For the third time in as many years, a Pennsylvania jury has awarded significant damages to a patient who suffered permanent injury after having been surgically implanted with a pelvic mesh device manufactured by Johnson & Johnson subsidiary Ethicon, Inc.—this time in a $20-million verdict handed up in the Philadelphia Court of Common Pleas. In December 2015 and February 2016, two other women received $12.5-million and $13.5-million verdicts in similar bellwether suits against Ethicon (see Products Liability Law Daily’s December 23, 2015 analysis and February 10, 2016 analysis, respectively). In the latest case, the jury found that the transvaginal tape originally implanted into a New Jersey woman was defectively designed, the manufacturers failed to adequately warn of the device’s medical risks, and both the design defect and failure to warn were the cause of her injuries (In re Pelvic Mesh Litigation (Engleman v. Ethicon, Inc.), April 28, 2017).
Underlying allegations. In 2007, a then 46-year-old woman suffering from stress urinary incontinence (SUI) was surgically implanted with Ethicon’s TVT-Secur transvaginal mesh in order to help prevent urine leakage. Only two months after the initial surgery, the patient’s gynecologist found and surgically treated two erosions of the mesh, but she continued to experience SUI, residual vaginal pain, and irritation. Shortly thereafter, the patient underwent a second surgical revision by a different gynecologist who mistakenly believed at the time that he had removed all of the eroded TVT-Secur.
Nevertheless, several years later, the woman began to experience stabbing pain in her bladder area and had to undergo a third revision surgery to remove yet more mesh found to have eroded into her vagina. Despite all of those efforts, additional portions of the TVT-Secur remained in the patient, who was left with chronic pelvic pain, urinary dysfunction, and scarring, and for whom physical therapy, biofeedback, medication, and/or further surgery are not expected to completely resolve her problems.
The woman filed suit against Ethicon and its parent company, Johnson & Johnson, alleging that all of her injuries were directly related to the defective TVT-Secur and could have been prevented if the companies had acted responsibly in the design, manufacture, and marketing of the surgical device. In her pre-trial memorandum, the patient asserted that TVT-Secur never should have been sold, especially without first having clinical data demonstrating its safety and efficacy.
Citing testimony from the companies’ own employees, she also contended that the device was defective because its “pores” were too small and allowed the mesh to become filled with scar tissue, making the mesh stiff/rigid and forming a “scar plate” in the sensitive vaginal tissue. Furthermore, the mesh deforms under stress, causing a greater inflammatory response, foreign body reaction, scarring, and associated life-altering complications. Johnson & Johnson knew of those risks at the time that TVT-Secur was launched in the United States but, despite that awareness, did not provide adequate labeling for the device, she maintained.
Jury’s findings. After trial, the jury found that the TVT-Secur device was defective in design and that the defect was the cause of the patient’s injuries. In addition, the jury found that the manufacturers failed to warn of the TVT-Secur’s risks and that this failure also was a cause of the patient’s injuries. As such, the jury awarded $2.5 million in compensatory damages and another $17.5 million in punitive damages.
The case is No. 05384.
Attorneys: Ben Anderson (Anderson Law Offices), Dan Thornburgh (Aylstock Witkin) and Chris Gomez (Kline & Specter) for Peggy Engleman. James Campbell (Campbell & Campbell), Rita Maimbourg (Tucker Ellis) and Burt Snell (Butler Snow) for Johnson & Johnson and Ethicon, Inc.
Companies: Johnson & Johnson; Ethicon, Inc.
MainStory: TopStory JuryVerdictsNewsStory DesignManufacturingNews DamagesNews WarningsNews MedicalDevicesNews PennsylvaniaNews
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