Yesterday, Johnson & Johnsons lawyers informed class action Judges, Judge Goodwin (West Virginia) and Judge Higbee (New Jersey), that it is will stop selling Prolift Vaginal Mesh. Now, J&J is not calling it a recall. But the difference between stop selling and recall is purely semantics. Importantly, J&J has asked the FDA to place the existing 522 orders requiring additional studies for these products on hold.
Background: What Is Vaginal Mesh?
Vaginal mesh (also called transvaginal mesh, vaginal slings, transvaginal slings, and bladder slings) is a medical device that is surgically implanted to treat a condition called pelvic organ prolapse. These products have an extremely high rate of failure, and cause problems including infection, pelvic pain, punctured organs, urinary problems, and erosion of the mesh into the vagina. These are horrible, almost unspeakably embarrassing injuries.
There are many manufacturers, including C.R. Bard (Avulta) , AMS, Johnson & Johnson (through Ethicon), Boston Scientific, UGYTEX, and Covidien.
What Products Are Being Recalled?
Johnson & Johnson is ending sales of the following products in the United States:
- GYNECARE TVT SECUR
- GYNECARE PROSIMA Pelvic Floor Repair System
- GYNECARE PROLIFT Pelvic Floor Repair System
- GYNECARE PROLIFT+M Pelvic Floor Repair System
There is one product that is not being discontinued, but which will feature updated labeling–the GYNECARE GYNEMESH PS.
What Will The Court Do?
The lawyers in the Vaginal Mesh cases have a case management conference set in West Virginia in July. Right now, especially in light of this Prolift recall, plaintiffs’ lawyers will likely file the remainder of their Prolift vaginal mesh cases. The judge seems encouraged to start setting trial dates, which is a good sign that the cases may begin settling. Settlements routinely occur just before and after these initial trials in cases like this.
The parties are still working on some remaining discovery issues, and working on creating Plaintiff Fact Sheets (PFS) and Defendant Fact Sheets (DFS). The Fact Sheets are agreed-upon documents that each plaintiff and defendant fills out to provide the opposing side with some good preliminary information. Plaintiffs will disclose their medical and surgical history, demographic information, and other relevant information.
Phoenix, Arizona product liability lawyer Stephen I. Leshner is currently handling transvaginal mesh (TVM) cases. Please contact Steve for a free consultation if you or someone close to you has been injured by a defective TVM product.