Medtech giant BD will pay $60m to settle a multistate litigation alleging that its subsidiary company C. R. Bard deceptively marketed transvaginal surgical mesh to patients and practitioners.
The discontinued devices were designed to treat pelvic organ prolapse and stress urinary incontinence, but became linked to severe, disabling side effects. These effects included nerve damage and chronic pain, vaginal scarring and shrinkage resulting from the erosion of the mesh inside of the body and cases of organ perforation. The implants have also been linked to several deaths.
The District of Columbia and every US state besides West Virginia and Wyoming are involved in the settlement, with the money to be divided up among them.
Evidence indicated that Bard was well aware of the serious complications but failed to provide sufficient warnings to customers or to the surgeons who implanted the devices. The implants were no longer being sold in the US by Bard when BD acquired the company for $24bn in 2017, with the litigation also predating the acquisition. Last year, the US Food and Drug Administration (FDA) ordered that all transvaginal mesh devices be removed from the US market.
BD denied any wrongdoing in a public statement, saying it chose to settle the matter “to avoid the time and expense of further litigation”.
Are lawsuits enough to stop this happening again?
This is the latest in a long line of lawsuits against former manufacturers of pelvic mesh, with Johnson & Johnson (J&J) and its subsidiary Ethicon making particularly substantial pay-outs over allegations that it marketed its transvaginal mesh products deceptively.
J&J paid out $10m to settle with the state of Washington in April 2019, $117m to settle with 41 states and the District of Columbia the following October, a staggering $344m to the state of California in January, as well as $4m to West Virginia in May in a lawsuit that also covered hip replacement systems. Oregon raised its own case against J&J last December.
But are settlements of this kind enough to truly deter other companies from this kind of deceptive marketing? BD bought out Bard for $24bn, after all, when the case against its vaginal mesh products was already underway – another $60m is almost small change in comparison.
Drugwatch senior writer Michelle Llamas says: “I think companies always respond to being hit financially as a deterrent from future negligent behaviour. But sometimes it takes a ruling from a regulatory agency such as the U.S. Food and Drug Administration, European Medicines Agency or other government entity to discourage it. In the US, the FDA required companies to provide data on safety and effectiveness of transvaginal mesh for POP. They didn’t find enough evidence that the benefits of these devices outweighed their risks, so they told all companies to stop selling it.”
Where does this leave patients?
While these state-wide settlements can provide some comfort to patients injured by the devices, they can be of little practical help for those facing a lifetime of complications. As a result, many patients enter into personal pelvic mesh lawsuits to cover the ensuing medical costs.
In April last year, a Philadelphia court ordered J&J to pay $120m in damages to Susan McFarland, a patient who underwent surgery to fit its TVT-O transvaginal mesh implant in 2008 to treat stress urinary incontinence. This remains the biggest payout issued to an individual patient to date.
Without transvaginal mesh implants on the market, patients are now undergoing alternative procedures to correct the problems mesh was supposed to solve.
“Surgeons are still performing surgeries without mesh, such as those that use sutures or native tissue, to repair stress incontinence and prolapse issues. Also, mesh repairs are still being performed abdominally,” says Llamas. “This means mesh is inserted through incisions made in the abdomen to hold up sagging organs instead of through the vagina like they are in transvaginal mesh surgery.”