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Mentor Corp Wins First Verdict

by Joan Trombetti, Writer | January 07, 2009
OBTape System
The manufacturer of a medical device used to treat a form of urinary incontinence in women is heralding a recent court verdict as dozens of lawsuits alleging problems tied to the product have been consolidated and head to their first pretrial hearing this month.

In the past year and a half, 32 lawsuits have been filed against Mentor Corp., a Santa Barbara, Calif.-based cosmetic surgery device manufacturer that, in 2003, launched the OBTape, 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.

In October, the U.S. Food and Drug Administration, while not singling out OBTape, issued a generic alert to doctors warning of complications in surgical mesh devices designed to treat stress urinary incontinence, such as infections, pain and scarring, and erosion of the vaginal wall, many of which are at the heart of the claims in the lawsuits.

Last month, a jury in California issued the first verdict in an OBTape case, ruling against a plaintiff's claims. But the additional plaintiffs' lawyers said the ruling would have little effect on their cases and anticipate filing more suits over OBTape.

"What they're claiming is that because of the defective device, this OBTape, these women have experienced serious medical injuries and problems," said Gary Blasingame, a partner at Athens, Ga.-based Blasingame Burch Garrard & Ashley, who is handling the bulk of the OBTape cases. "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."

Of the 32 cases filed against Mentor, 29 are in federal courts in various states. The other three are filed in state courts in California. Last month, 22 of those actions were consolidated in multidistrict litigation before U.S. District Judge Clay D. Land of the Middle District of Georgia. In re Mentor Corp. OBTape Transobturator Sling Products Liability Litigation, No. 4:08-md-02004 (M.D. Ga.).

The suits, which were filed in California, Florida, Georgia, Louisiana, Missouri, New Jersey, New York, Ohio and Oklahoma, involve allegations of negligence, failure to warn and breach of warranty on behalf of multiple women and, in some cases, claims for loss of consortium on behalf of their husbands.

Blasingame said he has another half dozen suits in the works, with possibly more to be filed. James S. Rogers, a solo practitioner in Seattle, who has filed one of the federal cases that was recently consolidated, said he plans to file another suit in California on behalf of five plaintiffs and one in Minnesota, where Mentor is incorporated, on behalf of three plaintiffs.