorandum. I. STATEMENT OF THE CASE A. Introduction Plaintiffs Ella and Marvin Ebaugh assert claims arising out of Ms. Ebaugh’s TVT and TVT Secur implants, which are prescription pelvic mesh medical devices manufactured and sold by Ethicon. She was implanted with a TVT Secur on May 31, 2007 to treat her stress urinary incontinence (“SUI”), and implanted with a TVT on July 12, 2007 to treat continuing complaints of SUI after being advised by her implanting surgeon that the TVT Secur failed. She claims that the TVT Secur and TVT were defective and caused her alleged injuries—specifically, urethral mesh erosions, dyspareunia, vaginal bleeding, abdominal pain, urinary tract infections, urinary problems (pain while urinating, retention, and difficulty emptying the bladder), recurrence of SUI, urge incontinence, and revision surgeries. Mr. Ebaugh asserts a derivative claim for loss of consortium. Ms. Ebaugh’s claimed injuries are all commonly known side effects of pelvic mesh surgery, and Ethicon had no duty to warn Ms. Ebaugh’s implanting surgeon, Dr. Paul Douglass, of conditions generally known to pelvic floor surgeons. Additionally, Dr. Douglass’s testimony confirms he already knew of the risks Ms. Ebaugh encountered which she attributes to the TVT and TVT Secur devices; he did not rely on the Instructions for Use (“IFU”) for either device; and there is no evidence that a different or additional warning would have caused him to change his prescribing decision to select these devices for Ms. Ebaugh. Plaintiffs have abandoned claims for failure-to-warn, fraud, and misrepresentation. Their remaining claims related to design defect fail because they are time-barred. Ms. Ebaugh had sufficient notice of a causal connection between her claimed injuries and the TVT Secur in June 2007 when Dr. Douglass told her that it had “failed” and needed to be replaced with the TVT. As to the TVT, Ms. Ebaugh had sufficient notice no later than June 14, 2011, but Plaintiffs did not file suit until more than two years later on July 3, 2013. These claims, as well as the ones for loss of consortium and punitive damages, also fail because either they are not recognized by Pennsylvania law or Plaintiffs cannot meet their burden of establishing the required elements. B. The Medical Condition at Issue – Stress Urinary Incontinence and Its Treatment Including the TVT Secur and TVT Devices SUI is the unintentional and uncontrolled leakage of urine caused by events creating intraabdominal stress, such as coughing, sneezing, lifting, exercise, and intercourse. SUI is a common problem for many women. SUI can significantly affect a woman’s physical and psychological quality of life, lead to social isolation and withdrawal from family and friends, and reduce an active lifestyle. Often, women will gain weight, suffer depression, and avoid intimacy. The TVT Secur device and its predecessor, the TVT device, are midurethral slings designed to treat SUI in an effective and durable way, allowing women to return to an active lifestyle. Before the development of midurethral slings, there was no one procedure that was the standard of care. Surgeons performed a variety of procedures in an attempt to correct SUI. These procedures included needle suspension procedures, Burch colposuspension, and the pubovaginal fascial sling, which uses a patient’s native tissues. 2 These earlier native tissue procedures required extensive and potentially harmful surgery with abdominal incisions, general anesthesia, hospital stays, and significant recovery times. Native tissue SUI surgeries are also associated with numerous complications, including wound complications, suture erosions, pain, dyspareunia, and voiding dysfunction, and are also prone to failure leading to reoperation. Mesh surgery also presents these complications, with the additional risk that tissue around the mesh will erode and leave mesh exposed in the urethra or vagina, but advantages of minimizing surgery and providing longer-lasting relief have made mesh surgery the preferred treatment. Introduction of the TVT device revolutionized SUI treatment. The TVT was introduced in 1998 after over a decade of study by pelvic surgeons and FDA clearance. The TVT device uses a synthetic mesh made of PROLENE®, a proprietary, polypropylene-based material. The TVT device is comprised of a 1.1 cm wide strip of macroporous, monofilament PROLENE® mesh covered in a protective sheath, which is attached to two stainless steel needles. Placement is performed through the vagina by means of a small incision. Following placement the sheath is removed, the small vaginal incisions are closed, the mesh tape is cut at the skin, and the two abdominal exit incisions are closed. This minimally invasive—or “ambulatory”—procedure takes about 30 minutes or less, can be accomplished under local anesthesia, allows for faster recovery, causes less tissue damage, has been studied more than any other SUI surgery, and is more effective, durable, and safer than the native tissue SUI repairs. See Ex. A, Marc Toglia, M.D. TVT General Report. The TVT quickly became and currently is the Gold Standard for first line surgical management of SUI, and the midurethral sling has been the preferred choice of SUI surgery by pelvic surgeons nationally and internationally for over 10 years. See Ex. B, AUGS and SUFU Position 3 Statement (published January 2014 and updated June 2016) at 2; Ex. C, Case-Specific Expert Report of Dr. Jaime Sepulveda at 13 (stating that the TVT “offers the prevailing clinical option to treat refractory urinary incontinence”); Ex. A, Dr. Toglia General Report at 16. Further scientific developments followed the success of the TVT device. Many pelvic surgeons desired and moved towards an even less invasive option than the minimally invasive TVT with the development and use of smaller single-incision transvaginal slings—like the TVT Secur—which does not have exit incisions, takes a shorter amount of time to implant, requires only local anesthesia, uses the same mesh as the proven TVT but in a shorter length (8 centimeters), and resulted in favorable outcomes. See Ex. D, TVT Secur General Expert Report of Jaime Sepulveda, M.D. The TVT Secur device was developed over several years and was cleared by the FDA on November 28, 2005. The FDA placed both TVT and TVT Secur in Class II based on prior work by its medical panels. It thus determined that the devices did not “present a potential unreasonable risk of illness or injury” which would have required placement in Class III. 21 U.S.C. § 360c(C). While a panel in 2011 questioned the evidence to support single incision slings like TVT Secur, and Ethicon stopped selling it in 2012, the FDA has never taken single incision slings out of Class II, and subsequent studies have shown that they are as safe and effective as multi-incision slings, especially after surgeons have learned the proper method of implantation. In March 2013, the FDA reiterated that the multi-incision midurethral slings such as TVT are safe and effective. They are currently considered to be safe, effective, suitable first-line surgical options by the 1 worldwide pelvic floor surgeon societies, organizations, and practice guidelines. 1 Recent examples include: 1) the June 2016 Position Statement on Mesh Midurethral Slings for Stress Urinary Incontinence endorsed by the American College of Obstetrics & Gynecology (ACOG), American Urogynecologic Society (AUGS), American Association of Gynecological 4 C. Ella Ebaugh’s Case 1. Dr. Douglass’s Training and Experience Dr. Paul Douglass, a now-retired gynecologist based in Pennsylvania, performed Ms. Ebaugh’s TVT Secur and TVT implant surgeries. Dr. Douglass attended Thomas Jefferson University Medical School and, upon graduation in 1970, did an internship and residency in obstetrics and gynecology at York Hospital in York, Pennsylvania. Ex. E, Dep. of Paul Douglass, M.D. (“Douglass Dep.”) 12:17-13:6, Oct. 18, 2016. While he was practicing medicine, Dr. Douglass was licensed to practice in the state of Pennsylvania and was board certified in obstetrics and gynecology. Id . at 12:1-9; 14:7-14. Throughout his medical career, Dr.