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Plaintiff claimed pelvic mesh devices had design defects
Philadelphia County Court of Common Pleas
other-urethral erosion; other-scar and/or disfigurement; pelvis; abdomen; urological-dyspareunia; urological-incontinence; urological-urinary tract infection; gynecological-vagina; mental/psychological-emotional distress
Fraud - Fraudulent Concealment; Products Liability - Design Defect, Medical Devices, Strict Liability
Ella Cederberg Ebaugh and Marvin Ebaugh v. Ethicon Women's Health and Urology, a division of Ethicon Inc.; Ethicon Inc.; Gynecare; Johnson & Johnson; Secant Medical; Secant Medical Inc.; Secant Medical LLC; and Prodesco Inc., No. 130700866
September 7, 2017
Marvin Ebaugh (Male),
Ella Cederberg Ebaugh (Female, 40s)
Kila B. Baldwin; Kline & Specter, PC; Philadelphia, PA, for Marvin Ebaugh, Ella Cederberg Ebaugh ■ Tracie L. Palmer; Kline & Specter, PC; Philadelphia, PA, for Marvin Ebaugh, Ella Cederberg Ebaugh ■ Elia A. Robertson; Kline & Specter, PC; Philadelphia, PA, for Marvin Ebaugh, Ella Cederberg Ebaugh
Uwe Klinge; M.D.; Materials Science; called by: Kila B. Baldwin, Tracie L. Palmer, Elia A. Robertson ■ Bruce Rosenzweig; M.D.; Urogynecology; Chicago, IL called by: Kila B. Baldwin, Tracie L. Palmer, Elia A. Robertson ■ David Hopkins; A.S.A.; Economics; King of Prussia, PA called by: Kila B. Baldwin, Tracie L. Palmer, Elia A. Robertson ■ Daniel Elliott; M.D.; Urogynecology; Rochester, MN called by: Kila B. Baldwin, Tracie L. Palmer, Elia A. Robertson ■ Michael Margolis; M.D.; Urogynecology; Burlingame, CA called by: Kila B. Baldwin, Tracie L. Palmer, Elia A. Robertson ■ Vladimir Iakovlev; M.D.; Pathology; Toronto, CA called by: Kila B. Baldwin, Tracie L. Palmer, Elia A. Robertson
Johnson & Johnson,
Secant Medical LLC,
Secant Medical Inc.,
Ethicon Women's Health and Urology
None reported; for Prodesco Inc., Secant Medical, Secant Medical LLC, Secant Medical Inc. ■ Kat Gallagher; Beck Redden LLP; Houston, TX, for Gynecare, Ethicon Inc., Johnson & Johnson, Ethicon Women's Health and Urology ■ W. Curt Webb; Beck Redden LLP; Houston, TX, for Gynecare, Ethicon Inc., Johnson & Johnson, Ethicon Women's Health and Urology
Marc Toglia; Urogynecology; Media, PA called by: Kat Gallagher, W. Curt Webb ■ Otto Vogel; Neuropathology; Palo Alto, CA called by: Kat Gallagher, W. Curt Webb ■ Teri Longacre; Pathology; Stanford, CA called by: Kat Gallagher, W. Curt Webb ■ Jaime Sepulveda; OB-GYN; South Miami, FL called by: Kat Gallagher, W. Curt Webb ■ Janet Tomezsko; Urogynecology; Skokie, IL called by: Kat Gallagher, W. Curt Webb ■ Daniel Sexton; Infectious Diseases; Durham, NC called by: Kat Gallagher, W. Curt Webb ■ Elaine Duncan; Materials Science; Stillwater, MN called by: Kat Gallagher, W. Curt Webb ■ Steven MacLean; Materials Science; Boston, MA called by: Kat Gallagher, W. Curt Webb ■ Timothy Ulatowski; FDA Regulatory Affairs; Washington, DC called by: Kat Gallagher, W. Curt Webb
In 2005, plaintiff Ella Cederberg Ebaugh, a clerical worker in her 40s, was diagnosed with mixed-urinary incontinence, including stress urinary incontinence-involuntary leakage of urine when she exercised. Following the diagnoses, Ebaugh unsuccessfully tried to treat her condition with physical therapy and medication. In May 2007, she had surgery to have implanted a TVT-Secur pelvic-mesh device. The device is a tension-free vaginal tape (TVT) made of polypropylene, and is implanted through the vagina in the tissue below the mid-urethra. In July, after the TVT-Secur provided no relief, a TVT sling was implanted. The devices eroded through her urethra on three separate occasions, and required mesh removal surgeries in June 2011, March 2012, and March 2016. Ebaugh also had an erosion of mesh into her bladder; the mesh was removed in the March 2012 surgery. The TVT-Secur was marketed in the United States in 2006, and removed from the market in 2012. The TVT sling was first marketed in the United States in 1999, and remains on the market. Ebaugh alleged that she suffered permanent pelvic injuries from these devices. Ebaugh sued mesh-manufacturer Ethicon and parent company Johnson & Johnson, alleging design defect under theories of strict liability and