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| Johnson & Johnson is facing thousands of lawsuits over its Prolift device.--Courtesy of Johnson & Johnson |
Johnson & Johnson ($JNJ) is facing thousands of lawsuits over its Gynecare Prolift vaginal mesh implant, and lawyers for the plaintiffs say the company was warned of problems with the devices long before it chose to sell them anyway.
According to Legal-Bay, a settlement outfit, witnesses have testified that J&J subsidiary Ethicon was advised that Prolift lacked the proper design to remain safe after implantation but chose to proceed to market anyway. Then, in 2007, J&J kept the devices on the market for four months after the FDA demanded that they be pulled.
Plaintiffs contend that J&J failed to adequately warn them about the devices' risks, resulting in scarring, pain, nerve damage and organ perforation from a product they say was defective. J&J contends that it did nothing wrong, getting 510(k) clearance for the devices and marketing them under FDA guidelines. In June, J&J announced that it would stop selling four of its vaginal mesh products but has not recalled the ones already on the market.
The first of many Prolift trials kicked off last month in New Jersey, and the industry is likely keeping a close eye on what develops, as more than 100,000 suits have been filed against the likes of Boston Scientific ($BSX), C.R. Bard ($BCR) and Covidien ($COV) over their vaginal meshes.
For its part, the FDA has asked makers of meshes to submit three-year study data on rates of organ damage and related complications, considering a reclassification that would require the devices to go through the PMA process, much like the agency wants to do with all-metal hips.
- read the announcement