Carter v. Johnson & Johnson

• Court: District Court, D. Nevada
• Decided: May 23, 2022
• Docket: 2:20-cv-01232
• Status: Unknown

Opinion

1 WETHERALL GROUP, LTD. KAEMPFER CROWELL Peter C. Wetherall (NV No. 04414) Robert McCoy, No. 9121 2 9345 W. Sunset Road, Suite 100 Sihomara L. Graves, No. 13239 Las Vegas, NV 89148 1980 Festival Plaza Drive, Suite 650 3 (702) 838-8500 Las Vegas, Nevada 89135 4 Fax: (702) 837-5081 Telephone: (702) 792-7000 Email: Facsimile: (702) 796-7181 5 pwetherall@wetherallgroup.com Email: rmccoy@kcnvlaw.com Email: sgraves@kcnvlaw.com 6 7 WAGSTAFF & CARTMELL LLP BUTLER SNOW, LLP 8 Thomas P. Cartmell (Pro Hac Vice) Anita Modak-Truran (Pro Hac Vice) Diane K. Watkins (Pro Hac Vice) Jin Yoshikawa (Pro Hac Vice) 9 Nate Jones (Pro Hac Vice) 150 3rd Avenue South, Suite 1600 4740 Grand Avenue, Suite 300 Nashville, Tennessee 37201 10 Kansas City, MO 64112 Telephone: (615) 651-6751 11 (816) 701-1100 Facsimile: (615) 651-7100 Fax: (816) 531-2372 Email:anita.modak- 12 Email: tcartmell@wcllp.com truran@butlersnow.com Email: dwatkins@wcllp.com Email: jin.yoshikawa@butlersnow.com 13 Email: njones@wcllp.com 14 Counsel for Plaintiffs Counsel for Defendants Johnson & 15 Johnson and Ethicon, Inc. 16 17 UNITED STATES DISTRICT COURT 18 DISTRICT OF NEVADA 19 TAMARA CARTER and DAVID Case No. 2:20-cv-01232-KJD-VCF CARTER, 20 Plaintiffs, JOINT PRETRIAL ORDER 21 vs. 22 JOHNSON & JOHNSON; ETHICON, 23 INC.; and ETHICON LLC, KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 Defendants. After pretrial proceeding in this case, 2 IT IS ORDERED: 3 4 I. NATURE OF ACTION 5 This is a products liability action involving two prescription medical 6 devices – Prolift and TVT. On July 23, 2010, at St. Rose Dominican Hospital – San 7 Martin Campus in Las Vegas, Nevada, Dr. Gregory Hsieh implanted a Prolift device 8 for Tamara Carter’s posterior pelvic prolapse and a TVT mid-urethral sling for Mrs. 9 Carter’s stress urinary incontinence (“SUI”). Mrs. Carter alleges that these medical 10 11 devices caused her injuries and that Defendants are liable under claims of strict 12 liability for failure to warn and design defect. Her husband David Carter raises a 13 loss of consortium claim. Additionally, Plaintiffs claim that Defendants’ conduct 14 was malicious, oppressive, willful, wanton, reckless, or grossly negligent, and 15 therefore, an award of punitive damages is appropriate. Defendants deny Plaintiffs’ 16 allegations and assert that Prolift and TVT were state of the art at the time of implant, 17 18 Mrs. Carter’s alleged injuries pre-dated her surgery on July 23, 2010, Mrs. Carter 19 assumed the risks, and Mrs. Carter’s actions contributed to her injuries.1 20 A. PLAINTIFFS’ CONTENTIONS 21 1. The Prolift Device 22 23 1 Plaintiffs assert that the only affirmative defense permitted in this case is assumption of risk. See KAEMPFER CROWELL Young’s Mach. Co. v. Long, 100 Nev. 692, 694 (1984). 1980 Festival Plaza Dri2ve 4 1 The Prolift was designed to treat pelvic organ prolapse (“POP”). Prolapse 2 occurs when the body’s support for the bladder, rectum, intestine and/or uterus is

3 weakened, allowing an organ to bulge/drop into the vagina. The Prolift procedure 4 involves the insertion of a massive mesh implant with large mesh arms that extend 5 down into the depths of the pelvis, ostensibly to provide support for the prolapsed 6 organ(s). Because Mrs. Carter suffered from rectocele (rectal prolapse), her 7 8 surgeon chose to implant the Prolift posteriorly into the vagina. As designed by 9 Ethicon, the mesh implants were held in place by the insertion of mesh arms 10 attached as part of the implants. These arms, as well as the remainder of the mesh 11 implants, are implanted through the TVM technique developed by Ethicon and 12 marketed by Ethicon as part of the Prolift kit. The TVM technique, short for 13 transvaginal mesh, required the introduction of the mesh into the body through the 14 15 vagina and then pulling the mesh arms and remainder of the implant through the 16 vagina and into place in the spaces between the vagina and the bladder or the 17 rectum. This technique, marketed as an “innovative” and “tension free” technique, 18 held the implant in place by leaving the arms extending through many different 19 anatomical structures within the pelvis, including anatomical areas that had no 20 defect or weakness whatsoever, by use of large, sharp trocars. The mesh arms were 21 22 then pulled out through skin incisions, where they were trimmed at the level of the 23 skin. KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 Ethicon ignored safety and efficacy concerns with the Prolift when bringing 2 it to market, as Ethicon’s goal was to get the device to market as quickly as

3 possible. That is, Ethicon was pursuing what it perceived to be a market of 4 hundreds of millions of dollars and was in a race since its competitor American 5 Medical Systems (“AMS”) was getting to the market first with similar competitive 6 prolapse mesh kits, known as the Apogee and Perigee. In its rush to take this 7 8 product to market, Ethicon failed to properly test this TVM technique, with this 9 size and shape of implant, actually implanted through the vagina, a clean- 10 contaminated environment, leaving the implant contaminated after it was in the 11 body. 12 Very soon after the Prolift was released, Ethicon began to accumulate data 13 and information provided by surgeons regarding Prolift mesh and procedure 14 15 complications – including particularly intractable, untreatable pain and dyspareunia 16 (painful sexual intercourse). In addition, Ethicon also began to accumulate more 17 data regarding erosions and exposures of mesh after implantation as well as 18 contraction, bunching, and roping of the mesh leading to further pain and other 19 remote complications many years after implantation. This led Ethicon to develop 20 and market the Prolift +M – a product Defendants billed as a more “natural” and 21 22 thus a safer alternative. The Prolift +M was the same Prolift procedure and 23 instruments (trocars), but the mesh used was partially absorbable. (+M signifies the KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 Monocryl component – which was absorbable.) The goal of the Prolift +M was to 2 leave less mesh material, with larger pores and lighter weight, in a woman’s body,

