Dozens of patients with lawsuits against C.R. Bard Inc. (NYSE:BCR) asked to join a multi-district federal case against the company for allegedly selling defective and dangerous products – its Avaulta transvaginal mesh.
In one of the most recent suits, Lois Houghton wants a jury to decide whether Bard was negligent in designing the product and whether it failed to warn patients and doctors of potential risks.
The multi-district litigation, consolidated from 21 individual lawsuits in October 2010, includes complaints from women implanted with three different types of Bard mesh: The Avaulta Biosynthetic, the Avaulta Plus and the Avaulta Solo mesh. Earlier this month 29 other patients who filed suits regarding other Bard mesh products (Pelvicol, PelviLace, PelviSoft, Pelvitex, Uretex or Align mesh) asked to join the multidistrict litigaion.
The complaints arose as transvaginal mesh gained visibility in the public eye over FDA concerns that it might do more harm than good.
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The devices are used to treat pelvic organ prolapse, which occurs when internal support structures become so weak or stretched that organs, like the uterus, bladder or bowels, sag from their normal position and bulge or prolapse into the vagina.
"There are clear risks associated with the transvaginal placement of mesh to treat POP," said Dr. William Maisel, deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health, in an agency release in July, updating 2008 warnings that addressed concerns about adverse events associated with the transvaginal placement of the mesh. "The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant – complete removal may not be possible and may not result in complete resolution of complications."
From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for POP repair, five times as many as the agency received from 2005 to 2007, according to the release.
FDA panel meetings this month appeared to lean toward reclassifying transvaginal mesh products as Class III, the highest-risk category for medical devices, without recalling existing products.
Fellow mesh makers, including Johnson & Johnson (NYSE:JNJ) and Endo Pharmaceuticals Holdings Inc. (NSDQ:ENDP) agreed that more safety studies and labeling changes could help warn of potential risks and proposed that new applications for transvaginal mesh products require clinical testing.
Meeting conclusions have yet to be issued, but the panel appeared to lean heavily toward requiring new devices applications to undergo clinical testing while allowing existing products to stay on the market, AboutLawsuits.com reported.
Meanwhile, patient complaints are growing.
Johnson & Johnson and Bard and are the target of nearly 500 lawsuits filed by patients claiming the meshes caused internal injuries.
Last month Boston Scientific Corp. and American Medical Systems Holdings Inc. (NSDQ:AMMD) found themselves at the center of a lawsuit claiming that transvaginal mesh products sold by the companies were defective and caused severe injuries to a patient.
Bard’s new federal litigation comes on the heels of a $185 million settlement the company paid in the second quarter for lawsuits concerning its hernia repair products. The fines swallowed the company’s bottom line and pushed it into the red for Q2 2010.