Pickett Dummigan has represented injured women in this field since 1999, having successfully litigated cases involving a similar product - the Protogen sling - until the FDA forced a recall of the product.
ObTape is a product designed to treat female urinary incontinence. It is designed and sold by Mentor Corp., based in Santa Barbara, CA, and recently acquired by Johnson & Johnson. They stopped selling ObTape in 2006 but say there is nothing wrong with the product, which was cleared for sale by the Food and Drug Administration.
One of the common excuses is provided by John Q. Lewis of Cleveland, a lawyer with the firm Jones Day, which represents Mentor. He said that there were risks to any surgical procedure and that doctors should have warned patients. He noted that early European studies reported low rates of complications with ObTape.
In ObTape's case, the chain of similar claims can be traced back to an older product that caused so much harm it was taken off the market. That recall did not stop the FDA from clearing a new generation of vaginal slings whose only claim to safety was their similarity to the flawed device.
In 2003, Mentor asked the FDA to clear ObTape for the U.S. market, saying there was essentially no difference between its product and two other vaginal slings already widely in use - Johnson & Johnson's Tension Free Vaginal Tape System and American Medical Systems' Sparc Sling System.
Those slings had been cleared earlier, based on claims that they, too, were much like earlier products - in Johnson & Johnson's case, the Protegen sling, made by Boston Scientific. The Protogen sling had been recalled in 1999, four years before ObTape made its appearance. At the time, the FDA called the Protegen sling an 'adulterated and misbranded' product.
As further evidence of the problems associated with ObTape, in 2006, doctors at the Virginia Mason Medical Center in Seattle reported in the Journal of Urology that they had stopped using ObTape after observing a 13.4 percent rate of vaginal extrusion.
If you or a loved one has had this product surgically placed and have any concerns at all about its safety we invite you to call for a free consultation. Our firm has been involved representing injured women in this field since 1999 when the Protogen sling was recalled.
The following verdicts and settlements are representative of the types of cases the attorneys at Pickett Dummigan LLP accept. Your results may vary.
Confidential seven figure settlement on behalf of a young mother who suffered a profound brain injury during birth.
Confidential seven figure settlement on behalf of the estate of a young woman who died as a result of pregnancy induced hypertension.
Confidential six figure result involving a young child who suffered severe nerve injuries to her arm and hand.