Johnson & Johnson is facing more than 12,000 lawsuits stemming from improperly designed vaginal inserts (a.k.a. slings) that would erode and shrink over time, leading to damaged organs and pain during sexual intercourse.
In the U.S. in 2010 alone, doctors implanted more than 70,000 mesh devices into patients. The process involves threading the devices through a series of incisions in the vagina. The device then acts to fortify pelvic muscles that fail to support internal organs and/or to treat incontinence.
Due to the number of lawsuits, the U.S. Food and Drug Administration (FDA) has ordered J&J and 32 other vaginal-implant makers to study the rates of organ damage and any other complications that can/are linked to the implants. J&J’s lawyers counter that the FDA found the TVT Retropubic sling to be safe and effective for use in women. Furthermore, J&J claims that the device continues to be considered “gold standard” for incontinence treatments.
Lawsuit Details
J&J was ordered to pay $1.2 million to a Texas woman, Linda Batiste, who claims she suffered pelvic pain when the implant used to treat her incontinence eroded inside of her.
Last year, in the first of the lawsuits involving any of the company’s implants, J&J was ordered to pay $11.1 million to a New Jersey woman. Her claims cite that her Prolift device—implanted to help support sagging organs—shrank and frayed which led to bladder and vaginal damage.
Further Woes for Johnson and Johnson
In addition to the current lawsuit(s) due to defective products, J&J is also accused of improperly destroying files about some of the vaginal-mesh implants.
The division of J&J involved in the scandal is the Ethicon unit, which makes Gynecare Prolift and TVT Retropubic meshes. Ethicon allegedly lost or destroyed thousands of documents and computer files surrounding the development of devices from 2007. Ethicon officials blame the loss (and possible destruction) of the documents on their document-retention system. Officials state that they have knowledge that their system “failed miserably in certain instances”.
There is no evidence that Ethicon officials deliberately attempted to keep vaginal-mesh files out of court. Nevertheless, officials were negligent in the process of handling files and for allowing some juries to hear about the document destruction.
Lawsuits for J&J are still going on. If you believe you or one of your family members has been a victim of defective vaginal-mesh inserts or any other medical device, please schedule a free consultation with a defective medical product attorney at Gilreath & Associates today. Click here to learn more about defective medical devices, or continue browsing our blog and knowledge center for more about ongoing investigations, lawsuits and more.