3 and consequently reduce the inflammatory reaction, resulting scarring, and other 4 complications. Ultimately, Ethicon ceased marketing and selling the Prolift and 5 Prolift +M. Ethicon also changed the warnings (indications) for the Gynemesh PS 6 (Prolift’s predecessor) to indicate for abdominal placement only, not vaginally any 7 8 longer, as of September 1, 2012. 9 2. The TVT Device 10 The TVT mesh device was designed to treat stress urinary incontinence in 11 women. Like the Prolift mesh, the TVT mesh is made of polypropylene, with 12 other additives, plus tools to aid with implantation. The mesh is mechanically cut 13 14 from large sheets of polypropylene and, thus, the mesh frays and has sharp edges, 15 and pieces of the mesh fall off when tension is applied to the mesh. It ropes, curls, 16 and deforms when any amount of tension is applied. According to Ethicon’s own 17 internal documents, the mesh was initially designed as a hernia mesh in the 1970s 18 and is a heavyweight mesh with small pores. The heavy nature of the mesh 19 combined with the defects in the design of the TVT – including the fact that it 20 degrades, deforms, frays, ropes, curls and has sharp edges – lead to excessive 21 22 inflammation, scarring, and contraction of the mesh when implanted. Like the 23 Prolift, the effect of these defects are magnified because the TVT is implanted KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 through a woman’s vagina and into her pelvic tissue. Because the mesh and the 2 pelvic tissue surrounding it become stiff and brittle over time, the TVT causes

3 injuries including, but not limited to, chronic pain syndrome, pain with sex, urinary 4 dysfunction, and erosions into tissues and organs. Ethicon experienced excessive 5 complications in hernia patients with the old construction mesh it chose for the 6 TVT, and its own consultants warned that the use of the heavyweight, small-pore 7 8 mesh would increase the foreign body response, scarring, and complications if 9 used anywhere in the body. Nevertheless, Ethicon has continued to use the old 10 construction mesh in the TVT. 11 The early studies Ethicon relied on for its claims that the TVT is safe and 12 effective were performed by the inventor and other paid consultants with a 13 personal financial stake in the outcome of the studies, and Ethicon never verified 14 15 the data from the studies. Ethicon, itself, never studied the TVT in women before 16 launching the product onto the market and never asked independent investigators 17 to do so either. 18 Following launch, adverse event reports related to the TVT began to pour in, 19 including but not limited to complaints of erosions into nearby organs, pain 20 including chronic, debilitating pain, urinary dysfunction, bleeding, dyspareunia, 21 22 sexual dysfunction, and other injuries. Ethicon admits that all of these 23 complications were known to it at the time the TVT was launched. Yet, many of KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 these complications were downplayed in Ethicon’s published studies, instructions 2 for use, marketing materials, and sales aids to physicians and patients.

3 It is undisputed that the mesh used in the TVT product is the “old 4 construction” hernia mesh developed by Ethicon in 1974. It is also undisputed that 5 Ethicon continued to use this heavyweight, small pore mesh even after Ethicon had 6 access to safer mesh and even though Ethicon knew that the mesh construction 7 8 caused it to rope, curl, deform, lose particles and to have sharp, frayed edges. By 9 the early 2000s, Ethicon had access to lighter weight, larger pore, heat sealed 10 meshes that were much safer for patients, yet for marketing and business reasons 11 they continued selling the old construction mesh in the TVT. 12 3. Mrs. Carter’s Implants and Injuries 13 On July 23, 2010, Mrs. Carter underwent surgery, during which Dr. Hsieh 14 15 implanted a Prolift to treat her posterior pelvic organ prolapse and a TVT to treat 16 her SUI. At that time, the product labels warned only of general surgical 17 complications, but not novel Prolift and TVT-related complications (as discussed 18 in greater detail below). At the time that Dr. Hsieh implanted the devices into Mrs. 19 Carter, he was unaware that the Prolift mesh could rope or curl or that there could 20 be a chronic foreign body reaction from the mesh in the Prolift and TVT. 21 22 Dr. Hsieh has testified that he relied on the devices’ instructions for use and passed 23 those risks along to his patients. KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 Following the implantation of the Prolift and TVT devices, Mrs. Carter 2 experienced multiple mesh erosions, chronic pain, and other injuries. On October

3 31, 2011, Mrs. Carter returned to Dr. Hsieh and was found to have an erosion at 4 the posterior vaginal wall, which was tender to palpation. On November 30, 2011, 5 Dr. Hsieh trimmed the mesh exposure in the office. On December 21, 2011, Mrs. 6 Carter returned to Dr. Hsieh with complaints of heavy vaginal bleeding after sex 7 8 and feeling mesh in the vagina. On exam, mesh erosion was again noted. As a 9 result, on January 6, 2012, Dr. Hsieh took Mrs. Carter back to the operating room 10 and performed a mesh extrusion repair. In May of 2012, Mrs. Carter presented 11 with complaints of mesh exposure, vaginal pain, and bleeding. An exam 12 demonstrated a mesh exposure on the posterior vaginal wall. Consequently, Mrs. 13 Carter again underwent surgery to remove to portions of the mesh on September 14 15 27, 2012. Thereafter, an additional mesh erosion was noted on February 6, 2013. 16 Unfortunately, her chronic pelvic pain persisted, and another mesh exposure was 17 seen on October 31, 2014, which required an additional mesh excision surgery on 18 January 6, 2015. Mrs. Carter was returned to the operating room to repair another 19 area of exposed posterior mesh on May 26, 2015. Mrs. Carter had an additional 20 surgical procedure on July 23, 2015 for the treatment of her recurrent SUI with an 21 22 autologous fascial sling. 23 KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 At the present time, portions of the Prolift and TVT mesh remain in Mrs. 2 Carter’s pelvic musculature and currently cause, and will continue to cause,

