Case details

Defective design of pelvic mesh caused pain, patient claimed

SUMMARY

$5700000

Amount

Verdict-Plaintiff

Result type

Not present

Ruling
KEYWORDS
chronic pain syndrome, dyspareunia, urological
FACTS
In March 2011, plaintiff Coleen Perry, 50, underwent implant surgery to treat stress-induced incontinence. The surgery involved the implantation of a device called a TVT-Abbrevo pelvic mesh, which was designed and manufactured by Ethicon Inc., a wholly owned subsidiary of Johnson & Johnson. At the same time, Perry underwent an anterior colporrhaphy to treat her bulging bladder, a posterior colporrhaphy to treat bulging rectum, and a perineoplasty. Following the surgery, Perry’s incontinence was cured but she experienced an erosion of the mesh into her vagina, causing her chronic pain. As a result, she underwent surgery to have the pelvic mesh removed nine months later, but the surgeon was unable to remove all of the mesh. Perry sued Ethicon Inc.; Johnson & Johnson; and the implanting surgeon, Dr. Hung Luu. Perry alleged that Ethicon and Johnson & Johnson defectively designed the medical device and were negligent for failing to instruct surgeons how to remove the device when complications developed. Perry also alleged Ethicon and Johnson & Johnson negligently misrepresented material facts about the safety of the TVT-Abbrevo device to doctors. Luu was ultimately dismissed from the case without prejudice and without the necessity of filing an answer. Plaintiff’s counsel contended that the plastic material used in the TVT Abbrevo device was too heavy and that the pores were too small to allow healthy tissue integration. Counsel argued that in marketing its device, Ethicon and Johnson & Johnson taught surgeons how to install the mesh, but did not teach surgeons how to remove it. Counsel also asserted a failure to warn claim, arguing that Ethicon and Johnson & Johnson failed to tell doctors that if the mesh did not perform as planned, or caused constant pain, it could prove impossible to remove from the human body. Thus, plaintiff’s counsel contended that doctors could not give patients, such as Perry, enough information for them to give a proper informed consent to the implant procedure. Counsel for Ethicon and Johnson & Johnson contended that the TVT Abbrevo sling represented the “gold standard” of care, and presented expert witnesses who opined that, in the treatment of stress urinary incontinence, the TVT Abbrevo sling was superior to the old Burch method of suturing. Counsel also contended that the device’s Prolene material was the same material as the Prolene sutures used for decades in a variety of surgical applications, so the body’s inflammatory response wasn’t any different for mesh than it was for sutures. Thus, defense counsel argued that changes in Perry’s diet prevented her from healing properly and led to pelvic pain that Perry mistakenly attributed to the plastic mesh that remained inside her. Counsel also argued that Perry’s other pelvic floor surgeries might have been factors in causing her pain, apart from the mesh., Prior to the implant surgery, Perry suffered from stress-urinary incontinence, which involves unwanted urine leakage with coughing, sneezing, laughter or other exertion. She also had urge incontinence and stress urinary incontinence. Following the implant surgery, Perry complained of chronic pain, especially during sexual intercourse. As a result, she elected to have the TVT Abbrevo device removed six months after the implant surgery. An explant surgeon removed as much of the mesh as he was able, but portions of it remain inside her. Perry claimed that she now suffers continued and worsening incontinence, in addition to permanent, debilitating pain and dyspareunia (pain with sex). Perry’s husband initially sought recovery for his loss of consortium, but the claim was withdrawn and not considered by the jury. Counsel for Ethicon and Johnson & Johnson attributed Perry’s post-surgery pain and erosion to the perineoplasty and/or posterior colporrhaphy procedures.
COURT
Superior Court of Kern County, Bakersfield, CA

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