PRE-TRIAL MEMORANDUM Opposing Counsel: Lee Balefsky Kila Baldwin Kline & Specter, P.C

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.

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

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

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. Douglass implanted “close to a hundred or more”

TVT products (including TVT Secur and TVT-O). Id . at 151:11-19. Before Ms. Ebaugh’s surgeries in 2007, Dr. Douglass “probably had done in the neighborhood of 85, 90 by that point.”

Id . at 342:10-15. Dr. Douglass testified that he was not familiar with the IFU that accompanies the packaging for the TVT Secur and TVT products, shown to him at his deposition, and he did not recall whether he ever saw the IFU for either product. Id . at 24:3-8, 33:18-21, 221:1-8. He also testified that when recommending a product to his patients, rather than relying on the IFU, he would rely on his “experience and others,” including his review of medical literature, “to give the risks and benefits” to his patients. Id . at 221:9-22. With respect to Ms. Ebaugh, he relied on

Laparoscopists (AAGL), Society of Gynecologic Surgeons (SGS), and the Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU); 2) the 2015 ACOG & AUGS Practice Bulletin 155 – Urinary Incontinence in Women; 3) the 2015 Cochrane Review: Mid-urethral sling operations for stress urinary incontinence in women; 4) the 2014 International Urogynecologic Association (IUGA) Position Statement on Mid-Urethral Slings for Stress Urinary Incontinence; 5) the 2014 Systematic review, meta-analysis and Society of Gynecologic Surgeons (SGS) Practice Recommendations; and 6) the October 2013 American Urological Association (AUA) Position Statement on the Use of Vaginal mesh for the Surgical Treatment of SUI.

a “bucket of knowledge” in selecting TVT Secur and TVT, which included information learned from other physicians, his review of medical literature, the experience of his colleagues, and his own personal experience. Id . at 279:12-282:22.

Dr. Douglass also testified that at the time he implanted TVT Secur and TVT in 2007, he was independently aware of the risk of all injuries Ms. Ebaugh claims to have experienced:

Alleged Injury Dr. Douglass’s Knowledge of Potential Risk

Failure of the devices to treat her Id. at 300:7-22 (“Q: All right. With respect to the TVT SUI procedures, obviously, did you know that there was a potential that they might not work? A: Yes. . . . Q: In fact, was that something that you talked with Ms. Ebaugh about? . . . A: Yes. Q: All right. And when we say might not work, we mean that her incontinence might not be fixed? A: Exactly.”), 324:4-11, 334:4-13

Dyspareunia and abdominal pain Id. at 28:11-20, 154:22-155:21, 271:22-272:10 (“Q: . . . Even if rare, you were aware that there was a risk of pain with intercourse with these surgeries to correct SUI? A: Yes. Q: All right. Including the TVT? A: Yes. Absolutely. Yes.”)

Vaginal bleeding Id. at 323:16-324:3, 335:7-10

Incontinence and other urinary Id. at 111:21-112:5, 292:18-21, 301:1-12, 302:9-303:3, issues 324:12-20 (“Q: Okay. This inability to urinate, is that retention? A: Yes. Q: Okay. And that’s a risk you were aware of obviously since you talked about it? . . . A: Yes.”), 334:20-23, 335:2-6

Urinary tract infections Id. at 121:19-122:9, 335:7-10

Need for further surgery Id. at 303:6-17, 304:22-305:4 (“Q: All right. Ms. Ebaugh complains about having to have additional surgeries to take the mesh out. Is that something you were aware of before you did the surgery? A: That, yes, someone would have to take it out if that happened.”)

According to Dr. Douglass, surgical treatment of SUI using transvaginal mesh, including

TVT Secur and TVT, “was a groundbreaking procedure” that was “minimally invasive” and

“replaced a very difficult, long procedure” that required patients to stay in the hospital overnight.

Id . at 71:7-11. He further characterized it as “a miraculous advance in the treatment of urinary incontinence, stress incontinence.” Id . at 71:11-13. In selecting and recommending TVT Secur and TVT to Ms. Ebaugh, he believed the products’ benefits “far” outweighed the risks and that those products were the best options for her. Id . at 256:8-19, 354:10-15, 354:19-23. Dr.

Douglass also testified that it was a “no-brainer” that TVT became the “gold standard” for surgical treatment of SUI and for that reason selected it for Ms. Ebaugh. Id . at 298:10-299:19.

He still stands by his decision today to select and recommend TVT Secur and TVT for Ms.

Ebaugh. Id . at 354:16-18, 354:24-355:1. Dr. Douglass did not offer the Burch or Marshall-

Marchetti-Krantz (“MMK”) procedures because he was not performing those surgeries after the

TVT became available. Id. at 252:23-256:7. Also, an autologous fascia sling and laparoscopic or robotic Burch procedures were not options he offered to Ms. Ebaugh because he never performed them. Id. at 257:11-259:19.

2. Plaintiff Ella Ebaugh and Her Medical Treatment

(a) Implantation of TVT Secur and TVT (Dr. Douglass)

On November 11, 2004, Ms. Ebaugh reported to Dr. Douglass that she had been experiencing stress urinary incontinence (“SUI”) for many years. Id . at 197:12-199:2. On

February 23, 2005, Ms. Ebaugh was again seen by Dr. Douglass, this time for evaluation of mixed incontinence, including both urge incontinence and SUI symptoms. Ex. F, Deposition of

Ella Mae Ebaugh (“Ebaugh Dep.”) 203:14-204:6, Sept. 8, 2016; Ex. E, Douglass Dep. 207:17-

217:21.

Ms. Ebaugh’s urinary incontinence continued as discussed with Dr. Douglass at an outpatient visit on April 1, 2005. Ex. G, Apr. 1, 2005 Office Record. During that visit, Dr.