3 chronic pain and other injuries. Mrs. Carter continues to suffer severe pain and 4 complications from her Prolift and TVT implants, including, but not limited to, 5 pelvic pain, pelvic floor myalgia, dyspareunia, and emotional injuries, which will 6 likely be lifelong. 7 8 Regarding Plaintiffs’ claims in this case, they assert the following causes of 9 action: 10 1. Design Defect 11 Plaintiffs will present evidence of numerous design defects that rendered the 12 Prolift and TVT unreasonably dangerous for their intended uses, including, but not 13 limited to, the following: 14 15 1. The polypropylene material used in the mesh causes a chronic foreign 16 body reaction that leads to adverse reactions and injuries; 17 2. The mesh degrades and fragments over time; 18 3. The mesh “creeps” or gradually elongates and deforms when placed 19 under tension within the body; 20 4. The mesh causes scar plate formation; 21 22 5. The Prolift and TVT as designed cannot be safely placed for several 23 reasons, including: KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 a. The placement occurs through a “clean contaminated” space, 2 meaning the devices are inserted into and through an area of the body with

3 high levels of bacteria that adhere to the mesh, causing immune reactions 4 and subsequent tissue breakdown and adverse reactions and injuries; 5 b. The procedure requires tensioning of the mesh at placement; 6 and 7 8 c. There is no way to place the device without causing an intense 9 foreign body reaction and fibrotic bridging in the pelvis;2 10 6. There is no safe, effective procedure for removal of the Prolift and 11 TVT when needed and the Prolift mesh cannot be entirely removed; 12 7. The mesh is small pore; 13 8. The mesh is heavyweight; 14 15 9. The mesh is too rigid/inflexible/inelastic; 16 10. The mesh shrinks and contracts following placement; 17 11. The mesh causes vaginal erosion, extrusion, inflammation, and 18 infection; 19 12. The mesh causes chronic tissue inflammation; 20 21 22 2 Additionally, the Prolift as designed cannot be safely placed because the placement procedure 23 is “blind” and the arms of the mesh are placed with trocars through the muscles. KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 13. The mesh entraps the nerves; and 2 14. The mesh causes chronic, permanent, debilitating pain.

3 Plaintiffs will also present evidence that these design defects existed at the 4 time the Prolift and TVT devices left Defendants’ control, that Defendants failed to 5 adequately test and/or perform appropriate clinical studies on the devices before 6 marketing and selling it for implantation in human beings, that the Prolift and TVT 7 8 devices were used in a manner which was reasonably foreseeable by Defendants, 9 and that the defective design of the Prolift and TVT caused Plaintiffs’ injuries and 10 damages. 11 Lastly, although safer alternative design is not a required element under 12 Nevada law, at the time the Prolift device was implanted in Mrs. Carter the 13 following safer alternative designs and procedures existed: 14 15 1. Abdominally placed mesh; 16 2. Colporrhaphy and native tissue repair; 17 3. Sacrocolpopexy; 18 4. Larger pore, lighter weight mesh; 19 5. Mesh without arms and without use of trocars. 20 At the time the TVT device was implanted in Mrs. Carter, the following 21 22 safer alternative designs and procedures existed: 23 1. Surgical repairs using sutures instead of mesh (e.g., Burch procedure); KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 2. Autologous fascia slings; and 2 3. Allograft slings.

3 2. Failure to Warn 4 Plaintiffs will present evidence that Defendants failed to adequately warn 5 Plaintiff and her treating physicians of the dangers and risks caused by and/or 6 associated with the Prolift and TVT that were known or should have been known 7 8 to Defendants, including the following: 9 1. pelvic pain; 10 2. vaginal pain; 11 3. groin pain; 12 4. pelvic pain syndrome; 13 5. painful intercourse; 14 15 6. mesh banding and hardening; 16 7. recurrent prolapse; 17 8. degradation, fragmentation and/or “creep;” 18 9. excessive contraction and shrinking; 19 10. balling and bunching of mesh; 20 11. mesh folding; 21 22 12. vaginal shortening; 23 13. inability to remove the mesh entirely, and potential need for multiple KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 removal surgeries; 2 14. increased inflammatory tissue response;

3 15. permanent, chronic, debilitating pain; 4 16. the rate and manner of mesh erosion; 5 17. that devices should not be placed in sexually active women; 6 18. use of the devices exposes patients to a greater risk of future surgeries; 7 8 19. the lack of elasticity of the mesh; 9 20. the complications and consequences of the foreign body reaction 10 caused by the mesh; and 11 21. the Prolift was rushed to market against the wishes of Defendants’ 12 consultants and employees. 13 Defendants further failed to warn patients and physicians of the lack of 14 15 efficacy of the Prolift device implanted in Plaintiff. More specifically, Defendants 16 failed to warn that treatment of pelvic organ prolapse with Prolift is no more 17 effective than feasible available alternatives and exposes patients to a greater risk 18 of adverse events/injuries than those alternatives. 19 Lastly, Plaintiffs will present evidence that Plaintiffs’ injuries and damages 20 caused by the Prolift and TVT were foreseeable to Defendants, and that 21 22 Defendants’ inadequate warnings, information, and instructions proximately 23 caused Plaintiffs’ injuries and damages, as Mrs. Carter’s implanting physician KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 would have been able to give proper informed consent to Mrs. Carter, who would 2 not have undergone implantation of the Prolift and TVT if informed of any of the

3 dangers and risks associated with the devices. 4 3. Loss of Consortium 5 Plaintiff David Carter asserts a loss of consortium claim, as the injuries 6 caused by Defendants’ products have deeply impaired all facets of his relationship 7 8 with his wife. Plaintiffs will present evidence of Plaintiff David Carter’s loss of 9 consortium at trial. 10 4. Punitive Damages 11 In general, Plaintiffs’ punitive damages claim is based on the following 12 categories of conduct by Defendants evidencing deliberate disregard for the rights 13 and safety of others: 14 15 1. Defendants failed to perform multiple necessary tests prior to selling 16 the Prolift and TVT devices; 17 2. Multiple physicians, consultants, and employees warned Defendants 18 of design defects in and complications and injuries caused by the Prolift and 19 TVT, and Defendants chose to ignore those warnings and sell the products 20 without properly testing or studying them first; 21 22 3. Multiple physicians, consultants, and employees warned Defendants 23 of the need for a different mesh material to be used in the Prolift and TVT KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 prior to and after being placed on the market, and Defendants chose to 2 ignore those warnings and sell the products without properly testing or

3 studying them first; 4 4. Employees and consultants of Defendants warned of the need to add 5 warnings to the Instructions for Use (“IFU”) and patient brochure, and 6 Defendants chose not to do so; 7 8 5. Defendants blatantly and knowingly misled and made false statements 9 to physicians and the public about the efficacy of the devices and 10 complications caused by the devices, as well as concealed information about 11 the efficacy of the devices and complications caused by the devices from 12 physicians and the public, resulting in injury to thousands of women, 13 including Plaintiff; 14 15 6. Defendants chose not to warn physicians of numerous, chronic, 16 debilitating complications and injuries caused by the Prolift and TVT 17 devices despite knowing the devices caused those complications and 18 injuries; 19 7. Defendants placed profits over patient safety, resulting in serious 20 injury to Plaintiff and thousands of other women; 21 22 8. Despite Defendants’ awareness of the numerous defects in the Prolift 23 and TVT devices, and the serious injuries caused to women such as Plaintiff KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 by the devices, Defendants continued to sell the Prolift until 2012, when it 2 was finally removed from the market, and continued to sell the TVT.

