For women over the age of 50, urinary incontinence is a common occurrence. Often a uro-gynecologist will suggest a bladder sling to hold up a prolapsed bladder and reinforce muscles that control the flow of urine.
But many women have problems with the slings and find they must eventually be removed. A lawsuit filed against Johnson & Johnson (J&J) has led to a request for documents necessary to try a product liability lawsuit over Mentor Corp.’s ObTape bladder sling.
A federal judge in Georgia ordered J&J and its subsidiary, Ethicon Endo-Surgery to produce documents in a case against Mentor Corp. Mentor is now owned by J &J after it was acquired in December, 2008 for $1.07 billion.
The Mentor sling is not made of woven material. That means for many women, such as plaintiff Geraldine Doria who has sued Mentor, the sling can block nutrients and oxygen. That can lead to severe pain, and vaginal extrusions, urinary tract erosion and infection.
Doria says the mentor sling has caused significant mental and physical pain since the device was implanted in February, 2005. To complicate matters, the device in her case caused “erosion of her internal bodily tissue, including her vaginal wall and painful infection.” It had to be surgically removed, which often proves difficult.
Doria subpoenaed records from Ethicon related to another product, the Gynecare TVT prolene mesh device, but Ethicon says they’re not relevant to this case and that they contain trade secrets. Ethicon said the subpoena presents an undue burden, but Judge Clay Land of the US District Court for Middle Georgia denied the Ethicon motion, ruling the company must produce the records.
The plaintiff’s content that the Ethicon product, TVT, is a safer feasible alternative design over the ObTape design and that information regarding the TVT design is relevant to a design defect claim and to refute Mentor’s clam that its design is as safe as the TVT design. Judge Land also ruled that Ethicon must produce a pamphlet for the TVT device about how to select the right mesh.
Many consumers may not know that often medical devices do not go through a pre-market approval process the way drugs are required to do. In this case, the Mentor tape cited Ethicon‘s TVT device as its predicate device. That means in its application for approval, Mentor said it was substantially equivalent to TVT. That’s why it did not have to undergo pre-market approval under the 510(k) application, as it’s known by the FDA.
In December, Judge Land decided to allow Mentor Corporation founder and CEO and its president to be deposed by the plaintiffs and reversed his decision to dismiss the case on preemption grounds. #
Source Article: http://massdevice.com/node/5485