Douglass discussed implanting a TVT-O device for her SUI and advised her that risks associated

with that implant procedure included “bleeding, infection, tape erosion, inability to urinate” and that “[i]t might not work.” Ex. E, Douglass Dep. 164:9-22; Ex. G, Apr. 1, 2005 Office Record.

Ms. Ebaugh chose not to have the procedure at that time. Ex. E, Douglass Dep. 324:21-325:1.

Ms. Ebaugh then saw Dr. Douglass again on January 10, 2007 with complaints of continuing mixed incontinence. Ex. H, Jan. 10, 2007 Office Record. Approximately four months later, Dr. Douglass documented that Ms. Ebaugh had “significant” SUI with some urge issues, and this time they discussed both the TVT Secur and TVT devices to treat her SUI. Ex. I,

May 22, 2007 Office Record. Dr. Douglass informed her of the risks of urinary retention, failure to cure her SUI, bladder spasm, difficulty emptying the bladder completely, urge problems, infection, bleeding, and erosion of the tape through the urethra, vagina, and bladder. Id . Dr.

Douglass and Ms. Ebaugh then elected to proceed with the TVT Secur. Ex. E, Douglass Dep.

329:14-22. On May 31, 2007, Dr. Douglass implanted a TVT Secur device. Ex. J, Plaintiff Fact

Sheet § II(1), at 5.

Three weeks later, Ms. Ebaugh reported that she was continuing to experience urinary incontinence and Dr. Douglass recommended that because her TVT Secur “failed,” she undergo a follow-up procedure during which he would implant a TVT to treat her SUI. Ex. E, Douglass

Dep. 341:9-22; Ex. K, June 22, 2007 Office Record. During that visit on June 22, 2007, Dr.

Douglass told Ms. Ebaugh that the TVT was associated with the same risks as the TVT Secur, including erosion into the urethra, urinary retention, and failure of the device to treat her SUI.

Ex. E, Douglass Dep. 342:16-343:16. On July 12, 2007, he implanted a TVT device. Ex. J,

Plaintiff Fact Sheet § II(1), at 5; Ex. E, Douglass Dep. 343:19-24.

(b) Subsequent Treatment and Revision Surgeries (Drs. Mirsky, Wright, and Chai)

Ms. Ebaugh testified to first experiencing dyspareunia in 2007 when she attempted to have sexual intercourse with her husband after the implant surgeries. Ex. F, Ebaugh Dep. 61:4-

22. She continued to experience dyspareunia every time they attempted intercourse until following her eventual revision surgery in 2011. Id . at 60:10-16.

In visits to healthcare providers in February and March 2011, Ms. Ebaugh had complaints

of abdominal pain, dyspareunia, pelvic pain, vaginal itching and burning, leaking, urinary problems, and recurring urinary tract infections. Ex. L, Feb. 8, 2011 Office Record; Ex. M, Mar.

23, 2011 Office Record.

On April 26, 2011, she presented to Dr. Clyde Strang, a urologist, with complaints of

SUI, “discomfort with voiding, frequency and urgency.” Ex. N, Apr. 26, 2011 Office Record.

Dr. Strang performed a cystoscopy which revealed “a large piece of exposed TVT tape in the

mid urethra with a stone overlying it.” Id . Dr. Strang told Ms. Ebaugh “that [her] voiding

symptoms are probably related to the TVT tape eroding into the urethra.” Id . Mesh erosion is an

injury not found with non-mesh surgery.

He referred her to Dr. Howard Mirsky, another urologist, for possible revision surgery to

remove the mesh which had been exposed through the surrounding urethral tissue that had

eroded. Id .

On June 2, 2011, Ms. Ebaugh underwent a cystoscopy performed by Dr. Mirsky that

confirmed the urethral erosion. Ex. O, Dep. of Howard Mirsky M.D. (“Mirsky Dep.”) 43:15-22,

Nov. 3, 2016. At that time, Ms. Ebaugh was experiencing dyspareunia, pain when urinating,

urinary tract infections, bleeding, incontinence, and other voiding problems. Ex. J, Plaintiff Fact

Sheet § II(5), at 6; Ex. F, Ebaugh Dep. 56:21-24, 222:6-16, 240:20-23. Ms. Ebaugh testified that

at that visit, she was aware of her erosion and that Dr. Mirsky recommended revision surgery to remove the mesh in the urethra:

[A]nd he let me see the cystoscopy, and then that’s when we saw that the mesh had eroded through my urethra. And he said, I think I can go up there and snip that and everything will be okay.

Ex. F, Ebaugh Dep. 243:24-244:3.

On June 14, 2011, Dr. Mirsky performed a revision surgery at York Hospital in York,

Pennsylvania, during which he removed “[n]inety-eight percent” of the TVT. Ex. J, Plaintiff

Fact Sheet § II(5) at 6; Ex. O, Mirsky Dep. 44:1-8. Ms. Ebaugh and Dr. Mirsky both testified that the removal of the TVT mesh relieved her symptoms for up to six months. Ex. F, Ebaugh

Dep. 62:9-13 (“[W]hen he did his surgery where he snipped some mesh that had eroded through my urethra, after that six weeks, we had intercourse and it was wonderful. It did not hurt.”),

62:17-21 (stating that intercourse was then pain-free “[g]oing into 2012”); Ex. O, Mirsky Dep.

46:1-21, 54:13-56:3, 91:10-18 (testifying that removal of the mesh “resulted in resolution of pain and frequency and urgency and many of the symptoms and pain and discomfort she had prior to coming to see us”).

On March 14, 2012 and on March 1, 2016, Ms. Ebaugh underwent additional revision surgeries as a result of mesh erosions into her urethra, performed by Drs. Toby Chai and Edward

Wright, respectively. Ex. J, Plaintiff Fact Sheet § II(5), at 6.