3 B. DEFENDANTS’ CONTENTIONS 4 Defendants deny Plaintiffs’ allegations. Ethicon’s Prolift and TVT products 5 are prescription medical devices that were state of the art at the time of implant, were 6 properly designed for pelvic surgeons, like Dr. Gregory Hsieh who implanted the 7 8 devices, and had adequate warnings. 9 There is no defect in either of these products that caused Mrs. Carter’s alleged 10 injuries. Mrs. Carter’s alleged injuries pre-dated her surgery on July 23, 2010 and 11 were exacerbated by her long history of nicotine and substance abuse, including drug 12 seeking behavior for narcotics and pain medications. Her quality of life prior to July 13 23, 2010, included significant chronic pain and debilitating mental health problems. 14 15 1. The Products 16 a. Prolift 17 Prolift is a mesh device used to surgically manage pelvic organ prolapse, 18 which is the abnormal descent or herniation of pelvic organs, such as the bladder, 19 rectum, colon and uterus, from their normal attachment sites in the pelvis. The 20 prolapse happens when the pelvis muscles and tissues can no longer support these 21 22 organs, causing a woman to experience vaginal pressure, pelvic pain, urinary 23 problems, bowel problems and pain with sex. Prolift is a large pore, light-weight, KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 partially absorbable polypropylene mesh that is used to provide a support structure 2 to maintain the organs in their proper anatomic position. FDA cleared the mesh used

3 in Prolift in 2002 and the Prolift kit in May 2008. At the time of Mrs. Carter’s 4 implant in 2010, Prolift was the state of the art and within the standard of care to 5 treat prolapse. Indeed, there was no safer mesh design for the treatment of prolapse 6 at the time of implant. 7 8 b. TVT 9 TVT is a mid-urethral mesh device used to surgically manage a condition 10 called stress urinary incontinence (“SUI”). SUI is when urine leaks out with sudden 11 pressure on the bladder and urethra, causing the urethral sphincter muscles to open. 12 13 The pressure leading to the leakage may be caused by laughing, sneezing, coughing, 14 exercise, walking, and other activities. The TVT device is intended to lift the urethra 15 to its proper anatomic place. It is made from a large pore, light-weight polypropylene 16 mesh. The procedure to implant TVT takes less than 30 minutes and can be done on 17 an out-patient basis if done alone, without other procedures. 18 FDA cleared TVT for use in 1998. This device is the most-studied anti- 19 20 incontinence devices in the world. Professional organizations comprised of pelvic 21 surgeons continue to find that mid-urethral slings, such as TVT, are safe and 22 effective products when used as directed. At the time of Mrs. Carter’s implant, TVT 23 was the state of the art and standard of care to surgically manage SUI. Indeed, there KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 was no safer mesh design at the time of implant, and TVT continues to be available 2 for use by pelvic surgeons.

3 2. Mrs. Carter’s Medical History 4 Mrs. Carter presented to Dr. Geoffrey Hsieh, a board certified 5 6 urogynocologist, in 2010 with recurrent stress and urge urinary incontinence, 7 recurrent vaginal prolapse and vaginal wall mesh exposure from a prior surgery. She 8 had a feeling of a vaginal mass and pressure and was concerned about the vaginal 9 mesh exposure. 10 This was not Mrs. Carter’s first time to seek surgical options for SUI and 11 prolapse. Mrs. Carter’s incontinence dates back to about the mid-1990s. Early 12 13 records note that she had ongoing incontinence for about 8 years prior to 2002 with 14 complaints of leakage with running, coughing or any type of exercise, complaints of 15 urgency and waking up 4-5 times at night to void. She had tried Ditropan XL for 16 her urgency. She also had a Grade 2 cystocele (bladder pushing down into vagina), 17 which she felt caused her lower back pain. 18 Nine years before her consultation with Dr. Hsieh, on January 2, 2001, Mrs. 19 20 Carter had a vaginal sling procedure where two bone anchors were permanently 21 affixed into her pubic bone and a sling made from Repliform was implanted for SUI 22 management. She also had a procedure using sutures to repair her cystocele. Her 23 admission records show that she was on multiple medications including Methadone KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 130 mg bid, Tegretol, Neurontin and Celexa and was attending a methadone clinic 2 daily (treatment for drug addiction). The January 2001 surgery was not successful.

3 Mrs. Carter complained of chronic pelvic pain, pain with sex and recurrent SUI. 4 Three months later, in April 2002, Mrs. Carter had a second surgery. She had 5 a take down of the sling and another procedure permanently affixing two more bone 6 anchors and implanting another Repliform sling. In addition, Prolene sutures were 7 8 inserted to allow future “change and re-fit size of the sling.” Five days after surgery, 9 Mrs. Carter presented to the ER with wound separation, bleeding, and pain. Mrs. 10 Carter was noted to be on the DEA list for receiving narcotics from multiple 11 physicians. She had reportedly removed the suprapubic catheter herself earlier in 12 the day due to discomfort. She was given pain medicine. Records indicate that Mrs. 13 Carter was argumentative with the staff. She was counseled against smoking due 14 15 to her wound complication. She left the hospital prior to final discharge instructions. 16 That April 2002 anti-incontinence procedure was unsuccessful. Mrs. Carter 17 continued to suffer chronic pelvic pain, pain with sex, and recurrent SUI. In June 18 2002, Mrs. Carter presented to Dr. Victor Grigoriev, a board certified urologist, for 19 UTI. She complained of severe pain when urinating and stabbing pain in the urethra. 20 His initial impression was a full take down of the sling and the Prolene sutures. He 21 22 also found that she had a rectocele (rectum pushing into vagina). 23 KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 Mrs. Carter’s rectocele is related to her three pregnancies, chronic cough from 2 nicotine abuse, and long-term opioid abuse. Mrs. Carters’ chronic opioid usage

