Mentor ObTape Lawsuits Proceeding

Legal action on behalf of women injured by the <"">Mentor ObTape Vaginal Sling is proceeding with four cases scheduled for trial in California. In an order dated March 30, 2010, the California Superior Court denied Mentor Corporation’s motions to dismiss in four of the lawsuits, refusing to dismiss two of the cases on statute of limitations grounds. Johnson and Johnson now own Mentor.

The Mentor ObTape is a transobturator vaginal sling used in thousands of women between 2003 and 2006 to surgically treat Stress Urinary Incontinence (SUI). The Mentor ObTape was made with a “nonwoven,” “small pore” design, which has been found to slow tissue integration, leading to debilitating side effects. Women implanted with the Mentor ObTape have suffered severe pain, vaginal extrusions, urinary tract erosions, and infections. Some estimates have suggested complication rates in excess of 17 percent.

In rejecting Mentor’s position that the plaintiffs’ claims were time barred, the Court found that there are disputed facts as to whether Mentor concealed the danger of ObTape from plaintiffs’ doctors. Plaintiffs have alleged Mentor knew as early as 2003, long before the plaintiffs’ were implanted with ObTape, that its true erosion rate was much higher than the .21 percent touted by its representatives to physicians. Because of this, plaintiffs could not have known their injuries were due to Mentor’s wrongdoing at the time their ObTapes were removed in 2004 and 2005. They were not suspect until 2008, when, for the first time, they learned that ObTape had an alarmingly high rate of erosion.

In a study recently released at the end of 2009, further supporting the claims in the lawsuits, it was estimated that approximately one in five patients implanted with ObTape would suffer a complication in which the device would erode through their vagina. While this study, along with others that were published just as Mentor decided to remove the product from the market, estimate alarmingly high rates of injury, Mentor has never advised patients or their physicians of these increased dangers.

“The decision in these cases may open the courthouse door to many injured women who would otherwise be denied,” said Andres Alonso, a partner of Parker Waichman Alonso LLP; plaintiffs in the case are being represented by the firm. “Given that 16,000 Mentor ObTape slings were sold in the three years the device was on the market, the lawsuits currently filed are only the tip of the iceberg,” Alonso added.

In too many cases women were forced to undergo multiple surgical procedures to remove tape segments, which had failed to properly integrate into the surrounding tissue. Oftentimes tape removal did not provide victims with complete relief. Even after complete removal of the tape, some women have been left with permanent and debilitating injuries. Though never formally recalled, sales of the Mentor ObTape ended abruptly in 2006, a short three years after its introduction to the U.S. market.

In 2008, all Mentor ObTape lawsuits pending in federal court were consolidated in a multidistrict litigation (MDL) in the U.S. District Court for the Middle District of Georgia before the Honorable Judge Clay D. Land. The first MDL trial is scheduled to begin in June, and Judge Land has already ruled that four cases in the multidistrict litigation will be tried at once.

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