One Bard Vaginal Mesh Trial Down – Thousands More to Go

Jul 24th, 2012 | By | Category: FDA

Bard Trial Set to Begin February 2013

U.S. District Court, Charleston, West Virginia

Friday’s $5.5 million verdict against C.R. Bard over its transvaginal mesh, the Avaulta Plus Biosynthetic Support System, was the first of more than one-thousand lawsuits facing the company with the first one scheduled in federal court February 5, 2013. (Background story here).

Christine Scott’s favorable verdict was heard in Kern County Superior Court in Bakersfield, California. See background story here.

Both sides will be looking at whether the Scott outcome is an indicator of future cases.

The first bellwether trial to be heard in February tests legal theories and the results can encourage an early settlement either way.

The bellwether cases are part of the thousands of consolidated cases moved to the Southern District of West Virginia which name four mesh manufacturers including American Medical Systems, Johnson & Johnson and Boston Scientific.

As of today, July 24, there are 1,014 cases filed against Bard consolidated in that Charleston, West Virginia courtroom before The Honorable Judge Joseph R. Goodwin of Charleston, West Virginia.

Consolidating cases into multidistrict litigation  occurs when there are common questions of fact. The federal court can coordinate the proceedings both pretrial and during trial, allowing for consistent rulings and a swifter, more cost-effective resolution.

The cases transferred to the C.R. Bard MDL (MDL No.2187) may have originally been filed in state and federal court around the country.

A list of the cases filed in the MDL can be seen here and the lawyers who are involved can be seen here.

C.R. Bard also makes the Avaulta BioSynthetic, Avaulta Plus and Avaulta Solo as well as pelvic repair meshes including PelviSoft, PelviLace, Palvitex, Uretex, Align, Acellular Collagen Matrix, Faslata Allograft, and Pelvicol.  

 

Will the FDA Follow Through on Safety Study Requests? 

Christine Scott

As in Christine Scott’s case, the women claim injuries from the synthetic polypropylene mesh such as mesh erosion and shrinkage, pelvic and nerve pain, organ perforation, and infection, among other complications. They allege Bard sold a defective and dangerous medical device and has been doing so since 2005.

Last January, the FDA ordered 33 mesh manufacturers to conduct a three year post-approval marketing studies to determine if mesh was causing injuries in women.  See the order here.

The companies were supposed to have their plans in place and begin the studies within 60 days, however the FDA website says “Study Pending.”

In the meantime, the Avaulta Plus System was removed from the U.S. market on July 1.   The FDA will issue a decision by August 4th whether or not it will still require the expensive, time consuming post-approval studies on the Bard products or the four vaginal meshes that Johnson & Johnson announced last month it would remove from marketing over the next 120 days. Background story here.

Many MDND readers indicated they would like to encourage the FDA to order the safety studies. (background story here).

C.R. Bard spokesman, Scott Lowry had not responded to questions posed by MDND by publishing time asking for some information on the Scott verdict. #

Learn More:

Will the FDA Grant J & J’s Request to Stop the Studies?
http://meshmedicaldevicenewsdesk.com/your-questions-asked-and-answered/will-the-fda-grant-jjs-request-to-stop-the-studies/

Steering Committee for C.R. Bard MDL
http://www.wvsd.uscourts.gov/MDL/2187/pdfs/2187Steering%20Committee,%20Lead%20and%20Liaison%20Counsel.pdf

C.R. Bard Court orders to date, U.S. District Court, Charleston West Virginia
http://www.wvsd.uscourts.gov/MDL/2187/orders.html

MDL 2187 list of plaintiffs July 24, 2012 ( 1,014 total cases as of July 24)
http://www.wvsd.uscourts.gov/MDL/avaulta/cases/recordList.cfm

Q and A about an MDL
http://www.wvsd.uscourts.gov/MDL/2187/faq.html

 

 

 

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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.