3 caused bowel dysfunction, which led to prolonged pressure on posterior vagina and 4 a rectocele, which worsened over time. 5 In October 2002, Mrs. Carter sought a consultation from Dr. Shlomo Raz at 6 UCLA. She reported incontinence at rest, when she stood and with coughing and 7 8 sneezing that was treated with pads. She also complained of dyspareunia and rectal 9 pain. She had chronic back pain that was significantly worse after the surgeries as 10 well as subjective numbness and paresthesia in both legs and weakness when 11 attempting to stand. Dr. Raz documented that Mrs. Carter “had chronic pain with 12 persistent incontinence due to a foreign body reaction to bone anchors and Repliform 13 sling.” 14 15 On January 24, 2003, Dr. Raz removed the old sling and the Prolene sutures, 16 but was “unable to remove the bone anchor through the bone itself.” He then created 17 his own sling with a soft Prolene mesh and used it to lift the urethra to its proper 18 anatomic position. Pathology from the January 24, 2003 sling removal showed 19 chronic inflammation and dense fibrosis. 20 One month later, Mrs. Carter returned to Dr. Grigoriev with complaints of 21 22 vaginal pain and dysuria. It was noted that she had been seen earlier, had an erosion 23 KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 that would have required treatment, but she appeared “to be more concerned about 2 legal matters, rather than trying to get better.”

3 Dr. Grigoriev continued to provide treatment to Mrs. Carter. In May 2003, he 4 recommended a removal of the sling. In August 2005, Dr. Grigoriev found that Mrs. 5 Carter had a recurrent bladder prolapse and continued to have a rectocele. She was 6 noted to be agitated, nervous, and noncompliant in the past. 7 8 Also in 2005, Mrs. Carter had numerous visits to various doctors and ERs 9 with continued narcotic-seeking behavior, cocaine use, and psychiatric issues. Her 10 earliest medical records from 2000 show she received Soma, Lortab, Vicodin on the 11 27th and 29th from 2 other providers, which plaintiff “does not admit to,” and she 12 became “irate” when she was not prescribed another pain medication like Lortab. 13 She gave herself self-inflicted wounds to access more pain medications in 2000. She 14 15 presented to a doctor in 2005 at an “altered level of consciousness … suspected 16 narcotics.” 17 By the time Mrs. Carter first saw Dr. Hsieh in 2010, Mrs. Carter had long 18 history of chronic pelvic pain, pain with sex, recurrent SUI, urge incontinence, 19 prolapse, and three failed sling procedures with different types of mesh products. 20 She had stopped having sexual intercourse in 2007. 21 22 In addition, Mrs. Carter’s surgical history included: 3 Cesarean sections; a 23 total abdominal hysterectomy; an abdominoplasty (a tummy tuck); surgery for right KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 hip fracture with hardware (July 12, 2006); surgery for left subtrochanteric femur 2 fracture with hardware (December 21, 2006); surgical removal of hardware in right

3 hip (January 14, 2008); surgical removal of intramedullary hip screw (August 5, 4 2009); left total hip arthroplasty (January 14, 2010); multiple nose surgeries from 5 chronic cocaine abuse. 6 Mrs. Carter’s medical history was significant for chronic bilateral hip pain 7 8 with opioid-dependency, chronic neck and back pain, chronic COPD, smoker’s 9 cough, vaginal pain, dyspareunia, dysuria, UTIs, adhesions, recurrent cystocele, 10 rectocele, SUI, urge incontinence, irritable bowel syndrome, bowel dysfunction, 11 hypothyroidism, ADHD, narcotic abuse, drug seeking behavior, long-standing 12 history of cocaine abuse, septal deviation secondary to cocaine abuse, Wegener’s 13 granulomatosis, and tobacco addiction (half pack to one pack per day for over 30 14 15 years). 16 In addition to her surgical and medical history, Mrs. Carter’s preexisting 17 psychological history is extensive and includes depression, anxiety disorder, bipolar 18 disorder which she has suffered from since childhood and at least 15 suicide 19 attempts, including stabbing her own throat, overdosing on prescription medications, 20 jumping out of a moving car. The worst attempt was when she took 90 Somas, 21 22 which resulted in her being in a coma for three weeks. 23 KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 Mrs. Carter complained that her husband abused her and attempted to “poison 2 her.” When referred to a women’s shelter for possible domestic violence, she

3 refused to go. The next day, she went to the urgent care facility with a red swollen 4 area in her right arm. She told the healthcare providers she was in an abusive 5 relationship but was not ready yet to press any charges or call the police. She 6 reported to her healthcare providers that she went to jail for hitting her 23 year old 7 8 son, but later told her psychiatrist that she called the cops and asked to be locked up. 9 3. Consenting Process and 2010 Surgery 10 Dr. Hsieh never had the benefit of Mrs. Carter’s complete medical history 11 during his treatment and care of the patient. Based on the information provided by 12 Mrs. Carter, diagnostic testing, and his examinations finding a symptomatic 13 rectocele, recurrent SUI and mesh erosion, Dr. Hsieh recommended surgery. On 14 15 July 23, 2010, Dr. Hsieh performed a urethrolysis (removal of scar tissue by the 16 uretha), placement of retropubic mid-urethral sling, excision of the expose sling 17 implanted by Dr. Raz, and placement of a posterior Prolift. 18 Dr. Hsieh testified that, by the time he performed his surgery in 2010, he was 19 very knowledgeable and experienced, had placed over 1,000 slings and half as many 20 prolapse kits. He had received additional training on mesh kits and slings like Prolift 21 22 and TVT. He served as an Ethicon preceptor for about seven years and had 23 participated in studies involving mesh. Dr. Hsieh testified that he knew that risks KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 of mesh included, among other things: acute and chronic pain; dyspareunia; erosion; 2 mesh can change once in the body; shrinkage; infection; inflammation; difficulty of

