J&J's Mentor Corp. settles ObTape liability lawsuits

June 9, 2010 by MassDevice staff

Johnson & Johnson (NYSE:JNJ) subsidiary Mentor Corp. agreed to settle a group of lawsuits filed against it over an allegedly defective device designed to treat female urinary incontinence.

The class action suits, consolidated in the U.S. District Court for Middle Georgia, involved Mentor's ObTape device for women suffering from stress urinary incontinence. The device was designed to provide support to the vaginal wall by reinforcing the muscles that control the flow of urine. Unlike other, similar devices, the Mentor product was not made of woven material, meaning it could block nutrients and oxygen, allegedly causing severe pain, vaginal extrusions, urinary tract erosion and infection. In some cases the device had to be surgically removed, according to court documents.

A jury trial that began June 1 was halted June 7, after the parties informed Judge Clay Land of the settlement. Land gave them until early September to tell him whether the settlement is consummated, according to court documents. The settlement only covers cases pending in Georgia's Middle District; Land ordered the parties to also inform him of the status of other pending cases against Mentor over the sling.

If the settlement clears, it would bring to a close a tumultuous case for one of the plaintiffs, Geraldine Doria. Doria sued Mentor after experiencing significant mental and physical pain after a surgeon implanted her with the device Feb. 4, 2005. The device caused "erosion of her internal bodily tissue, including her vaginal wall ... and painful infections," according to her original complaint, and eventually had to be surgically removed.

In August 2009, Land tossed Doria's case on preemption grounds, ruling that laws in New Jersey (where Doria's case was originally filed) did not permit "punitive damages generally are not permitted in product liability actions regarding medical devices approved by the federal Food & Drug Administration," according to court documents.

But in November of that year Land reversed himself, after Doria asserted that the New Jersey statute is limited to devices cleared under the FDA's pre-market approval process and that the watchdog agency recognizes as safe and effective. The ObTape device was cleared via the FDA's less stringent 510(k) protocol.

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