II. STATEMENT OF RELIEF REQUESTED

Ms. Ebaugh seeks compensatory and punitive damages, including damages for lost wages and out-of-pocket expenses. See id . at § II(8)-(9), at 9. Although Ms. Ebaugh seeks punitive

damages, as described below, punitive damages are not available under New Jersey law, which

the parties agree applies to punitive damages, in this action. Additionally, Marvin Ebaugh

claims damages for loss of services of spouse, impaired sexual relations, and psychological/emotional injuries. Id. at § II(10)-(11), at 10.

III. SETTLEMENT EFFORTS

There have been no individual settlement discussions.

IV. WITNESSES

The Parties will exchange witness lists today, July 7, 2017. Ethicon reserves the right to

supplement its witness list as needed to rebut Plaintiffs’ direct testimony and to call for cross-

examination of any of the witnesses identified by Plaintiffs in their witness list.

V. EXPERTS

A. Plaintiffs’ Experts

Plaintiffs have identified seven expert witnesses: Daniel Elliott, M.D.; David Hopkins,

ASA, MAAA; Vladimir Iakovlev, M.D.; Professor Dr. Med. Uwe Klinge; Michael Margolis,

M.D.; Peggy Pence, Ph.D., RAC, FRAPS; and Bruce Rosenzweig, M.D. Ethicon deposed Drs.

Iakovlev and Margolis on April 2, 2017 and April 29, 2017, respectively. Plaintiffs have

noticed, and Ethicon has cross-noticed, the de bene esse deposition of Dr. Rosenzweig starting

on July 14, 2017. The remaining expert witnesses will not be deposed in this matter. Ethicon

filed motions to exclude the testimony of Drs. Elliott, Iakovlev, Klinge, Margolis, Pence, and

Rosenzweig, and those motions are fully briefed. There is potential for cumulative, duplicative

testimony between these experts.

B. Ethicon’s Experts

Defendants have identified nine expert witnesses: Elaine Duncan, M.S.M.E., RAC

(biomaterial science); Teri Longacre, M.D. (pathology); Steven MacLean, Ph.D, P.E. (polymer science and industry standards); Jaime Sepulveda, M.D. (urogynecology); Daniel Sexton, M.D.

(infectious disease); Marc Toglia, M.D., FACOG (urogynecology); Janet Tomezsko, M.D.

(urogynecology); Timothy Ulatowski, M.S. (regulatory); and Hannes Vogel, M.D.

(neuropathology). Plaintiffs have not requested the depositions of these experts.

VI. DISCOVERY & DEPOSITIONS

The key treating physicians were deposed on videotape, including Drs. Douglass, Mirsky,

Wright, and Chai. Deposition testimony from each of those physicians will be designated for use at trial. Additionally, the parties have exchanged extensive written discovery including document productions and interrogatories.

VII. EXHIBITS

The Parties will exchange exhibit lists today, July 7, 2017. Ethicon reserves the right to supplement its exhibit list with any documents produced in discovery by either side or by any third party prior to trial. Ethicon also reserves the right to supplement the exhibit list based on

Plaintiffs’ Pre-Trial Memorandum and based on any testimony offered by any witness that

Plaintiffs call at trial.

Ethicon also reserves the right to introduce any prior testimony or any exhibit from any deposition taken in this case and the right to use the prior testimony of any witness from or any exhibit used in any previous hearing in this case.

Ethicon also reserves the right to use and introduce additional exhibits for purposes of

impeachment or rebuttal, and to introduce or use any exhibit on Plaintiffs’ exhibit list.

VIII. ARGUMENT

Plaintiffs have abandoned the following claims in their Short Form Complaint (“SFC”):

Count II (strict liability – manufacturing defect), Count III (strict liability – failure to warn),

Count IV (strict liability – defective product), Count VI (fraud), Count VII (fraudulent

concealment), 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 (consumer protection), Count XIV (gross negligence),

Count XV (unjust enrichment). See SFC ¶ 12. Ethicon is entitled to judgment as a matter of law on these claims.

The only remaining claims that Plaintiffs continue to assert are Count I (negligence),

Count V (strict liability – design defect), Count XVI (loss of consortium), Count XVII (punitive damages), and Count XVIII (discovery rule and tolling). See SFC ¶ 12. For the reasons stated below and in Defendants’ Motion for Summary Judgment (which is fully briefed), each of these

claims fail as a matter of law. Should the pending Motion for Summary Judgment not be

granted, Ethicon plans to pursue disposition of these claims at trial based on the evidence presented.

A. Pennsylvania Law Governs All of Plaintiffs’ Claims Other than Punitive Damages.

Under Pennsylvania’s choice-of-law analysis, all of Plaintiffs’ claims, with the exception of punitive damages, are governed by Pennsylvania law. Plaintiffs have resided in Pennsylvania since at least 2000. Ex. J, Plaintiff Fact Sheet § I(4), at 2. Ms. Ebaugh was allegedly injured in

2007 when Dr. Paul Douglass implanted her with Ethicon’s TVT Secur and TVT devices at

Apple Hill Surgical Center in York, Pennsylvania. Id . § II(1), at 5. All of her subsequent relevant medical treatment occurred in Pennsylvania, with the exception of treatment in 2012 and

2016 with Dr. Toby Chai and Dr. Edward Wright in Maryland. Id . § II(5) & (6), at 6-9.

B. Plaintiffs’ Remaining Negligence and Strict Liability Claims Are Time-Barred.

The statute of limitations applicable to Plaintiffs’ remaining strict liability and negligence claims—is two years. See 42 Pa. Cons. Stat. § 5524(7); Rowland v. Novartis Pharmaceuticals

Copr. , 34 F. Supp. 3d 566 (E.D. Pa. 2014); Speicher v. Dalkon Shield Claimants Trust, 943 F.

