C.R. Bard Vaginal Mesh Material Deemed Unfit for Humans

Jacky Gale | July 10th, 2013

Transvaginal Mesh ComplicationsC.R. Bard has been named as the defendant in thousands of vaginal mesh lawsuits for allegedly designing and manufacturing defective products, and now recently released court records reveal evidence that appears to substantiate plaintiffs’ claims.

The records appear to support the claim of defective design due to the inadequacy of the material, which had the potential to lead to severe transvaginal mesh complications.

E-mail reveals attempt to conceal

C.R. Bard received material for its mesh products from Chevron Phillips Chemical Co. Chevron Phillips issued precautions against using the mesh product, stating that it was not suitable for permanent implantation in human patients. Despite this, some plaintiffs claim that the allegedly substandard material was the same used in their mesh implants.

In e-mails dated from 2004 and 2007, Roger Darois, an executive at C.R. Bard’s Davol unit, requested that his colleagues avoid telling their suppliers that the mesh material was to be used in humans. He asked that the suppliers not be given the company’s name because Chevron Phillips and other suppliers “will likely not be interested in a medical application due to product-liability concerns… Please do not mention Davol’s name in any discussion with these manufacturers,” according to Darois’ e-mails.

A vice president of Bard, Scott Lowry, gave a statement that indicated confidence in Bard’s decision to use allegedly defective material. According to Lowry, “Bard acted appropriately in its acquisition of polypropylene resin,” which the defendants believe is a “safe and effective treatment for pelvic organ prolapse.” Lowry and other executives have declined to comment on Darois’ e-mails.

Plaintiffs allege transvaginal mesh complications

The mesh material in question is resin-based and made of polypropylene. It was used in Bard’s Avaulta transvaginal mesh products. Plaintiffs who have filed transvaginal mesh lawsuits allege significant complications, some of which required surgery and caused permanent  injuries. The mesh products are intended to support the pelvic organs. However, patients have frequently alleged side effects that are more damaging than the original condition.

Some of the alleged transvaginal mesh complications cited in litigation against Bard include perforation of the bowel, bladder, and blood vessels, infection, rejection of the mesh product, failure of the surgery, ongoing pain, and urinary incontinence. Mesh products have also been known to erode and extrude into the vagina. These plaintiffs seek compensatory damages for their medical expenses, ongoing care needs, and pain and suffering.

Upcoming bellwether trials

C.R. Bard faces thousands of lawsuits, many of which have been centralized into multidistrict litigation (MDL), which is currently proceeding in the U.S. District Court for the Southern District of West Virginia. The first bellwether trial for the MDL is already underway. Bellwether trials serve as initial trials in mass litigation for the purpose of gauging jury reactions and considering evidence.

In the first bellwether trial against C.R. Bard, the plaintiff, a 54-year-old woman, alleges that the defendants’ transvaginal mesh product caused her significant pain, bladder spasms, and bleeding. She required revision surgeries because of the complications. Her lawyers allege that the defendants failed to adequately warn her of the risks of the Avaulta line, and that the mesh product itself was defective in design. Following this trial, Bard faces three additional bellwether trials with plaintiffs who allege vaginal mesh erosion, organ damage, and other major transvaginal mesh complications.

Bloomberg, Bard Used Mesh Plastic Found Unfit for Humans by Supplier http://www.bloomberg.com/news/2013-06-26/bard-used-mesh-plastic-found-unfit-for-humans-by-supplier.html