Latest Legal News - A Surge in Avaulta Claims May Consolidate

Jane Akre
October 13, 2011

U.S. District Court, Charleston, West Virginia

OCTOBER 13, 2011 - Hundreds of lawsuits against medical device maker, C.R. Bard, have been filed and the latest motion attempts to bring them into one mass case.

A Georgia law firm has filed a motion to bring 29 vaginal mesh lawsuits against C.R. Bard medical devices for pelvic repair into the Southern District federal court in West Virginia where other cases are pending as part of multidistrict litigation (MDL).

On September 15, Henry Garrard III of Blasingame, Burch, Garrard & Ashley, P.C. asked the U.S. Judicial Panel on Multidistrict Litigation to transfer 29 product liability lawsuits naming C.R. Bard. Inc as well as subsidiaries of the medical device maker, Covidien, to the U.S. District Court for the Southern District of West Virginia.

The cases to be consolidated are currently in three different federal district courts in Indiana, Georgia and Florida before 12 judges.

Bard Products

These complaints were filed by women who claim injury from other Bard surgical mesh products - Pelvicol, PelviSoft, Pelvitex, Uretex and or Align, or PelviLace products. These are slings permanently implanted in a woman to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI). Either C.R. Bard or its subsidiary Covidien sold or distributed the products.

The MDL cases, which were consolidated in West Virginia in October 2010, involved three other types of Bard mesh - the Avaulta Biosynthetic, Avaulta Plus and Avaulta Solo as well as non-Avaulta products. (MDL 2187)

Defective Design and Failure to Warn

The action alleges defective design and a failure to provide appropriate warnings about the risks associated with these medical devices which caused substantial injury to the women, according to the complaint.

On July 13, the U.S. Food and Drug Administration issued a notification that the risks of surgical mesh may outweigh the benefits and complications include infection, pain, bleeding, organ perforation and a return of the condition that could lead to additional surgeries. The agency said it had received more than 1,000 complaints of adverse reactions.

This request will expand the Avaulta Pelvic Support Systems Product Liability Litigation (MDL No. 2187) (court calendar here) by consolidating the cases due to their similar nature.

In a press release (here) Garrard says the cases are similar because they involve similar uses of the Bard Women’s Pelvic Repair products in the female anatomy and involve the same set of facts relating to Bard’s research, design, development, testing, manufacturing and distributing of the medical devices.

“Transferring and centralizing these cases is appropriate because coordination of the pretrial proceedings will promote the just and efficient conduct of the actions, as well as serve the convenience of the parties and the witnesses,” plaintiffs argued in the motion.

Safe and Effective

Bard reps told the FDA in September their mesh is safe and effective and injuries are rare.

More than 75,000 women receive surgical mesh every year to treat pelvic organ prolapse and incontinence. It never went through the FDA pre-market approval process yet is a permanently implanted medical device.

Garrard has represented plaintiffs who filed a product liability action against the Mentor Corp. over its OBTape Transobturator Sling Product in the U.S. District Court for the Middle District of Georgia (MDL No 2004).

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