Supp. 554, 557 (E.D. Pa. 1996). Under Pennsylvania’s discovery rule, a cause of action accrues

when a plaintiff has “‘inquiry notice’ that is tied to ‘actual or constructive knowledge of at least some form of significant harm and of a factual cause linked to another’s conduct, without the necessity of notice of the full extent of the injury, the fact of actual negligence, or precise cause.’” Gleason v. Borough of Moosic , 15 A.3d 479, 484 (Pa. 2011) (quoting Wilson v. El-

Daief , 964 A.2d 354, 364 (Pa. 2009)). Once a plaintiff has “the salient facts concerning the

occurrence of his injury and who or what caused it, he has the ability to investigate and pursue

his claim.” Ingenito v. AC & S, Inc. , 633 A.2d 1172, 1174 (Pa. Super. Ct. 1993) (internal

quotation marks omitted). “The party relying on the discovery rule bears the burden of proof,”

Rowland , 34 F. Supp. 3d at 566 (citing Wilson , 964 A.2d at 362), to show that she exercised

reasonable diligence to become informed of the facts and circumstances that form the basis of

the right to recovery and that she “was unable to discover the operative facts for [the] cause of

action [any] sooner.” Dreischalick v. Dalkon Shield Claimants Trust , 845 F. Supp. 310, 314-15

(W.D. Pa. 1994) (quoting Van Buskirk v. Carey Canadian Mines, Ltd. , 760 F.2d 481, 487 (3d

Cir. 1985)).

Here, Ms. Ebaugh possessed the “salient facts” concerning her claimed injuries and their

causal connection to her TVT Secur in 2007 when she was advised by her implanting surgeon

that the device had failed and he recommended a TVT implant. The recommendation that a

different device be used put her on notice that the design of TVT Secur might be defective because it had failed to cure her and another design was recommended.

She was on notice of her TVT claim no later than June 14, 2011, when Dr. Mirsky

removed the TVT mesh that had become exposed by erosion of the surrounding tissues. See supra at 10. By that date, Ms. Ebaugh had learned of the following facts related to her injuries

and their connection to her TVT Secur and TVT:

• The initial implantation of TVT Secur in 2007 was unsuccessful, and required her physician to implant a device with a different design, which put her on notice that it was the design of TVT Secur that triggered her initial problems.

• Through her discussions with Dr. Douglass in 2005 and 2007, she learned that use of TVT Secur and TVT was associated with the risks of urethral erosion, urinary retention, difficulty emptying her bladder completely, bleeding, and infection—all injuries that she is claiming were caused by her mesh products. See supra at 7-8.

• In April 2011, after conducting a cystoscopy that revealed a mesh erosion into Ms. Ebaugh’s urethra, Dr. Strang told her “that [her] voiding symptoms are probably related to the TVT tape eroding into the urethra.” See supra at 9.

• In early June 2011, Dr. Mirsky confirmed the urethral erosion with Ms. Ebaugh, and told her the TVT mesh that had been exposed should be excised, which would alleviate her dyspareunia, abdominal pain, and voiding difficulties. See supra at 9-10.

• On June 14, 2011, Dr. Mirsky removed the exposed mesh, which alleviated Ms. Ebaugh’s complaints for up to six months. See supra at 10.

• Erosion of mesh into the urethra is a complication associated with the use of mesh, and her experts in this case contend that all mesh is defective when used in the pelvic floor and that non-mesh surgery should have been performed instead. If non-mesh surgery had been performed, this signature injury would not have occurred.

These facts are sufficient to establish notice of a causal connection to trigger the statute

of limitations under Pennsylvania law. As such, the two-year period of limitations for her

complaint about TVT Secur began to run no later than June 2007. All claims related to that

device are thus time-barred, and any evidence related to TVT Secur should be excluded.

The limitations period for her TVT claims began to run no later than June 2011. See,

e.g. , Ingenito , 633 A.2d at 1175 (finding as a matter of law that the plaintiff’s statute of

limitations began to run when he was diagnosed with lung cancer, and was aware that he had a

history of exposure to asbestos). By June 2011, Ms. Ebaugh: (1) was aware of the urethral

erosion involving her TVT that was causing her dyspareunia and voiding problems; (2) was told by Dr. Mirsky that removal of the exposed mesh would alleviate her symptoms; (3) underwent

the recommended surgery to treat her symptoms; (4) experienced post-surgical relief of her symptoms for up to six months; and 5) now claims that no mesh should have been used to treat her incontinence. Accordingly, claims related to the TVT are also time-barred.

C. Plaintiffs’ Strict Liability – Design Defect Claim Also Fails Because Pennsylvania Law Does Not Recognize This Claim for Medical Devices.

Plaintiffs’ strict liability – design defect claim (Count V) fails as a matter of law because

Pennsylvania courts, applying comment k of the Restatement (Second) of Torts § 402A, do not recognize strict liability claims in cases involving prescription drugs and medical devices.

More particularly, comment k rules out product liability claims for devices that carry

inherent risks, such as those which accompany surgery, when an adequate warning has been

given, and here Plaintiffs have dropped their claim that the surgeon was not adequately warned.

Comment k makes the informed surgeon, not the jury, the judge of whether the risks of the

operation are justified.

The bedrock opinion, Hahn v. Richter , 673 A.2d 888, 889-90 (Pa. 1996), sets forth the

Pennsylvania Supreme Court’s sound analysis on this point—an analysis that has been

consistently followed by both Pennsylvania state and federal courts in both the prescription drug

and medical device contexts. See, e.g. , Creazzo v. Medtronic, Inc. , 903 A.2d 24, 31 (Pa. Super.

