Now that the federal vaginal mesh bellwether lawsuits have started to move forward, the presiding judge has set the first trial against Johnson & Johnson subsidiary Ethicon to begin in August 2014. The case that the trial will focus on has not been chosen yet, but is expected to be picked early next year.
The judge for the bellwether case is U.S. District Judge Joseph R. Goodwin, who is currently presiding over six different federal MDLs involving the vaginal mesh devices made by various manufacturers, including Johnson & Johnson’s Ethicon unit, C.R. Bard, American Medical Systems (AMS), Boston Scientific, Coloplast and Cook Medical. The FDA gave weight to the women’s claims when the agency stated that these types of complications are not rare. FDA officials even went so far as to express that the “devices may actually be more harmful when compared to alternative methods for treating POP.”
The complications linked to the devices that have caused all of the lawsuits include organ failure, infection and erosion. Many of the devices had to be surgically removed as a result of the complications. Vaginal mesh devices are used to treat stress urinary incontinence and pelvic organ prolapse, conditions caused by menopause and/or childbirth.
Most of the lawsuits that have been filed accuse the manufacturers of not properly warning the public or healthcare professionals of the dangers linked to the mesh, and of negligence and promotion of products known to be harmful. A recent study even found that the risks involved with having a vaginal mesh device implant outweighs the benefits in treating POP. That study had to be halted after three patients died after having the mesh implanted and another three had to have the devices removed. The deaths have not been fully linked to the device’s use. The results of that study have been published in the journal Obstetrics and Gynecology.