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Suits Pile Up Over Controversial Medical Device for Women
As 22 federal cases over ObTape are consolidated, manufacturer wins first verdict
The National Law Journal
January 06, 2009
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 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."
CONSOLIDATING IN GEORGIA
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.
A pretrial hearing on the federal actions is set for Jan. 19.
More suits are coming. Blasingame said he has another half dozen suits in the pipeline, with possibly more to be filed. James S. Rogers, a solo practitioner in Seattle, who has filed one of the federal cases that recently got 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.
He said the recent verdict would have little impact on the other cases because the facts and injuries are different from one another. In that case, the plaintiff, Lisa Ann Seeno, suffered from infection and erosion of her pelvic organs after having the ObTape surgically implanted in November 2004. She also needed additional surgeries for her injuries. Seeno v. Mentor Corp., No. RG06264787 (Alameda Co., Calif., Sup. Ct.).
She sued in 2006, alleging that Mentor was negligent in designing the product and failed to warn about the risks associated with the ObTape. On Dec. 15, the jury found for Mentor on both counts, concluding that doctors knew of the risks associated with ObTape.
"We think it's very telling that a jury can understand the safety and efficacy of the product," said Ed Sebold, a partner in Houston office of Jones Day, who represents Mentor. "While it doesn't necessarily stop any future cases, we think it's an important point and shows these particular concepts can be heard by folks that hear all the data."
Seeno's lawyer, Khaldoun Baghdadi, a partner at San Francisco's Walkup, Melodia, Kelly & Schoenberger, said a "severe evidentiary ruling" affected the jury's decision, which he planned to appeal. "As such, a majority of the unfortunate facts surrounding ObTape and its withdrawal from the market have yet to be presented to a jury," he said.