Ct. 2006) (extending Hahn to medical devices); Carson v. Atrium Med. Corp. , 191 F. Supp. 3d

473, 476-77 (W.D. Pa. 2016) (dismissing a hernia mesh plaintiff’s strict liability failure-to-warn claim on the grounds that Pennsylvania law does not recognize such a claim against a medical device manufacturer); McLaughlin v. Bayer Corp. , 172 F. Supp. 3d 804, 833 (E.D. Pa. 2016);

Krammes , 2015 WL 4509021, at *5; Cogswell v. Wright Med. Tech., Inc. , No. 15-295, 2015 WL

4393385, at *3 (W.D. Pa. Jul. 16, 2015); Wilson v. Synthes USA Prods. , 116 F. Supp. 3d 463,

467 (E.D. Pa. 2015); In re Zimmer Nexgen Knee Implant Prods. Liab. Litig. , No. 12-c-6279,

2015 WL 3669933, at *35-36 (N.D. Ill. June 12, 2015) (applying Pennsylvania law); Runner v.

Bard , 108 F. Supp. 3d 261, 266 (E.D. Pa. 2015); Terrell v. Davol , Civ. A. No. 13-5074, 2014

WL 3746532, at *5 (E.D. Pa. Jul. 30, 2014); see also Smith v. Howmedica Osteonics Corp. , Civ.

Action No. 17-1174, 2017 WL 1508992, at *2 (E.D. Pa. Apr. 27, 2017) (granting device

manufacturer’s motion to dismiss strict liability design defect claim under Pennsylvania law).

This principle is so well-settled that the Pennsylvania Suggested Standard Civil Jury

Instructions omit any instruction for strict liability claims from the Prescribed Drugs and Medical

Devices chapter and instead advise: “Pennsylvania courts have declined to apply strict liability in

cases involving prescription drugs and medical devices, in accordance with comment k to the

Restatement (Second) of Torts § 402A.” See Pa. Suggested Standard Civil Jury Instructions §

23.00 Subcommittee Note.

The Pennsylvania Supreme Court’s analysis in Hahn , relying on comments j and k to the

Restatement (Second) of Torts § 402A, applies equally to any medical product, including

medical devices, that is available only by prescription. See Creazzo , 903 A.2d at 31 (stating that

Pennsylvania courts “find no reason why the same rational[e] applicable to prescription drugs

may not be applied to medical devices” (citing Hahn , 673 A.2d at 890-91)).

Further, Pennsylvania takes a blanket approach to the application of comment k to

“unavoidably unsafe” products. See Lance v. Wyeth , 85 A.3d 434, 442 n.11 (“Others, however,

including Pennsylvania, have taken a blanket approach applying comment k to preclude strict-

liability design-defect claims for all prescription drugs.”); Cogswell v. Wright Med. Tech., Inc. ,

No. 15-295, 2015 WL 4393385, at *2 (W.D. Pa. July 16, 2015) (“[T]he law in Pennsylvania requires the Court to determine the application of comment k categorically, not to conduct a case-by-case analysis of each particular product.”) (applying comment k to a medical device);

Kee v. Zimmer, Inc. , 871 F. Supp. 2d 405, 410 (E.D. Pa. 2012) (“Even assuming that Plaintiff’s

argument that a case-by-case analysis is a ‘better course of action,’ this is not the law in

Pennsylvania.”). Comment k draws no distinction between the severity of the conditions that prescription products are designed to treat so long as those products are associated with

unavoidable medical risks. And a device that must be surgically implanted and carries with it a

known list of potential complications is a device that cannot be made completely safe. As TVT

Secur and TVT are implanted medical devices available only by a surgeon’s prescription, they

fall squarely within comment k, and are exempt from strict liability claims. Plaintiffs’ strict

liability – design defect claim (Count V) thus fails as a matter of law.

D. Plaintiffs’ Negligence Claim Based on Design Defect Also Fails.

Plaintiffs have abandoned any failure-to-warn claim, including under negligence. Instead, they are asserting a claim for negligent design, essentially asserting that the risks associated with the TVT Secur and the TVT so outweighed the benefits that Ethicon should have ceased marketing and selling the devices. See Pls.’ Resp. to Defs.’ Mot. for Summ. J. at 6-12, 33-34

(stating that the products’ risks “outweigh any potential benefits” and “defendants knew of the risks and complications associated with both devices, yet continued to market and sell them”).

Similar to the abandoned failure-to-warn claim, Plaintiffs cannot establish this negligent design claim under Pennsylvania law.

In Lance , the Pennsylvania Supreme Court stated that the duty of a prescription-product manufacturer under negligence “can be viewed on a continuum from the requirements of: a warning of dangers, through a stronger warning if justified by the known risks, through non- marketing or discontinuance of marketing when it becomes or should become known that the product simply should not be used in light of relative risks.” 85 A.3d at 459-60.

Where a plaintiff’s negligence theory of the case is that the product’s design is so unsafe that the product should not be used, she must prove that the manufacturer has “introduce[d] [the product] into the marketplace, or continue[d] a previous tender, with actual or constructive knowledge that the [product] is too harmful to be used by anyone.” Id. at 461. While the court in

Lance may have called into question the general requirement that a plaintiff establish a design defect through proof of a reasonable alternative design, the court noted that the negligence standard it adopted had limited applicability to prescription products that remain on the market:

We recognize that the application of Appellee’s theory of liability would present more difficult questions in a circumstance in which a prescription drug maintained its FDA approval, it remained on the market, and U.S. doctors continued to prescribe it. The assertion that no reasonable physician would prescribe the drug (knowing what the manufacturer knew or should have known) is capable of gaining greater traction when, as here, the inquiry is more in the nature of a post-mortem.

Id. at 457 n.33.

The court in Lance relied upon the Restatement (Third) of Torts: Products Liability §

6(c), which provides:

A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.

