In the first case involving vaginal mesh to go to trial, medical manufacturer C.R. Bard Inc. has been handed a $5.5 million dollar verdict. The trial, which was held in California, revolved around a woman whose vaginal-mesh implant left her incontinent and in chronic pain.
Christine Scott and her husband were awarded the damage award because of injuries caused by Bard’s Avaulta Plus product. The jury found that Bard was negligent in their handling of the vaginal implant devices; devices which were used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
While Christine and her husband’s case may have been the first to go to trial, it is only the beginning. Hundreds of lawsuits have been initiated against Bard and other manufacturers regarding vaginal implants because of injuries women have suffered.
Manufacturers Johnson & Johnson, American Medical Systems, Bard, Boston Scientific Corp., and several others are among those facing allegations that their implants caused multiple problems including organ damage.
Even after Christine Scott’s verdict, Bard still is proclaiming innocence. “While we empathize with the complications suffered by the plaintiff, those complications are not the fault of any conduct by the company,” Scott Lowry, a Bard spokesman, said in a follow-up statement.
Nevertheless, what the jury saw seemed to paint a different picture. The past and ongoing actions of many of these manufacturers, not just Bard, display a sense of disregard for patient’s safety that cannot be ignored.
In 2008, the FDA issued a Public Health Notification stating that the issues with the use of synthetic vaginal mesh was a growing concern, and as recently as January the FDA ordered 33 manufacturers of vaginal mesh devices to conduct post-market safety studies on their products.
Johnson & Johnson, the biggest health-care products maker, continued to sell a vaginal mesh implant for nine months after U.S. regulators told the company to stop marketing the device. This information is even more troubling, when it’s partnered with the fact that Johnson & Johnson marketed their Gynecare Prolift device for three years before the FDA even approved its use.
Earlier this summer, Johnson & Johnson’s Ethicon halted the sales and marketing of four vaginal mesh implants.
On July 13th, 2011, the FDA released an updated safety concern that stated "serious complications associated with surgical mesh for transvaginal repair of POP are not rare” and "this is a change from what the FDA previously reported…Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk."
These factors are just a few of the concerns that have surfaced since allegations involving these devices began.
In February, the U.S. Judicial Panel on Multidistrict litigation (JPML) issued an order consolidating several vaginal mesh multidistrict litigations into a single proceeding to be heard in the Southern District of West Virginia. The cases are against Bard, Johnson & Johnson, American Medical Systems, and Boston Scientific.
The first trial in those cases is set for February 5th, 2013.