Let the Trials Begin – C.R. Bard

May 7th, 2012 | By | Category: Legal News

Bard Avaulta from website

May 7, 2012 ~ The date has been set  – February 5, 2013 will be the  first of what promises to be a series of federal court trials over vaginal mesh injuries in women implanted with synthetic mesh made by C.R. Bard Inc.

Multidistrict litigation (MDL) No. 2187 is consolidated before U.S. District Judge Joseph R. Goodwin who is presiding over about 600 cases against Bard. The company makes Avaulta synthetic surgical mesh, Avaulta BioSynthetic, Avaulta Plus and Avaulta Solo as well as pelvic repair meshes including PelviSoft, PelviLace, Pelvitex, Uretex, Align, Acellular Collagen Matrix, Faslata Allograft, and Pelvicol.

In January, the cases filed around in country in federal courts were consolidated before Judge Goodwin in his Charleston, West Virginia courtroom. Hundreds of other cases have been filed in state courts around the country.

The early cases are called bellwether trials in that they establish the parameters of cases to follow when there are a large number of plaintiffs with similar issues. A bellwether trial allows a small group of plaintiffs to represent the group because they share similar issues to be heard before a jury.  The outcomes will indicate how future cases will be tried and may serve as the basis for a settlement.

The women claim injuries such as mesh erosion and shrinkage, pelvic and nerve pain, organ perforation, and infection, among other complications. The lawsuit accuses Bard of selling a defective and dangerous transvaginal mesh product which is intended to support long-lasting organ stabilization. The FDA has received over one-thousand reports of complications associated with Bard Avaulta since 2005.

There are three other mesh manufacturers named in the multidistrict litigation or MDL consolidated in the U.S. District Court for the Southern District of West Virginia. The three include American Medical Systems, Boston Scientific Corp. and Ethicon Inc. Bard has been in the same court since 2010.

Three attorneys were appointed by Judge Goodwin to lead the plaintiffs’ lawyers for all four MDLs. They include Bryan Aylstock, Fred Thompson III, and Henry G. Garrard III.

Judge Goodwin will preside over the discovery process and pre-trial motions for all four MDLs. Garrard has been involved in synthetic mesh litigation since 2006 when he was lead counsel in the Mentor Corp. Ob Tape Transobturator Sling heard in federal court in the Middle District of Georgia. The outcome resulted in a confidential settlement one week after the trial began. Since 2009, Garrard has been lead counsel for the Bard MDL.

State and federal cases could easily run into the thousands because about 75,000 women are implanted with synthetic surgical mesh to treat pelvic organ prolapse and stress urinary incontinence every year.

Synthetic vaginal mesh remains on the market though last fall an expert panel recommended it be reclassified as high-risk or Class III. A Food and Drug Administration report from last August recommended vaginal mesh products also be reclassified as high-risk because of the number of adverse reports coming forward to the agency. Consumer and women’s groups want the mesh recalled.

Just short of a recall, in January the FDA ordered mesh manufacturers to begin studying the rate of complications after implant surgery. The surveys must continue for three years.

Learn More:

Numbers of cases in US Courts:
http://www.jpml.uscourts.gov/Pending_MDL_Dockets-By_District-March-2012.pdf

Bloomberg on Bard cases set
http://www.bloomberg.com/news/2012-05-02/bard-faces-first-federal-trial-over-vaginal-mesh-next-year-1-.html

C.R. Bard on mesh placement- Animation
http://www.bardmedical.com/AVAULTASupportSystem

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One Comment to “Let the Trials Begin – C.R. Bard”

  1. [...] You can read the background on the Bard trial here:  Let the Trials Begin  [...]

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We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.