C.R. Bard ($BCR) has settled 3,000 cases by women injured from its vaginal mesh for more than $200 million. This is the latest in a parade of large settlements in recent months over the implants, which are said to cause pain and internal damage, from the likes of Endo International ($ENDP), Medtronic ($MDT), Boston Scientific ($BSX) and Johnson & Johnson ($JNJ).
The Bard settlement addresses about one-fifth of the outstanding lawsuits related to the vaginal inserts, Bloomberg reported. They are typically used in older women who have experienced vaginal prolapse during surgical repair.
Despite the slew of lawsuits, settlements and the FDA recently cleared a new tranvaginal mesh product and companies, including Bard, continue to market the surgical inserts. The agency hasn't been quick to act. Since 2011, it has said that serious complications for transvaginal repair of pelvic organ prolapse are not rare--and that it's not clear that the use of mesh in that repair is more effective than a surgical repair that does not include the use of mesh.
In addition, the FDA is in the midst of considering a reclassification of pelvic mesh from a moderate risk, or class II device, to a high-risk device, which is class III and requires a full premarket approval (PMA) application.
In the Bard cases, a judge had advised late last year that the company aggregate and settle them. The plaintiffs will each get about $67,000, which is more than the average $43,000 payout in a smaller deal last year, Bloomberg noted. But some individuals have been awarded millions for a single case, depending solely on jury decisions.
Bard CFO and SVP Christopher Holland said on the company's latest earnings call that it took a $344 million charge during the second quarter, "primarily related to pelvic health product litigation."
- here is the Bloomberg story