Jury deliberations are underway in a case brought against health care products giant, Johnson & Johnson, over one of its Ethicon units’ transvaginal mesh device products.
The plaintiff, Linda Gross, 47, is a nurse from South Dakota who was just awarded $3.35 million in compensatory damages in the first of some 2,100 lawsuits brought in New Jersey over the device, said Bloomberg.com. Gross’s attorneys are asking jurors to mandate the drug maker now pay punitive damages. The jury in the case found that Johnson & Johnson neglected to warn the plaintiff’s surgeon of the risks associated with the Gynecare Prolift implant and deceived Gross about the device’s risks.
In New Jersey, there is a cap on punitive damages of five times the amount of compensatory damages. In this case, said Bloomberg.com, that amount would be $16.75 million; however, the jury has not been provided with that information. Gross’s attorney asked the jury to “Tell them through your verdict, don’t do this again, change your way of business…. You’ve already found they knew what they were saying was untrue. When you make a punitive damage award and you want to deter them, you take into account how much money they have,” according to Bloomberg.com.
The lawsuit, brought by both Gross and her husband, alleged her ongoing pain and that she had to endure 18 surgeries following implantation with the Prolift transvaginal mesh device. As we’ve explained, transvaginal mesh implants are medical devices approved to treat pelvic organ prolapse (POP), a condition in which weakened pelvic muscles cause organs to slide out of place. The device is also approved to treat stress urinary incontinence (SUI) and is meant to strengthen pelvic walls.
Johnson & Johnson denies Gross’s claims and maintains that the Prolift is safe and effective and that it appropriately warned of the device’s risks, said Bloomberg.com. “I understand that Johnson & Johnson and Ethicon didn’t do as good a job as they could have,” said, Christy Jones, Johnson & Johnson attorney, speaking to the jury in what Bloomberg.com described “a voice barely above a whisper.” Jones added, “I understand they could have given better warnings” to Gross’s surgeon. The device maker faces some 4,000 transvaginal mesh lawsuits nationwide. Meanwhile, in closing arguments on February 15, a Johnson & Johnson attorney said, “Our position is that the Prolift is a safe and effective product, that Ethicon adequately warned doctors of the risks, that doctors knew of the risks,” according to a prior Bloomberg.com report.
The Ethicon Prolift is constructed of a polypropylene mesh inserted through a vaginal incision, Bloomberg.com explained. Last June, Ethicon announced it would no longer sell four types of transvaginal mesh devices, including the Prolift + M™, TVT Secur, Prolift, and Prosima. And, as we’ve written, the U.S. Food and Drug Administration (FDA) warned that complications associated with transvaginal mesh implants are “not rare.” The agency also stated that no clear evidence exists that transvaginal mesh is better than non-mesh methods for treating POP and SUI and has asked 33 manufacturers to conduct post-market studies evaluating the dangers of transvaginal mesh.
Complication reports, mounting litigation, and concerns over the lack of clinical testing have raised questions about the devices’ safety and efficacy. The devices were approved through a fast-track process known as the 510(k). Under the 510(k), a formal review for safety and efficacy is neither required nor performed. Because the 510(k) route has been used to gain clearance for other controversial products, such as metal-on-metal hip implants, the process has drawn increasing criticism.
As we’ve explained, thousands of women were recipients of transvaginal mesh devices, which have come under increased scrutiny since many recipients of these devices began experiencing complications related to their defects. According to an agency Safety Communication issued last summer, the most common reported adverse events related to transvaginal mesh includes: Mesh erosion through the vagina (exposure, extrusion, protrusion); pain; infection; bleeding; pain during sexual intercourse (dyapareunia); organ perforation; and urinary problems. Of note, not all of the very serious reactions to which transvaginal mesh has been associated are physical.
In fact, regarding the alleged risk of erosion, in which the transvaginal mesh travels through the body’s tissues, the device can become embedded in inappropriate areas, leading to multiple surgeries to remove the device. Sadly, in many cases, erosion is so significant and widespread that the mesh cannot ever be completely removed.