Lawsuits Consolidated against Manufacturer of Defective Urinary Device

Posted by Beth JanicekJanuary 07, 2009 10:03 AM

I wrote a blog last month about the FDA’s quick review of certain medical devices and I referenced a “fast-track” approved device meant to help women with urinary issues but the device ended up being recalled. Similar urinary devices have made the news again due to recent lawsuits against a device manufacturer. The problematic device is a sling that is surgically implanted to treat stress urinary incontinence, which often is brought on by coughing, sneezing or exercise, and is common in women after childbirth. The product was removed from the market in 2006.

Now there are 32 pending lawsuits against Mentor Corp., a Santa Barbara, Calif.-based cosmetic surgery device manufacturer. The Plaintiffs claim Mentor was negligent in their design of the ObTape device and that they failed to properly warn patients of the risks of injury created by the device. The FDA issued a general warning to doctors about potential risks connected to these slings but the FDA did not specifically name the ObTape device.

A recent California jury verdict came down in favor of Mentor because the jury concluded the doctors knew of the risks involved when they implanted the ObTape. But, the litigation does not end there; a U.S. District Court in Georgia recently consolidated 22 lawsuits against Mentor regarding the ObTape device. Gary Blasingame, a lawyer handling some of the women’s cases said, “What they’re claiming is that because of the defective device, this ObTape, these women have experienced serious medical injuries and problems. We think it's a significant series of cases, and we think this product is one that we have alleged in our complaint and anticipate will be proven is defective."