[author: Michele Bowman]
A California couple has been awarded $5.5 million in a lawsuit against the medical device manufacturer C.R. Bard Inc., makers of the vaginal mesh implant that caused plaintiff Christine Scott to develop incontinence, chronic pain and sexual dysfunction.
Many women suffering from maladies including leaky bladders and uterine prolapse who underwent implants of vaginal mesh devices found that their situations went from bad to worse. But now there might be at least some legal relief in sight.
The jury award marks the first successful suit against a maker of the mesh device; hundreds of women have brought suits against manufacturers of vaginal mesh products, claiming the devices are not tested properly and are defective.
Growing Problem with the Devices
In fact, the Food and Drug Administration last summer documented its “increasing concerns about adverse events associated with the transvaginal placement of mesh,” and subsequently found that vaginal mesh products pose a high risk of side effects. Women’s groups began demanding recalls.
Then in January 2012, the FDA ordered 33 manufacturers of vaginal mesh devices to study the safety of the products. Lawmakers are even getting involved; a U.S. representative from Massachusetts in March introduced a bill aimed at the mesh products, H.R. 3847, that would allow the FDA to require proof that the design of a new device based on an old one that has known safety issues has eliminated the dangers.
Manufacturers of the device had likely already seen the writing on the wall, but it may have been too late. According to one news report, a lawyer for Bard says the company stopped U.S. sales of the Avaulta Mesh device – the one the Scotts sued over – on July 1, 2012 because the FDA was demanding more clinical trials.
Johnson & Johnson also announced this summer that it would stop selling four lines of vaginal mesh devices. That was right before a New Jersey woman sued J&J and its subsidiary Ethicon over an implant gone bad.
Scott Breaks Silence
In the Scotts’ case, Christine was awarded $5 million and her husband $500,000 for medical expenses, pain and suffering, and more. The jury found that the device had ruined their love life and brought Christine’s activity as a runner to a halt.
Happy about the verdict, Christine was quoted as saying she is also relieved that a court-ordered silence has been lifted and she can now tell other women about the dangers of the product. “[W]hen I got that verdict it was like ‘Thank you, God.’ Now we can do something,” she said.
The verdict will likely be appealed and is being closely watched, especially given the massive multidistrict litigation going on in West Virginia over similar products. “We are pleased the Plaintiff prevailed in the California action and look forward to the first New Jersey trial in April,” said Bernstein Liebhard LLP partner Jeffrey S. Grand, a lawyer involved in the New Jersey case as well as the West Virginia MDL.
Six hundred cases have been consolidated in the West Virginia MDL trial against Bard, J&J, Boston Scientific Corp., and Endo Pharmaceutical Holdings Inc.’s American Medical Systems unit. Another MDL case is located in Georgia, and according to Jane Akre of the Mesh Medical Device News Desk, a sixth is being considered against Mentor Corp.
If you are concerned about the safety of a medical device, read more about your legal remedies and find an attorney in your area who can answer your questions.