3 removal; foreign body reaction; urinary problems; and the potential need for 4 revision; and he informed patients like Mrs. Carter of these risks. Dr. Hsieh also 5 understood the risks of non-mesh surgical treatment options for her conditions, like 6 chronic pain, vaginal scarring, infection, urinary problems, organ and nerve damage, 7 8 wound complications, inflammation, fistulas, neuromuscular problems, recurrence, 9 foreign body response to suture, exposure/extrusion of sutures – and these are also 10 the risks for mesh that were well known by 2010, along with contraction. Dr. Hsieh 11 testified that the IFU was adequate for him. Further, Dr. Hsieh’s consent forms were 12 extensive and covered the risks of injuries Mrs. Carter claims in this lawsuit. 13 Dr. Hsieh testified at his deposition that he may have done a different course 14 15 of treatment with complete information (prior surgeries, drug abuse), but based on 16 the information provided by Mrs. Carter, he stands by his decision to treat her 17 rectocele with Prolift Posterior and her SUI with TVT. Moreover, all of the experts 18 in this case – for plaintiff and defense – admit that it was within the standard of care 19 to treat a patient with Prolift and TVT in 2010. 20 4. Prolift & TVT Are Not Defective Under Nevada Law 21 22 Contrary to Plaintiffs’ assertion, Prolift and TVT are not defective. There is 23 no objective evidence supporting a failure to warn or a design defect. As discussed KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 above, Dr. Hsieh knew and understood the risks of surgery with mesh and without. 2 There is no evidence that any other warning would have changed his decision. The

3 only thing that would have changed his decision is had Mrs. Carter disclosed her full 4 medical history. 5 Likewise, while plaintiffs have designated a case specific expert on design 6 defect, Mrs. Carter saw numerous well qualified physicians in urogynecology and 7 8 urology (Dr. Hsieh, Dr. Grigoriev, Dr. Weiss, and Dr. Tenggardjaja) who had used 9 mesh in their practices and who had treated Mrs. Carter for symptoms she believed 10 were related to mesh. None of them testified that the mesh was defective. Further, 11 not one single physician who removed mesh from Mrs. Carter ever saw evidence of 12 degradation, roping, curling, or infection. Rather, Mrs. Carter’s doctors attributed 13 her complaints to other factors, including her chronic pain syndrome, nicotine, 14 15 opioid, and cocaine abuse. 16 For example, Dr. Tenggardjaja testified at his deposition that he cannot rule 17 out cocaine as a contributing cause to Mrs. Carter’s alleged injuries. He explained 18 that “if you use cocaine over a long period of time that can have an effect in terms 19 of healing potential and also in terms of the vascularity in the area[.]” Mrs. Carter 20 was using cocaine during the time she received treatment and care with Dr. 21 22 Tenggardjaja. Her records document longstanding cocaine abuse. During his 23 treatment and care of Mrs. Carter, Dr. Tenggardjaja never formed a medical opinion KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 to a reasonable degree of medical certainty that mesh was a cause of Mrs. Carter’s 2 vaginal pain, pain with sex, vaginal ridging or fistula formation.

3 Furthermore, Mrs. Carter is a poor historian and frequently provides her 4 doctors with inconsistent information. By way of one illustration, among many, Dr. 5 Avi Weiss documents in his records that Mrs. Carter denied vaginal surgery prior to 6 Dr. Raz’s intervention. Mrs. Carter in fact had two prior vaginal surgeries before 7 8 Dr. Raz, which she later admitted to Dr. Weiss. She denied to Dr. Weiss any further 9 surgery after Dr. Hsieh implanted the sling. Later, she admitted that “she ‘forgot’ to 10 report that [D]r. [H]sieh had removed the sling previously.” 11 Medical records report Mrs. Carter mixing psychiatric medicine with cocaine 12 in November 2015. Had the implanting physician known about her history with 13 drugs, it would have made him rethink his treatment plan. 14 15 5. Loss of Consortium Claim 16 Mr. Carter’s consortium claim lacks merit. Mr. and Mrs. Carter have had a 17 challenging relationship, in part because of Mrs. Carter’s bipolar disorder and her 18 report of domestic abuse. Mrs. Carter stopped having sexual intercourse with her 19 20 husband in 2007, three years before she had surgery with Dr. Hsieh. Her records 21 document that sexual intercourse was unbearable because of her hip pain. Also, 22 Mrs. Carter did have an extramarital affair in 2011, which means that she could be 23 KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 intimate, but chose not to be with her husband, which makes sense given her reports 2 of domestic abuse.

3 6. Punitive Damages 4 Plaintiffs have insufficient evidence to support a request for punitive damages. 5 6 Indeed, the MDL Court never found punitive damages warranted in the bellwether 7 trials. 8 Plaintiffs assert in their section above that their punitive damages evidence 9 consists of alleged lack of testing, placing profits over safety, and other reptilian 10 characterizations of company conduct. FDA regulations, however, do not require 11 absolute safety. FDA regulations do not require pre-market testing of Class 2 12 13 medical devices, like Prolift and TVT. 14 If the Court finds that Plaintiffs have met their substantial burden, then 15 Defendants should be able to introduce FDA evidence to rebut a punitive damages 16 claim. See Hrymoc v. Ethicon, Inc., 467 N.J. Super. 42 (App. Div. 2021), cert. 17 granted, No. 085547 (Oct. 22, 2021). Although not binding on this Court, Hrymoc 18 is instructive. Id. (reversing the lower court’s categorical exclusion of 510(k) 19 20 evidence because a “complete ban on any disclosure of the 510(k)-clearance process 21 to the jurors . . . ha[s] the clear capacity to lead to possibly unjust results” and, 22 accordingly, reversing two trial courts’ categorical exclusion of 510(k) evidence). 23 KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 In fact, numerous courts have held that compliance with federal regulations— 2 or even a good-faith attempt at compliance—is incompatible with “actual malice”

3 or “wanton disregard.” E.g., Clark v. Chrysler Corp., 436 F.3d 594, 603 (6th Cir. 4 2006) (finding compliance with National Highway Traffic Safety Administration 5 regulations militated against a finding of malice or reckless disregard sufficient to 6 support punitive damages). Thus, even if the jury ultimately disagrees with Ethicon 7 8 and the FDA about the safety and risks of Prolift and TVT, FDA evidence is at least 9 relevant to show Ethicon’s good faith in designing the devices and writing their 10 respective warnings. See Hrymoc, 467 N.J. Super. at 50 (a defendant “may introduce 11 proof of its compliance with federal regulations to demonstrate that it has satisfied 12 its standard of care”). Regardless of precisely what extent the 510(k) process speaks 13 to safety—though, as explained, it speaks squarely to safety here—Ethicon’s 14 15 compliance with that regulatory process shows conscientiousness and good faith. 16 II. STATEMENT OF JURISDICTION 17 The Court has subject matter jurisdiction under 28 U.S.C. §1132(a) 18 because Plaintiffs are Nevada citizens, Defendants Johnson & Johnson and Ethicon, 19 Inc. are New Jersey citizens, and the amount of in controversy exceeds $75,000, 20 exclusive of interest and costs. Venue is proper under 28 U.S.C. § 1391(b)(2) 21 22 because a substantial part of the events giving rise to these claims occurred in 23 Nevada. KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 III. ADMITTED FACTS THAT REQUIRE NO PROOF 2 1. On July 23, 2010, Tamara Carter had surgery with Dr. Gregory

