By Pamela C. Maloney, J.D.
A Georgia federal jury awarded $4,400,000 to a woman who developed serious injuries after the implantation of a pelvic mesh device—a transobturator vaginal sling—that had been manufactured by Mentor Corp., a division of Johnson & Johnson. The verdict included $4 million in punitive damages. The jury determined that Mentor Corp.’s device had been defectively designed and manufactured, and that the company had failed to provide the patient’s physician with adequate warnings regarding the risks associated with the device (In re: Mentor Corp. ObTape Transobturator Sling Products Liability Litigation (Taylor v. Mentor Corp.), February 18, 2016).
The patient had been implanted with a transobturator vaginal sling product known as “ObTape,” designed, manufactured, packaged, labeled, and sold by Mentor, to treat stress urinary incontinence. After the implantation surgery, the patient alleged that she suffered serious and permanent bodily injuries, including erosion of the ObTape, chronic infections, pain, exacerbation of her urinary incontinence, and the need for multiple additional surgical procedures and medical treatment as well as the need for extensive future medical care. She filed a lawsuit against Mentor, setting forth counts for strict liability and negligence claims based on design and manufacturing defects and failure to provide appropriate and necessary warnings.
General allegations. According to the patient’s complaint, Mentor’s ObTape brand transobturator vaginal sling had undergone inadequate pre-market testing to determine its safety and efficacy prior to implantation in humans, and that the testing had been limited to animal testing. Despite the limited animal testing conducted by Mentor prior to its first marketing of the ObTape brand transobturator vaginal sling in 2003, the results had demonstrated that the device caused adverse tissue reactions in the rabbits. However, the complaint averred, Mentor performed no additional safety or efficacy testing in human vaginal tissues to confirm that the medical device was safe and effective for use in women. The complaint further alleged that Mentor knowingly and deliberately made material misrepresentations to the Food & Drug Administration concerning the safety, efficacy, design and manufacture of its transobturator vaginal sling device.
Specific allegations. In setting forth the basis of her strict liability and negligent design and manufacturing defect claims, the patient alleged that Mentor’s use of inappropriate material (i.e., non-woven, microporous, inelastic polypropylene mesh) and inadequate pore size (less than the minimum pore size of 50 microns or greater) in its transobturator vaginal sling device created a propensity for that device to cause infections and/or the formation of abscesses when placed in the vaginal area, which, in turn, resulted in an unreasonably high rate of infections, abscesses, erosion, perforation, and extrusion in those patients who were implanted with the device.
The patient also alleged that the device lacked warnings or included inadequate warnings to alert the patient, her physicians, and others of the severe and life threatening complications and risks associated with use of the product including vaginal erosion, infection, extrusion, perforation and/or abscess. In addition, the patient stated that her physicians did not and could not have known at the time of her surgery, or any time prior, of the existence of the defective and unreasonably dangerous condition of Mentor’s transobturator vaginal sling devices.
The case is Civil Action No. 4:12-cv-176 (CDL).
Attorneys: Austin Gower (Charles Gower Law Offices) for Teresa Taylor. John Q. Lewis (Tucker Ellis, LLP) for Mentor Worldwide LLC and Mentor Corp.
Companies: Mentor Worldwide LLC; Mentor Corp.
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