See Lance , 85 A.3d at 459. The comment to the Restatement provides that under this provision:

[A] drug is defectively designed only when it provides no net benefit to any class of patients. Courts have concluded so long as a . . . medical device provides net benefits to some persons under some circumstances, the . . . device manufacturer should be required to instruct and warn health-care providers of the foreseeable risks and benefits.

Restatement (Third) of Torts: Products Liability § 6 cmt. B. “Thus, a . . . medical device that has

usefulness to any class of patients is not defective in design even if it is harmful to other patients.” Id.

For several reasons, Plaintiffs cannot prevail on their negligence claim asserted under

Lance ’s “too harmful to be used by anyone” standard. First, as to Ms. Ebaugh’s TVT, Plaintiffs cannot establish a negligence claim under Lance because the device remains on the market and continues to be the gold-standard for the treatment of SUI. See Ex. B, AUGS and SUFU Position

Statement at 2; Ex. C, Dr. Sepulveda Case-Specific Report at 13; Ex. A, General Expert Report

of Dr. Marc Toglia at 16. The AUGS and SUFU Position Statement itself establishes that

midurethral slings, including TVT, are safe and highly effective for an overwhelming portion of patients with SUI:

Full-length midurethral slings, both retropubic and transobturator, have been extensively studied, are safe and effective relative to other treatment options and remain a leading option and current gold standard for stress incontinence surgery. Over 3 million MUS have been placed worldwide and a recent survey indicates that these procedures are used by > 99% of AUGS members.

Ex. B at 2. Dr. Douglass, the implanting surgeon, testified that it was a “no-brainer” that TVT became the gold standard for surgical treatment of SUI and for that reason selected it for Ms.

Ebaugh. See supra at 7. Given this evidence, Plaintiffs cannot demonstrate that Ms. Ebaugh’s

TVT was negligently designed under Lance , and this claim should be dismissed as to this device.

Second, while the design of TVT Secur need not be considered as that claim is barred by

the statute of limitations, Plaintiffs have failed to establish that at the time Dr. Douglass

implanted the TVT Secur in June 2007, Ethicon knew or should have known that the alleged

risks associated with the device were so significant that it should have discontinued its marketing

and selling as it should not have been implanted in any class of patients, as required by the Lance

standard. See 85 A.3d at 459-60. The evidence cited by Plaintiffs in their Response merely

shows that Ethicon received some complaints regarding mesh fraying, but does not demonstrate the level of constructive knowledge in 2007 required to state a claim under Lance . Recent studies show that TVT Secur’s efficacy is similar to that of TVT-O, further demonstrating that it was not unreasonable to continue marketing and selling the device. See Ex. P, Ana Maria H. M. Bianchi-

Ferraro, et al., Randomized controlled trial comparing TVT-O and TVT-S for the treatment of stress urinary incontinence: 2-year results , 25 INT . UROGYNECOL . J., 1343-1348 (2014) (similar

objective cure rate of 77% (TVT Secur) vs. 84% (TVT-O); similar subjective cure rate of 76%

(TVT Secur) vs. 80% (TVT-O)); Ex. Q, Giovanni A. Tommaselli, et al., Medium-term and long-

term outcomes following placement of midurethral slings for stress urinary incontinence: a systematic review and metaanalysis , INT . UROGYNECOL . J. (2015) (5 year data, similar objective cure rate of 69% (TVT Secur) vs. 83% (TVT-O); similar subjective cure rate of 64% (TVT

Secur) vs. 79% (TVT-O)). Further, the fact that Ethicon eventually removed TVT Secur from the market in 2012, almost five years after Ms. Ebaugh’s implant surgery (Pls.’ Resp. to Defs.’

Mot. for Summ. J. at 12), is irrelevant to the question of whether Ethicon had sufficient knowledge in June 2007 to meet the Lance standard.

Additionally, Dr. Douglass’s testimony regarding TVT Secur’s benefits and it being the best option for Ms. Ebaugh, in conjunction with his independent awareness of the risks and decision to still chose TVT Secur for her alone shows that Plaintiffs cannot demonstrate that in

June 2007, a reasonable health-care provider, knowing the foreseeable risks and benefits of TVT

Secur, would not have prescribed the device in any class of patients. See Restatement (Third) of

Torts § 6(c). Because Plaintiffs have abandoned their failure-to-warn claims, and have failed to present any evidence establishing that TVT Secur was unsafe for any patient at the time of Ms.

Ebaugh’s implant surgery, their negligent design claim fails. 85 A.3d at 459-60. This is

especially true when the clinical studies show that the problem with TVT Secur, if any, was an initial learning curve, and here there is no claim that the implanting surgeon lacked learning.

Moreover, to the extent Plaintiffs assert that under Lance , they can state a claim for

Ethicon’s failure to stop selling TVT Secur and TVT, that argument has been rejected by the

United States Supreme Court. Mut. Pharm. Co. v. Bartlett , 133 S. Ct. 2466, 2477-78 (2013).

The Court in Bartlett stated:

We reject this “stop-selling” rationale as incompatible with our pre-emption jurisprudence. Our pre-emption cases presume that an actor seeking to satisfy both his federal- and state-law obligations is not required to cease acting altogether in order to avoid liability. Indeed, if the option of ceasing to act defeated a claim of impossibility, impossibility pre-emption would be “all but meaningless.”

Id. at 2478; see also Trejo v. Johnson & Johnson , Case No. B238339, -- Cal. Rptr. 3d --, 2017

WL 2825803, at *21 (Cal. Ct. App. Second Dist. June 30, 2017) (“conclud[ing] that plaintiff’s

design defect claim that defendants should have withdrawn Motrin from the market is preempted

by the [Bartlett ] impossibility preemption analysis” noting “that a manufacturer may not be

required to stop selling a product in order to avoid a state products liability claim” (citing

Bartlett , 133 S. Ct. at 2477)).