3 Hsieh, where he implanted a Prolift device to treat her posterior prolapse (rectocele) 4 and a TVT device to treat her SUI. 5 2. Prolift is a prescription medical device intended to treat pelvic 6 prolapse in women. 7 8 3. TVT is a prescription medical device intended to treat stress 9 urinary incontinence in women. 10 IV. UNADMITTED FACTS THAT WILL NOT BE CONTESTED AT 11 TRIAL 12 None. 13 V. ISSUES OF FACT TO BE TRIED AND DETERMINED AT 14 TRIAL ON THE MERITS 15 1. Have Plaintiffs proven by a preponderance of the evidence that 16 the warnings for Prolift and/or TVT were inadequate for Dr. Hseih, the implanting 17 surgeon? 18 19 2. Have Plaintiffs proven by a preponderance of the evidence that 20 the inadequacies in the warnings caused Mrs. Carter injury? 21 a. If so, the nature, extent, and amount of Plaintiffs’ damages. 22 3. Have Plaintiffs proven by a preponderance of the evidence that 23 Prolift and/or TVT were unreasonably dangerous and defectively designed? KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 4. Have Plaintiffs proven by a preponderance of the evidence that 2 the alleged defects in Prolift and/or TVT caused Mrs. Carter injury?

3 a. If so, the nature, extent, and amount of Plaintiffs’ damages. 4 5. If liability is established based on any of the grounds stated 5 above, have Plaintiffs proven by clear and convincing evidence that Defendants’ 6 conduct was malicious, oppressive, willful, wanton, reckless, or grossly negligent? 7 8 a. If so, the amount of punitive damages. 9 6. Have Defendants proven by the preponderance of the evidence 10 that Tamara Carter assumed the risk of the injuries that she suffered? 11 Additionally, Defendants believe, and Plaintiffs disagree, that the 12 following are issues of fact to be tried and determined at trial: 13 14 1. Were Tamara Carter’s injuries, in whole or in part, caused by 15 something other than Prolift or TVT? 16 2. Did Tamara Carter contribute to her alleged injuries? 17 18 VI. ISSUES OF LAW TO BE TRIED AND DETERMINED AT TRIAL 19 1. Was Prolift unreasonably dangerous and defective in its design, 20 and if so, was this a proximate cause of Tamara Carter’s injuries? 21 22 2. Was TVT unreasonably dangerous and defective in its design, 23 and if so, was this a proximate cause of Tamara Carter’s injuries? KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 3. Was Prolift unreasonably dangerous and defective because of its 2 warnings, and if so, was this a proximate cause of Tamara Carter’s injuries?

3 4. Was TVT unreasonably dangerous and defective because of its 4 warnings, and if so, was this a proximate cause of Tamara Carter’s injuries? 5 5. Did Tamara Carter assume the risk of the injuries that she 6 suffered? 7 8 6. Have Plaintiffs proved by clear and convincing evidence that 9 Defendants’ conduct was malicious, oppressive, willful, wanton, reckless, or grossly 10 negligent under New Jersey law? 11 7. Is FDA evidence admissible at trial? 12 8. The parties intend to file motions in limine in accordance with 13 LR 16.3. 14 15 Additionally, Defendants believe, and Plaintiffs disagree, that the 16 following are issues of law to be tried and determined at trial: 17 1. Were Tamara Carter’s alleged injuries proximately caused, in 18 whole, or in part, by something other than Prolift or TVT? 19 2. Did TVT conform to the state-of-the-art at the time of Mrs. 20 Carter’s implant on July 23, 2010? 21 22 3. Did Prolift conform to the state-of-the-art at the time of Mrs. 23 Carter’s implant on July 23, 2010? KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 4. Did Tamara Carter knowingly and voluntarily assume all risks 2 associated with TVT and/or Prolift, and thus the “last clear chance” and assumption

3 of the risk doctrines bar in whole or in part the damages that Plaintiffs seek to 4 recover? 5 5. Is FDA evidence admissible to refute Plaintiffs request for 6 punitive damages? 7 8 6. Should Plaintiffs be precluded from presenting evidence that 9 Defendants cannot refute without reference to the FDA? 10 7. Does the imposition of punitive or exemplary damages violate 11 Ethicon’s constitutional rights, including but not limited to those under the due 12 process clauses in the Fifth and Fourteenth Amendments to the Constitution of the 13 United States, and the equivalent or correlative applicable provisions in the Nevada 14 15 Constitution, common law, public policy, applicable statutes and court rules of the 16 applicable states to these amendments and the excessive fines clause in the Eighth 17 Amendment to the Constitution of the United States and the double jeopardy clause 18 in the Fifth Amendment to the Constitution of the United States. 19 8. With respect to Plaintiffs’ demand for punitive damages, 20 Defendants specifically incorporate by reference all standards of limitations 21 22 regarding the determination and enforceability of punitive damage awards that arise 23 under BMW of North America, Inc. v. Gore, 517 U.S. 559 (1996); Cooper Industries, KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 Inc. v. Leatherman Tool Group, Inc., 532 U.S. 424 (2001); State Farm Mut. Auto 2 Ins. Co. v. Campbell, 538 U.S. 408 (2003); Philip Morris USA v. Williams, 549 U.S.

