A Philadelphia jury recently returned a verdict against Johnson & Johnson, awarding $20 million to a New Jersey woman who alleged the company’s vaginal-mesh device left her in constant pain.
The verdict was the third consecutive multimillion-dollar award against J&J in a mesh case in the Philadelphia courts. Johnson & Johnson is preparing for a wave of trials over the surgical mesh devices and the injuries and complications women have reported.
Failure to Warn of Pelvic Mesh Risks
This latest award consists of $2.5 million in compensatory and $17.5 million in punitive damages. The plaintiff, a 56-year-old Pennsylvania woman, alleged that the Ethicon TVT-Secur mesh device was defective and that the company failed to warn of its risks. The lawsuit alleged that Ethicon-a division of J&J-continued to market the transvaginal tape device despite knowing the injuries it caused to patients.
Parker Waichman notes that Johnson & Johnson is not alone in facing legal difficulties over transvaginal mesh products. Other manufacturers, including C.R. Bard, Boston Scientific, and American Medical System, are named in thousands of lawsuits or proposed settlements of vaginal mesh injury claims. In addition, the surgical mesh used in hernia repair is also alleged to cause injuries and complications.
Symptoms Return a Month after Surgery
In 2007, the plaintiff had surgery to treat stress urinary incontinence, a condition in which a woman experiences urine leakage when she sneezes or coughs or during exercise, for example. A TVT-Secur device was implanted during the surgery. But the woman’s 2013 lawsuit alleges that the TVT-Secur implant failed within a month and the leakage problem returned. The mesh then began eroding within her body. She had three more surgeries, but doctors were not able to remove all of the mesh. The woman says she now has chronic vaginal pain, pelvic floor spasms, and permanent urinary dysfunction.
After the verdict, the plaintiff issued a statement saying she was “happy [to] be a voice for other women.” She described her experience as a “nightmare,” but said she felt justice “was truly served” by the verdict.
Transvaginal Mesh Devices
The U.S. Food and Drug Administration (FDA) approved transvaginal mesh devices in 1996 to treat urinary incontinence and in 2002 granted approval for mesh devices to treat pelvic organ prolapse. These conditions afflict women when the pelvic structures that support the uterus, bladder and intestines weaken due to childbirth, surgery, or aging. The organs can drop (prolapse) into the vagina, causing incontinence and bowel and sexual problems. Transvaginal mesh devices are implanted to provide support for the organs.
But women who have had vaginal mesh devices implanted report serious, sometimes permanent, injuries and side effects following the implant. Common side effects include:
- mesh erosion through the vagina (also called exposure, extrusion, or protrusion)
- pain
- infection
- bleeding
- pain during sexual intercourse
- organ perforation
- urinary problems
Many women have undergone additional surgery to attempt to remove the mesh and to repair organ damage. These surgeries, however, are often not successful. Some women have been caught in a cycle of repeated episodes of mesh erosion and surgery to remove protruding mesh.
FDA Warnings
In a 2011 safety communication for women and health care providers, the U.S. Food and Drug Administration (FDA) said serious complications associated with transvaginal mesh “are not rare.” Further, the agency said, it is “not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”
In January 2016, in response to thousands of lawsuits and reports of mesh failure and complications, the FDA issued two orders for transvaginal mesh devices. The first order reclassifies vaginal mesh devices from Class II, the moderate-risk device category to Class III, the high-risk category. The categories are assigned depending on how likely it is that a particular device will cause serious and permanent health consequences or even death. The second FDA order requires vaginal mesh manufacturers to submit premarket approval (PMA) applications to support the safety and effectiveness of their vaginal mesh devices.
Transvaginal Mesh Litigation
In addition to the recently decided case, other litigation includes:
- the Philadelphia pelvic mesh mass tort docket has 183 cases pending, with a trial scheduled to begin on May 8.
- the U.S. 4th Circuit upheld a $3.27 million Ethicon pelvic mesh verdict.
- 32,370 lawsuits are filed against J&J in a multidistrict litigation in the Southern District of West Virginia before U.S. District Judge Joseph R. Goodwin.
J&J has lost at least five jury awards totaling more than $35 million over the mesh devices since 2014 and the company has settled other cases, including one for as much as $5 million. The company has won several cases, including a 2015 lawsuit in Texas. J&J is appealing some of the plaintiff’s wins, including the latest verdict. Ethicon spokeswoman Kristen Wallace said the company would appeal the findings that the devices were defective and that the company failed to provide adequate warnings about the risks.
But Carl Tobias, who teaches product liability law at the University of Richmond in Virginia, believes J&J should consider a comprehensive settlement to all the cases. “There’s no sense in continuing to shell out for the defense costs and suffer the reputation damage that comes with each win by the plaintiffs.” Tobias explains.
Johnson & Johnson has voluntarily pulled four lines of mesh inserts, including the TVT-Secur device, off the market after facing a wave of litigation. Ethicon is the J&J unit that sells the mesh.
The decision to stop selling the pelvic mesh devices came six months after regulators ordered J&J and more than 20 other makers of such devices, designed to treat incontinence and shore up weakened pelvic muscles, to conduct further studies about their health risks.
Help for Women Who Have Suffered Transvaginal Mesh Injuries
If you have suffered injuries or complications from a pelvic mesh injuries or have needed additional surgery to remove the mesh or repair organ damage, the attorneys at Parker Waichman LLP can help determine your legal options. To contact the firm for free, no- obligation case evaluation, fill out the online contact form or call 1-800-YOURLAWYER (1-800-968-7529).