E. Mr. Ebaugh’s Derivative Loss of Consortium Claim Fails.

Because Plaintiffs’ substantive claims are without merit, the loss of consortium claim

(Count XVI), which is derivative in nature, also fails as a matter of law. Patterson v. Am. Bosch

Corp. , 914 F.2d 384, 386 n.4 (3d Cir. 1990); Benjamin v. Fassnacht , 39 F. Supp. 3d 635, 646

(E.D. Pa. 2014), rev’d on other grounds , 801 F.3d 366 (3d Cir. 2015) (“It is true that a derivative

loss of consortium claim cannot be successful if a plaintiff cannot prevail on the underlying

claim as a matter of law.”).

F. Plaintiffs Cannot Establish Their Claim for Punitive Damages (Count XVII).

The parties agree that New Jersey law governs the issue of punitive damages. With respect to Plaintiffs’ punitive damages claim, the Court must evaluate the evidence these

Plaintiffs have put forth—regardless of what Philadelphia courts have ruled in other cases, with other plaintiffs, and in some cases, where different devices and arguments were before those courts. For instance, any reliance on Hammons , Carlino , and Beltz is irrelevant because those

cases all involved, at least in part, a punitive damages claim based on Ethicon’s failure-to-warn,

while Plaintiffs have abandoned such claims here. Any punitive damages claim in this case will

thus be decided on separate considerations.

To recover punitive damages under New Jersey law, Plaintiffs must prove by “clear and

convincing evidence” that Ethicon acted with “actual malice” or a “wanton and willful

disregard” for Ms. Ebaugh’s safety. N.J.S.A. § 2A:15-5.12(a). They may not satisfy their burden

with proof of negligence, including gross negligence. See id. Punitive damages in New Jersey are

“a limited remedy and must be reserved for special circumstances.” Maudsley v. State , 816 A.2d

189, 208-09 (N.J. Super. Ct. App. Div. 2003). An award of punitive damages is therefore improper “in the ordinary unaggravated tort case whether it be grounded on strict liability or fault.” Fischer v. Johns-Manville Corps. , 472 A.2d 577, 582 (N.J. Super. Ct. App. Div. 1984)

(quotation marks omitted).

The NJPLA defines “[a]ctual malice” as “an intentional wrongdoing in the sense of an evil-minded act.” N.J.S.A. § 2A:15-5.10. “Wanton and willful disregard” is a “deliberate act or omission with knowledge of a high degree of probability of harm to another and reckless indifference to the consequences of such act or omission.” Id.

In light of the high standard imposed by the Legislature, New Jersey’s courts consistently

reject punitive damages claims as a matter of law and, in doing so, repeatedly reaffirm the formidable burden borne by plaintiffs to put forth clear and convincing evidence of a defendant’s egregious conduct. See, e.g. , Pavlova v. Mint Mgmt. Corp. , 868 A.2d 322, 328-29 (N.J. Super.

Ct. 2005) (reversing denial of summary judgment and dismissing punitive damages claim because although defendant was negligent and could have better monitored its policy for limiting risk of fire presented by heaters on its premises by continually notifying new residents, that conduct did “not rise to the level of wanton and willful disregard of the likelihood, or high probability, of resultant serious harm”). 2

Plaintiffs cannot establish their punitive damages claim for two reasons.

1. Plaintiffs Cannot Show that They Are Entitled to Punitive Damages on Their Design Defect Claim.

In 1988, the FDA determined that surgical mesh was a Class II device because of its long history of safe and effective use. The mesh from which both TVT and TVT Secur are made— modified PROLENE* mesh—was a Class II, not a Class III, device that had been on the market for the repair of hernia and other fascial deficiencies for eleven years (since 1996) prior to Ms.

Ebaugh’s implantation. Although the FDA cleared TVT to be marketed for a new indication in

2 See also Parks v. Pep Boys , 659 A.2d 471, 478 (N.J. Super. Ct. App. Div. 1995) (reversing denial of summary judgment and dismissing punitive damages claim because although defendant’s sale of freon to teenagers could be viewed as negligent or grossly negligent, it was neither malicious nor wanton and willful); Allendorf v. Kaiserman Enters. , 630 A.2d 402, 403- 04, 409 (N.J. Super. Ct. App. Div. 1993) (affirming summary judgment dismissing punitive damages claim by Ms. Ebaugh injured by defective elevator door, notwithstanding evidence of conduct that included mechanic’s purposeful manipulation of door’s electric eye and failure to notify anyone in building that he adjusted it); Villa Enters. Mgmt. Ltd. v. Fed. Ins. Co. , 821 A.2d 1174, 1188 (N.J. Super. Ct. Law Div. 2002) (holding that although insurer did not ultimately prevail in its position, it did not act with a willful or wanton disregard of its insured’s legal rights where no reported decisions in New Jersey addressed scope of advertising injury coverage); accord Kane v. U-Haul Int’l, Inc. , 218 F. App’x 163, 167 n.3 & accompanying text (3d Cir. 2007), cert. denied , 552 U.S. 1009 (2007); Di Giovanni v. Pessel , 260 A.2d 510, 511 (N.J. 1970); Grossman v. Club Med Sales, Inc. , 640 A.2d 1194, 1196-97, 1200 (N.J. Super. Ct. App. Div. 1994); Bencivenga v. J.J.A.M.M. , Inc. , 609 A.2d 1299, 1300-02, 1305 (N.J. Super. Ct. App. Div.), cert. denied , 617 A.2d 1220 (N.J. 1992) (table).

1998 (i.e., the treatment of stress urinary incontinence), it had been on the market for that indication for 9 years prior to Ms. Ebaugh’s implantation. The adverse events associated with the use of pubourethral slings for the treatment of stress urinary incontinence were well known.