3 346 (2007), and their progeny, as applied by the federal courts of appeals, together 4 with all such standards applicable under any other state’s law. 5 VII. DEPOSITIONS & EXHIBITS 6 a) The parties agree to use company witness deposition 7 8 designations from Terressa Williams, et al. v. Ethicon, et al., Civil Action No. 5:20- 9 cv-00234-MTT (M.D. Ga) (Judge Marc T. Treadwell) for Prolift and Carolyn Lewis, 10 et al. v Ethicon, et al, Civil Action No. 2:12-cv-04301 (S.D. W. Va.) (Judge Joseph 11 R. Goodwin) for TVT.3 12 b) Plaintiffs’ case specific deposition designations and objections 13 thereto are attached as Exhibit “A”. 14 15 c) Defendants’ case specific deposition designations and objections 16 thereto are attached as Exhibit “B”. 17 d) Per Court order dated March 24, 2022 (ECF 220), the parties 18 shall provide exhibit lists with objections no later than ten (10) after the Court’s 19 ruling on motions in limine. 20 21 22 3 The parties shall meet and confer on two depositions that occurred after the Lewis trial (Ms. Angelini, Dr. Weisberg), and Dr. Hinoul’s deposition testimony that was 23 not played at the Lewis trial. KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 e) Electronic Evidence: The parties do not intend on presenting 2 electronic evidence for purposes of jury deliberations.

3 VIII. WITNESSES THAT MAY BE CALLED BY THE PARTIES AT 4 TRIAL 5 a) Plaintiffs’ Witnesses: 6 1. Tamara Carter 7 2. David Carter 3. Adam Carter 8 4. David M. Carter 9 5. Eric C. Carter 6. Jason A. Carter 10 7. Saleha Baig, M.D. 8. Martin Binyange, DNP 11 9. Gregory C. Hsieh, M.D. 10. Victor Grigoriev, M.D. 12 11. Christopher Tenggardjaja, M.D. 13 12. Avi C. Weiss, M.D. 13. Laura Angelini 14 14. Axel Arnaud, M.D. 15. Thomas Barbolt 15 16. Peter Cecchini 16 17. Meng Chen, M.D., Ph.D. 18. Scott Ciarrocca 17 19. L. Thomas Divilio, M.D. 20. Katrin Elbert, Ph.D. 18 21. James Hart, M.D. 22. Piet Hinoul, M.D., Ph.D. 19 23. Kimberly Hunsicker 20 24. Richard Isenberg, M.D. 25. Scott Jones 21 26. Gene Kammerer 27. Aaron Kirkemo, M.D. 22 28. Daniel Lamont 23 29. Bryan Lisa 30. Vincent Lucente, M.D. KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 31. James Mittenthal 32. Sean O’Bryan 2 33. Charlotte Owens, M.D. 34. Paul Parisi 3 35. David Robinson, M.D. 4 36. Renee Selman 37. Jessica Shen, M.D. 5 38. Daniel Smith 39. Price St. Hilaire 6 40. Thomas Storozuk 41. Christopher Vailhe, Ph.D. 7 42. Clifford Volpe 8 43. Martin Weisberg, M.D. 44. Mark Yale 9 45. Record Custodians 46. Daniel Elliott, M.D. 10 47. Prof. Dr. Med. Uwe Klinge, M.D. 11 48. Bruce Rosenzweig, M.D. 49. Paul Michaels, M.D. 12 50. R. Brian Raybon, M.D. 51. Dr. Peggy Pence (conditional on admission of 13 FDA/regulatory evidence) 14 Plaintiffs reserve the right to call any witness on Defendants’ witness list. 15 16 b) Defendants’ Witnesses: 17 Fact Witnesses 1. Tamara Carter 18 2. David Carter 3. Adam Carter 19 4. David M. Carter 20 5. Eric C. Carter 6. Jason A. Carter 21 7. Saleha Baig, M.D. 8. Martin Binyange, DNP 22 9. Gregory C. Hsieh, M.D. 23 10. Victor Grigoriev, M.D. 11. Christopher Tenggardjaja, M.D. KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 12. Avi C. Weiss, M.D. 13. Axel Arnaud, M.D. 2 14. Thomas Barbolt 15. Scott Ciarrocca 3 16. Katrin Elbert, Ph.D. 4 17. Piet Hinoul, M.D., Ph.D. 18. Richard Isenberg, M.D. 5 19. Vincent Lucente, M.D. 20. Charlotte Owens, M.D. 6 21. Daniel Smith, Ph.D. 22. Mark Yale 7 23. Record Custodians 8 Expert Witnesses 9 1. Christina Pramudji, M.D. 2. Salil Khandwala, M.D. 10 3. Juan Carlos Felix, M.D. 11 4. Steve MacLean, Ph.D. PE 5. Elizabeth Grill, Ph.D. 12 Defendants reserve the right to call any witness on Plaintiffs’ witness list. 13 IX. DATES ATTORNEYS OR PARTIES OFFER FOR TRIAL 14 15 The attorneys have met and jointly offer these three trial dates: 16  September 12, 2022 to September 23, 2022 17  February 27, 2023 to March 10, 2023 18 19  March 13, 2023 to March 24, 2023 20 It is expressly understood by the undersigned that the Court will set the trial of this 21 matter on one of the agreed dates if possible; if not, the trial will be set at the 22 convenience of the Court’s calendar. 23 KAEMPFER CROWELL 1980 Festival Plaza Dri2ve 4 1 TIME NEEDED 2 The parties estimate that the trial will take a total of 10 days, equally divided among the parties. 5 ‘ APPROVED AS TO FORM AND CONTENT: g || WAGSTAFF & CARTMELL LLP) BUTLER SNOW LLP Diane K. Watkins ? || Thomas P. Cartmell (Pro Hac Vice) Anita Modak-Truran _____ Diane K. Watkins (Pro Hac Vice) Anita Modak-Truran (Pro Hac Vice) 10 || Nate Jones (Pro Hac Vice) Jin Yoshikawa (Pro Hac Vice) 4740 Grand Avenue, Suite 300 150 3rd Avenue South, Suite 1600 11 || Kansas City, MO 64112 Nashville, Tennessee 37201 12 KAEMPFER CROWELL WETHERALL GROUP, LTD. Peter C. Wetherall (NV No. 04414) Robert McCoy, No. 9121 13 |] 9345 W. Sunset Road, Suite 100 Sihomara L. Graves, No. 13239 Las Vegas, NV 89148 1980 Festival Plaza Drive, Suite 650 14 Las Vegas, Nevada 89135 Attorneys for Plaintiffs 15 Attorneys for Defendants Ethicon, Inc. and Johnson & Johnson 16 7 ACTION BY THE COURT 18 This case is set for a jury trial on the fixed/stacked calendar off 19 January 30, 2023 at 9:00 a.m. with Calendar call to be held on January 17, 2023 at 20 9:30 a.m. in courtroom 4A. 21 DATED: 5/23/2022 C ™~ 22 + 23 UNITED STATES DISTRICT JUDGE

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