negligence. Ebaugh also sued Secant Medical Inc. and Prodesco Inc., which manufactured some of the pelvic-mesh material. Both companies were dismissed, prior to trial. Ebaugh's counsel played deposition testimonies of Ethicon officials, including its medical directors and the president of Ethicon Women's Health. According to Ebaugh's counsel, the companies knew of the serious risks presented to women by these products when they were developed, but continued to go forward in releasing them without appropriate studies and/or design changes. Ebaugh's expert in urogynecology (Bruce Rosenzweig) testified that Ethicon marketed and sold the TVT sling and TVT-Secur despite their numerous defects, including chronic foreign-body reaction; loss of pore-size with tension; fibrotic bridging leading to scar-plate formation and mesh encapsulation; shrinkage of the encapsulated mesh; risk of erosion; and failure of mesh to stay in place upon implant. The expert faulted Ethicon for failing to inform physicians and their patients about numerous risks associated with these products, despite the fact that the risks were known before the products were placed on the market. Ethicon and Johnson & Johnson maintained that the development of the devices was led by doctors, supported by medical research, and the risks of using pelvic mesh were well known throughout the medical community. The companies contended that, despite the later complications, the mesh worked properly for several years to treat Ebaugh's stress urinary incontinence. The companies' expert in obstetrics-gynecology testified that the rate of complications with the TVT sling and TVT-Secur were low and acceptable.
Ebaugh has intrinsic sphincter deficiency, meaning that she has almost no control of the muscles surrounding the urethra. This causes her to lose the entire contents of her bladder with almost no warning. She further suffers partial bladder obstruction, recurrent urinary tract infections, massive scarring of the mid- and distal urethra, dyspareunia (pain during sex), and chronic pain in her pelvis and abdomen. Ebaugh's other expert in urogynecology testified that, because there is no way to safely remove the mesh, Ebaugh is at risk for continued complications for the rest of her life. Ebaugh testified that she is in constant pain and always has to be near a bathroom. She has constant urgency which requires her to hurry to a bathroom out of fear of urinating on herself. If she goes out, she uses adult diapers and wipes. She sleeps on two towels and has a commode beside her bed. Ebaugh stated that she has monthly urinary tract infections in which the pain is akin to childbirth, and it is immensely painful to have sex, which she and her husband have once every few months. She sought damages for past and future pain and suffering. Ebaugh's husband, who had withdrawn his claim for loss of consortium, prior to trial, testified about the difficulties of her condition and the impact it had on their life. He stated that her condition had made Ebaugh a shell of her former self. In seeking punitive damages, Ebaugh's counsel maintained that Ethicon and Johnson & Johnson's conduct was in wanton and willful disregard of her well-being. The companies had a combined net worth of approximately $73 billion. Ethicon and Johnson & Johnson's expert in urogynecology testified that Ebaugh's pain was from a prior hip implant, and her urinary problems were due to atrophy.
The jury found that Ethicon and Johnson & Johnson negligently designed the TVT sling and TVT-Secur, and that the designs were defective, for which strict liability applied. According to the jury, Ebaugh was harmed by acts or omissions of Ethicon and Johnson & Johnson, and the companies' conduct was in wanton and willful disregard of her well-being. Ebaugh was determined to receive $57.1 million.
Ella Cederberg Ebaugh: $50,000,000 Personal Injury: Punitive Exemplary Damages; $7,100,000 Personal Injury: compensatory damages
Michael E. Erdos
6 male/ 6 female
This report is based on information that was provided by plaintiffs' counsel. Defense counsel did not respond to the reporter's phone calls. Prodesco Inc., Secant Medical, Secant Medical Inc., and Secant Medical LLC were not asked to contribute.