An article written for The Legal Examiner brought light to the current transvaginal mesh legal process. A big court decision was issued yesterday by the U.S. Court of Appeals for the Fourth Circuit in Cisson v. C.R. Bard, Inc. As of late, more than 70,000 transvaginal mesh lawsuits have been filed against seven companies, making it “one of the biggest U.S. mass torts in history.” Due to how many claims have been made, all alleging similar violations, most of them have been consolidated in a large MDL suit filed in the U.S. District Court for the Southern District of West Virginia under Chief Judge Joseph R. Goodwin. However in yesterday’s decision, the Fourth Circuit affirmed the first jury verdict arising from multidistrict litigation which awarded the plaintiffs Donna Cission and her spouse Don $250,000 in compensatory damages and another $1,750,000 in punitive damages against device manufacturer C.R. Bard Inc.
Background on Transvaginal Mesh
Transvaginal mesh is a spider/net-like implant that is used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women. This device is usually made of polypropylene and is inserted through the vagina. Transvaginal mesh acts as a barrier for conditions that typically plague women after a hysterectomy, menopause or childbirth. These conditions force weakened pelvic muscles to no longer hold up the bladder, rectum and uterus, dropping these pelvic organs into the vagina.
While its purpose was to help women suffering from SUI and POP, not all of them are safe and reliable. Consequently, the design and manufacturer-recommended implantation technique of some of these transvaginal mesh products has contributed to serious complications such as infection, erosions of the vaginal tissues and organ perforation .
For these reasons, the decision for the couple is substantial news as it makes C.R. Bard responsible for their emotional and physical pain suffered from the transvaginal mesh. The ruling itself is also significant for a broader reason because it rejects a defense that could have created a disastrous situation for injury victims in a wide-range of cases—specifically defective medical device cases.
C.R. Bard’s Defense
One of the key arguments in Bard’s appeal was the fact that they complied with the U.S. Food and Drug Administration’s Section 510(k) medical-device process. According to the FDA website, “A 510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subjected to Premarket Approval. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims.” The description on the FDA’s site is what Bard capitalized on due to their compliance with the clearance. Since their product was considered safe by this process, then Bard argued that it should have been allowed to tell that fact to the jury.
For more support, the U.S. chamber of Commerce and other corporate groups argued that “evidence of 510(k) clearance is relevant under Georgia law and easily passes muster under Federal Rule of Evidence 401, as it bears on the safety, efficacy, and reasonableness of the product’s design.” They continued that, “the District Court erred in concluding that the 510 (k) process is not concerned with the device’s safety or effectiveness.”
However, in effect, the 501(k) process does not actually institute that a product may not be dangerous. Instead, the program merely establishes a device as “substantially equivalent” to another device. It’s doesn’t cover any safety issues or regulations nor does it impose any new requirements on devices. Due to this, Cisson won because Bard could not introduce evidence of the 501(k) compliance to prove its “reasonableness” under law. Thus, while other courts have used the evidence of compliance with the 510(k) as sufficient evidence, the Fourth Circuit believes that there is no evidentiary value in this claim. This is a huge win because if Bard’s argument succeeded, then mega device manufacturers could sue the same claim to prove their “reasonableness” under law .
Dolman Law Group
This decision by the Fourth Circuit is extremely important for the other thousands of cases still awaiting trial. Women who have to go through the emotional and physical trauma of a transvaginal mesh injury need to be advocated for as these manufacturing companies will use all tactics possible to avoid liability. Now that the 501(k) defense has been thrown out of one case, other courts may follow the same response. That’s why it’s important, more than ever, to come forward if you or a loved one have been a victim of transvaginal mesh surgery.
SUI and POP are conditions that are common for any women after childbirth, menopause or a hysterectomy. Transvaginal mesh was supposed to be the device that could help women with this uncomfortable and painful conditions but instead, for many, it made things much worse. Do not hesitate to get in touch with the experienced product liability and defective medical device attorneys of Dolman Law Group. If the medical organization or manufacturer that provided the surgery and subsequent device failed to adequately warn you of the serious dangers that arise from having transvaginal mesh implanted, you may be entitled to compensation.
Here at Dolman Law Group in New Port Richey, Florida, we have experience in dealing with companies that sell harmful or hazardous products. Consumers have rights and we strive to protect those rights. Contact us for a free consultation and case evaluation to learn your rights and options. Call (727) 853-6275.
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