The legal lollapalooza over transvaginal mesh implants has spilled over north of the border, where a class action lawsuit against Johnson & Johnson (NYSE:JNJ) was filed accusing the health care giant of failing to adequately warn of the devices’ risks.
The FDA warned last year about possible complications from the mesh, which is used to treat female urinary incontinence, detailing a grim list of possible side effects including pain during intercourse and urination, vaginal and urinary infections and injuries to the bowel, bladder and vagina.
The watchdog agency’s warning helped turn the steady flow of U.S. lawsuits into a flood. Patient advocacy groups have called for a mandated recall after an internal FDA research group recommended that additional clinical testing be required for new transvaginal mesh products. The agency itself asked a total of 33 companies to conduct 3 years of safety and effectiveness trials after deaths and injuries linked to the products spiked in recent years.
In December 2012 a trio of U.S. senators probed C.R. Bard (NYSE:BCR) on its management of the clamor surrounding its transvaginal mesh devices, part of a larger investigation into medical device recalls, including for Medtronic’s (NYSE:MDT) 2007 Sprint Fidelis recall and Zimmer Holdings (NYSE:ZMH) for its NexGen knee implant.
Although the lawsuits have brought the FDA’s role in approving the devices into the spotlight, the accusation that J&J sold the devices for 3 years without proper approval (which the company denies) has put the New Brunswick, N.J.-based conglomerate in an even worse light.
In a statement, J&J subsidiary Ethicon said it expects to be vindicated.
"We are confident the evidence will show that Ethicon acted appropriately and responsibly in the research, development and marketing of these products," the company told CTV News.
Matthew Baer, who’s representing some of the Canadian women bringing the class action there, said the suit is aimed at making sure women are aware of the risks posed by mesh products.
"One of the key components of the class action, is to make sure there is a proper warning put in place that reflects the magnitude of the risks and the failure rate so that doctors and patients can make informed decisions," Baer told the station.
First trial in DePuy ASR brouhaha set for December
South of the border, another J&J division, DePuy Orthopaedics, is girding for the first of many legal battles over its recalled DePuy ASR hip implants.
A Nevada judge set Dec. 3 as the date for the trial, the first in the U.S. over the ASR implant, according to a lawyer for 1 of the 3 plaintiffs in the suit, filed in a Nevada state court.