Hernia Mesh Lawsuits over Atrium Medical C-Qur
Atrium Medical is being sued over its C-Qur (pronounced “secure”) hernia mesh. The U.S. Judicial Panel on Multidistrict Litigation (JPML), who decides whether to consolidate cases into a multidistrict litigation (MDL), will hear Oral Arguments regarding the litigation on Dec. 1 in Charlotte, North Carolina, court records show. Plaintiffs filed a motion to transfer these claims to the U.S. District Court, District of New Hampshire on Oct. 10.
MDLs are a type of mass tort where many lawsuits with the same allegations are transferred to one court before one judge. The JPML creates this type of group litigation in order to speed up the legal process for complex cases. Gathering cases together in one court eliminates duplicate discovery and streamlines proceedings. In this case, lawsuits allege that the C-Qur caused injuries and Atrium Medical failed to disclose the risks. Court documents show that at least 15 such lawsuits have been filed.
Alleged injuries associated with the C-Qur include infection, rejection, organ perforation, inflammation, chronic pain, additional surgery, rash, neurological changes, dental problems, bowel obstruction and abnormal liver function.
Roughly 1,500 C-Qur Edge mesh devices were recalled in August 2012 because the Omega-3 fatty acid coating on the mesh could adhere to the inner packaging liner due to high humidity. Atrium notified physicians of the issue and instructed them to inspect the mesh before implanting it in patients. However, the company did not pull the product from the shelves. The U.S. Food and Drug Administration (FDA) designated the recall as Class II, meaning it is a situation where the recalled product can cause temporary or medically reversible adverse events, or the probability of serious adverse events is remote.
The C-Qur was introduced in 2006. Plaintiffs allege that the mesh was cleared through 510(k), which allows devices to be approved without clinical testing so long as they are deemed “substantially equivalent” to a previously approved device. Unlike products that are cleared through premarket approval (PMA), manufacturers do not have to submit clinical data to prove their products are safe and effective. 510(k) has come under scrutiny in light of safety concerns with certain medical devices, including transvaginal mesh and metal-on-metal hip implants.
Transvaginal Mesh Litigation
Parker Waichman comments that Ethicon has also faced litigation over other mesh products, specifically transvaginal mesh implants used for pelvic organ prolapse and stress urinary incontinence. Thousands of women sued Ethicon and other pelvic mesh manufacturers alleging that the devices are defectively designed and led to injuries, including mesh erosion where the mesh goes through the vaginal tissues and damages other organs.
Women have filed lawsuits over the Ethicon Gynecare TVT, Prolift and other transvaginal mesh products. In January, the company agreed to pay $120 million to settle 2,000 to 3,000 lawsuits. The company is still facing an additional 42,000 vaginal mesh lawsuits. The largest number of transvaginal mesh products are filed against J&J, court documents show.
The J&J vaginal mesh litigation has resulted in some verdicts. In September 2014, jurors awarded $3.27 million to the plaintiff. Verdicts of $11 million and $1.2 million were handed down in 2013 and 2014, respectively.
Transvaginal mesh lawsuits have also been filed against C.R. Bard, American Medical Systems, Boston Scientific and Coloplast.
The FDA has warned that transvaginal mesh complications are “not rare”. The agency said in 2008 that the most common injuries associated with transvaginal mesh include:
• Mesh erosion
• Urinary problems
• Recurrence of prolapse
There have also been reports perforation in the bowels, bladder and blood vessels.
Filing a Hernia Mesh or Transvaginal Mesh Lawsuit
If you or someone you know suffered injuries related to the use of a hernia mesh or a transvaginal mesh product, you may have valuable legal rights. Our personal injury lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOUR-LAWYER (1-800-968-7529).
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