Marketing TVT, a device made from Class II surgical mesh, whose Class II predicate device had been successfully used for 11 years, and the device itself had been used for 9 years for the same indication for which Ms. Ebaugh was treated, is not “reckless indifference” or “willful” or

“wanton” conduct. The FDA’s placement of the device in Class II meant that it had determined there was no “potential unreasonable risk of illness or injury.”

Likewise, TVT Secur’s predicate devices—TVT and TVT-O—were Class II, not

Class III, devices for the treatment of stress urinary incontinence that had been on the market for nine years (TVT, since 1998) and four years (TVT-O, since 2003) before Ms. Ebaugh’s implantation for the same condition. 3 As with TVT, marketing TVT Secur, a device made

from Class II surgical mesh, whose Class II predicate devices had been successfully used for

nine and four years, respectively, for the same indication for which Ms. Ebaugh was treated,

is not “reckless indifference” or “willful” or “wanton” conduct. In fact, even today, single

incision slings like TVT Secur remain in Class II and have not been put into Class III.

Plaintiffs’ experts criticize the mesh used in TVT Secur and TVT, but there is no mesh on the market today used for incontinence that is both lighter weight and larger pore than the mesh used in those devices. Johnson & Johnson v. Batiste , No. 05-14-00864-CV,

2015 WL 6751063, at *5 (Tex. Ct. App., Dallas Div. Nov. 5, 2015) (stating that “there was

3 The only differences between TVT Secur and its predicates TVT and TVT-O were (1) it is a less invasive “exit less device” that enables the physician to perform the suburethral sling procedure placing the mesh under the mid urethra without either the delivery device or the implant exiting the skin; and (2) the ends of the mesh are sandwiched between layers of absorbable material.

no evidence that any mid-urethral synthetic sling sold in the United States has a lighter weight, larger-pore mesh than the TVT–O”). They claim that a lighter mesh such as Vypro or a partically absorbable mesh such as Ultrapro should be used, but they have never tested a

TVT Secur or TVT made of those meshes, the FDA has never cleared them for incontinence use, and the FDA in fact refused to clear a partially-absorbable mesh for that purpose.

Because they have conducted no tests, they cannot say such a device would be effective and would not cause other complications. And their experts disagree, which in itself should be fatal to their case in Pennsylvania.

2. Conclusory Allegations About Ethicon’s Purported Conduct Do Not Satisfy New Jersey’s Standards for Punitive Damages.

Plaintiffs have no evidence to satisfy the demanding standard imposed by New Jersey law on their design defect claim. Setting aside the fact that the TVT Secur and TVT were made from surgical mesh classified as Class II based upon a long history of safe and effective use,

Plaintiffs offer mere conclusory statements about Ethicon’s purported conduct.

Further, the MDL court has refused to allow punitive damages to go to the jury in a previous

TVT case, Lewis v. Ethicon, No. 2:12-cv-04301, Ex. R, Trial Tr. at 63:13-16 (S.D.W. Va. Feb. 8,

2014) (“there wasn’t any evidence that would support a punitive damage award”), and in a TVT-O case, Huskey v. Ethicon, No. 2:12-cv-05201, Ex. S, Trial Tr. at 114:25-115:3 (S.D.W. Va. Aug. 29,

2014). Plaintiffs’ evidence here will be no better.

Under the circumstances here, Plaintiffs cannot meet their burden of proving by clear and convincing evidence that Ethicon acted with actual malice or a wanton and willful disregard for

Ms. Ebaugh’s safety.

IX. AFFIRMATIVE DEFENSES

A. The Learned Intermediary Doctrine Applies

Pennsylvania recognizes the learned intermediary doctrine with respect to prescription medical devices. See Creazzo , 903 A.2d at 31-32; McLaughlin v. Bayer Corp. , 172 F. Supp. 3d

804, 831 (E.D. Pa. 2016). Under this doctrine, a device manufacturer’s duty to warn extends to the physician, not the patient. Lance , 85 A.3d at 438 n.6. While Plaintiffs have abandoned their failure-to-warn claims, Ethicon reserves the right to assert the learned intermediary doctrine as needed at trial.

B. Plaintiffs’ Claims Are Barred by the Statute of Limitations

As explained in Section VIII(B) above, Plaintiffs’ claims are barred by the statute of limitations.

Dated: July 7, 2017 /s/ Melissa A. Merk Kenneth A. Murphy Melissa A. Merk Molly E. Flynn DRINKER BIDDLE & REATH LLP One Logan Square, Suite 2000 Philadelphia, PA 19103-6996

Julie A. Callsen TUCKER ELLIS LLP 950 Main Avenue, Suite 1100 Cleveland, Ohio 44113-7213

Phillip J. Combs (admitted pro hac vice ) THOMAS COMBS & SPANN PLLC 300 Summers Street, Suite 1380 Charleston, WV 25301

Kim M. Schmid (admitted pro hac vice ) BOWMAN AND BROOKE LLP 150 South Fifth Street, Suite 3000 Minneapolis, MN 55402

Nils Burton Snell BUTLER SNOW LLP 500 Office Center Drive, Suite 400 Fort Washington, PA 19034 Telephone: (267) 513-1884 Facsimile: (267) 513-1701

Attorneys for Defendants Ethicon, Inc. and Johnson & Johnson

CERTIFICATE OF SERVICE

I hereby certify that, on July 7, 2017, I caused a true and correct copy of Defendants

Ethicon, Inc. and Johnson & Johnson’s Pre-Trial Memorandum to be served via electronic mail on counsel of record, as follows:

Lee Balefsky Kila Baldwin Michael Cavaliere Christopher Gomez Tracie Palmer Elia Robertson Kline & Specter, P.C. 1525 Locust St., 19th Flr. Philadelphia, Pa. 19102 Attorneys for Plaintiffs

/s/ Melissa A. Merk Melissa A. Merk