C.R. Bard (NYSE:BCR) ignored warnings that the plastic used in its transvaginal mesh implants was unfit for use in humans, according to court documents recently unsealed in personal injury lawsuits filed against the medical device company.
The manufacturer of the plastic used in Bard’s Avaulta mesh implant for hernia repair warned that it wasn’t suitable for implantation, according to the documents. Bard executives sought to conceal the use of the plastic from its manufacturer, a division of Chevron Phillips Chemical Co., according to the records.
"IMPORTANT … these suppliers will likely not be interested in a medical application due to product liability concerns," Roger Darois, a vice president of research at Bard subsidiary Davol, wrote in a 2004 email. "We purchase our polypropylene monofilament from an extrusion supplier who purchases the resin directly from the resin manufacturers. Thus, it is likely that they do not know of our implant application. Please do NOT mention Davol’s name in any discussions with these manufacturers. In fact, I would advise purchasing the resin through a 3rd party, not the resin supplier to avoid a supply issue once the medical application is discovered."
Bard is facing thousands of lawsuits over its pelvic mesh products, including a trial slated for July 8 in West Virginia that’s 1 of 4 bellwether cases for the multi-district litigation of the cases.
"During the upcoming trial, Bard will provide all the relevant evidence for the jury to consider and render a decision, which will demonstrate that Bard acted appropriately in its acquisition of polypropylene resin," Bard vice president Scott Lowry told Bloomberg via email. "We believe that the Avaulta polypropylene mesh implant is a safe and effective treatment for pelvic organ prolapse when used in accordance with its instructions."
But the Darois emails raise "a genuine issue of material fact about whether Bard was aware its conduct was practically certain to cause injuries," Judge Joseph Goodwin wrote, according to the documents.
Last week, another medical device company, Endo Health Solutions (NSDQ:ENDP) subsidiary American Medical Systems, agreed to pay $54 million to settle personal injury lawsuits filed over its pelvic mesh products.