Johnson & Johnson has lost a $5.7 million verdict in a lawsuit over Ethicon’s TVT-Abbrevo device, Associated Press reports. These devices, which are used to treat pelvic organ prolapse and stress urinary incontinence, have come under scrutiny in recent years due to safety concerns. Ethicon is one of seven manufacturers being sued over transvaginal mesh implants.
The plaintiff in the case alleged pain and urinary problems after receiving the implant in 2011. A jury in Bakersfield, California found that the device was defectively designed and that the company failed to warn about the risks, awarding $700,000 in compensatory damages and $5 million in punitive damages. J&J said it planned to appeal, AP reports.
There are thousands of lawsuits pending over pelvic mesh devices. A number of cases are consolidated in a multidistrict litigation (MDL) centralized in the U.S. District Court for the Southern District of West Virginia before U.S. District Judge Joseph Goodwin. On March 2, Ethicon began trial for a bellwether case in this litigation, which includes some 23,000 lawsuits. Ethicon lost the first trial last September and was handed a $3.27 million verdict.
As cited in many cases, transvaginal mesh implants were not clinically tested for safety or efficacy before they were put on the market because they were approved through 510(k). This process allows a device to be sold without testing if manufacturers can prove that it is “substantially equivalent” to device that is already on the market.
In 2008, the U.S. Food and Drug Administration (FDA) said that the most common complications associated with mesh implants are erosion through the vagina (also called exposure, extrusion, or protrusion), pain, infection, bleeding, pain during sexual intercourse, organ perforation and urinary problems. The agency said in 2011 that these complications are “not rare”, warning that these devices may put patients at greater risk compared to tradition non-mesh procedures for POP.