Opinion ID: 4854742
Heading Depth: 3
Heading Rank: 1

Heading: Plaintiﬀ’s Relevant Medical History

Text: In 1999, Ms. Stark began seeing Andrew Roth, M.D., as her primary care physician and obstetrician-gynecologist. During a December 2006 appointment, Dr. Roth diagnosed Ms. Stark with stress urinary incontinence, which is the unintentional loss of urine as a result of an increase in intra-abdominal pressure, such as that caused by coughing or sneezing. Dr. Roth provided Ms. Stark with information about a possible treatment for her incontinence, the surgical implantation of a mesh TVT-Obturator (“TVT-O”) sling device manufactured by defendant Ethicon, Inc., a subsidiary of defendant Johnson & Johnson. Dr. Roth testiﬁed that, as of his deposition in 2019, he had implanted approximately 400 TVT-O slings. On February 5, 2007, Ms. Stark returned to Dr. Roth for a consultation about the TVT-O sling. Dr. Roth also oﬀered Ms. Stark a non-surgical treatment option, but she opted for surgery because she wanted a more permanent solution with a higher likelihood of success. Dr. Roth described the surgery to Ms. Stark in the following terms: “We would make a small incision in the vagina. I would thread a tape [the TVT-O sling] underneath her bladder. It would wrap around the pubic bone and come out the inner thigh on both sides.” Dr. Roth testiﬁed that they discussed potential risks associated with the procedure, including “death, injury to bowel or bladder, possible nephrostomy, colostomy, exploratory laparotomy, hysterectomy, blood replacement, infection and prolonged catheterization.” They did not speciﬁcally discuss the risk of mesh from the sling eroding into her urethra. Dr. Roth believed that the potential beneﬁts of the TVT-O sling outweighed the risks in Ms. Stark’s case. 4 No. 20-1837 Ten days later, on February 15, Dr. Roth performed surgery to implant the TVT-O sling. After the surgery, Ms. Stark had a general feeling that it had not worked. She continued to experience urinary incontinence, leakage, and subsequent odor.1 After the surgery, Dr. Roth explained to Ms. Stark that her Ehlers-Danlos syndrome (“EDS”) might be contributing to her poor wound healing and post- implantation complications. EDS refers to a group of inherited disorders that aﬀect the body’s connective tissues. Ehlers-Danlos syndrome, Mayo Clinic, https://www.mayoclinic.org/diseases-conditions/ehlersdanlos-syndrome/symptoms-causes/syc-20362125 (last visited Aug. 23, 2021). People with EDS generally experience symptoms such as hyperﬂexible joints and extremely stretchy, fragile skin. Id. Skin fragility can lead to postsurgical issues, including increased bleeding and poor wound healing. Dr. Roth did not tell Ms. Stark that mesh from the sling might be the cause of her pain—that the mesh itself might be defective. For her part, Ms. Stark believed then that her EDS was to blame. In early 2008, Ms. Stark sought a second opinion to address her continued incontinence. On March 5, 2008, Denise Elser, M.D., a urogynecologist, determined that she was still experiencing tenderness in her pelvic ﬂoor muscles, stress incontinence, and cystocele. Cystocele, sometimes referred to as a dropped or fallen bladder, occurs when the bladder drops into the vagina. Cystocele (Fallen Bladder), Cleveland Clinic, 1Dr. Roth testified that urge incontinence can also be a complication of TVT-O sling implantation. No. 20-1837 5 https://my.clevelandclinic.org/health/diseases/15468-cystocele-fallen-bladder (last visited Aug. 23, 2021). Dr. Elser also found that Ms. Stark’s TVT-O sling had shifted. Dr. Elser recommended, and Ms. Stark agreed to, implantation of a mesh TVT retropubic sling, also manufactured by Ethicon, to treat her continued incontinence. Both the TVT-O and TVT retropubic slings are made of synthetic mesh. Midurethral sling surgery for stress incontinence, Harvard Women’s Health Watch (Sep. 2010), https://www.health.harvard.edu/newsletter_article/midurethral-sling-surgery-forstress-incontinence (last visited Aug. 23, 2021). The retropubic method positions the mesh under the urethra in a U shape. The ends of the sling are brought up behind the pubic bone and out through incisions above the pubic bone. The TVT-O approach passes the mesh under the urethra and out through incisions in the groin. As part of the informed consent process, Dr. Elser discussed with Ms. Stark the risks of mesh erosion and the need for additional operations to excise any eroded mesh, as well as recurrent stress incontinence, urge incontinence, and voiding diﬃculty. Dr. Elser scheduled the surgery for May 21, 2008. During the surgery, Dr. Elser discovered ﬁbers of eroded mesh from the TVT-O sling implanted by Dr. Roth that had become embedded in Ms. Stark’s urethral wall. After implanting the new TVT retropubic sling, Dr. Elser removed the eroded mesh and repaired the urethra. However, Dr. Elser was unable to remove all the eroded mesh. Following the surgery, Dr. Elser explained to Ms. Stark that mesh from the previously implanted TVT-O sling had 6 No. 20-1837 eroded into her urethra. Dr. Elser told her that EDS might make her more prone to mesh erosion. At no point did Dr. Elser suggest to Ms. Stark that the mesh from the ﬁrst sling either was or could be defective. Ms. Stark next saw Dr. Elser on February 1, 2010. She complained of pelvic pain and increased incontinence. Following an examination, Dr. Elser explained that there was no evidence of stress incontinence, that Ms. Stark was maintaining good bladder volume, and that it appeared that the new sling had accomplished what it was supposed to do. As far as the pelvic pain, Dr. Elser determined that Ms. Stark’s fractured coccyx and recent knee surgery might be contributing factors. The two also discussed the possibility of recurrent mesh erosion into the urethra. They planned a cystoscopy for the following month. In a cystoscopy, a physician uses a tube with a camera to examine visually the urethra and the lining of the bladder. Cystoscopy, Mayo Clinic, https://www.mayoclinic.org/tests-procedures/cystoscopy/about/pac-20393694 (last visited Aug. 23, 2021). Ms. Stark last saw Dr. Elser on March 11, 2010. She did not see another physician about her incontinence until August 2015. During that ﬁve-and-a-half-year gap, Ms. Stark said that her symptoms worsened: the “incontinence was worse than before I had the ﬁrst [February 2007] surgery, … everything got worse: pain, the ﬂow, the spasms, the leakage, the smell, waking up at night.” On August 19, 2015, Ms. Stark met with Sandra Valaitis, M.D., to discuss her recurrent stress incontinence. While performing a cystoscopy, Dr. Valaitis discovered mesh in Ms. Stark’s urethra. In November 2015, Dr. Valaitis attempted to surgically remove what remained of the TVT-O sling—by this No. 20-1837 7 point, only eroded mesh. However, Dr. Valaitis was unable to remove the remnants of mesh from Ms. Stark’s urethra. While Dr. Valaitis declined to oﬀer an opinion about the exact cause of Ms. Stark’s continued incontinence and postprocedure complications, she testiﬁed that she never said anything to Ms. Stark that would have led her to believe that the mesh—even the eroded mesh—was defective. Also, in her deposition, Dr. Valaitis, like Dr. Roth and Dr. Elser before her, identiﬁed EDS as a possible culprit. Ms. Stark “has a known connective tissue disorder, so her connective tissue is much weaker than the average patient, and so that could certainly have played a role.”