C.R. Bard’s Pelvic Mesh Removed From the Market

Mesh Medical Device News Desk, June 13, 2017 ~ Bard relieves its website of all pelvic mesh products with no fanfare or notice.

In April, it was announced that C.R. Bard, a medical device manufacturer, was to be sold to Becton Dickinson (BD) for $24 billion.

In what could be surmised to be a house cleaning move, Bard appears to have cleared all of its pelvic meshes from its inventory.

At one time, medical device maker, C.R. Bard of Murray Hill, New Jersey, had a dozen or so transvaginal pelvic mesh devices on the market.

From its Covington, Georgia plant Bard made:

Bard Avaulta mesh

Avaulta Plus™ BioSynthetic Support System for POP ( Pelvic organ prolapse)

Avaulta Solo™ Synthetic Support System for POP

Faslata® Allograft - human graft tissue

Pelvicol® Tissue for SUI (stress urinary incontinence)

PelviSoft® Biomesh for SUI

Pelvitex™ Polypropylene Mesh for SUI

Today, they are all gone from the website.

The last day Bard could sell all of its SUI products was December 31, 2016, but according to the company, hospitals and facilities may use up any products remaining on the shelf.
The reason given was “economic.”

With more than 15,000 product liability cases pending against Bard consolidated in multidistrict litigation (MDL) in federal court in West Virginia, and nearly 1,000 cases pending against Bard in multidistrict litigation in New Jersey, economic reason is as good an excuse as any.

Not only does the company website have no mention of products under the Women’s Health category, but the revelation that Align was taken off the market was uncovered during a recent case management conference.

“They stopped selling all Align products in the summer of 2016,” trial attorney Adam Slater told Mesh News Desk, who adds that he has discovery on that issue as he prepares to take Bard to trial over its pelvic mesh implants.

See a MND story here.

In terms of mesh, the company continues to sell hernia mesh through its Bard Davol division.

Two requests for comment from the Bard company headquarters went unanswered.

The removal of products may not have a substantial impact on current mesh product liability litigation.

IS IT A SOFT RECALL?

This isn’t the first time the company has quietly removed problematic meshes from the market.

Bard stopped selling Avaulta Plus, used to treat pelvic floor prolapse, in July 2012, around the same time it lost a product liability case against plaintiff, Christine Scott, who was eventually awarded $3.6 million by a Bakersfield, California jury. The Scott case was the first transvaginal mesh case to go to trial.

The U.S. Food and Drug Administration (FDA) has received a number of adverse event reports on Bard Avaulta. See one here.

Last week, the federal court entered an order to create the Fleming, Nolen & Jez Bard Qualified Settlement Fund, the Wagstafff & Cartmell Qualified Settlement Fund and last month the Aylstock, Witkin, Kreis & Overholtz Qualified Settlement Fund.

Bard is one of six manufacturers with claims gathered in Charleston, West Virginia where there are more than 102,000 pelvic mesh trials consolidated and pending. The first Bard trial in this federal MDL was the bellwether case by Plaintiff Donna Cisson, who was awarded $2 million by a jury in 2013.

In August 2015, Bard agreed to settle 3,000 mesh cases for $200 million. In 2014, Bard agreed to a $21 million settlement to resolve 500 defective product lawsuits.

According to its 10-K SEC report, so far Bard has agreed in principle to settle about 11,000 claims including 560 in 2014; 6,285 in 2015; and 4,155 in 2016. These number include unfiled and previously unknown claims held by various plaintiffs’ law firms.

The company anticipates additional transvaginal mesh trials over the next 12 months, which may include consolidated trials.

Since early 2013, Bard has received subpoenas from a number of State Attorneys General seeking information related to the sale and marketing of certain products such as hernia and women’s health that are being litigated. (p. 19, SEC report). These matters are pending. There can be no assurance that a resolution will be reached or what the terms of any such resolution may be.

HERNIA MESH

Bard’s 10-K form says As of December 31, 2016 approximately 25 federal and 65 state lawsuits involving individual claims by approximately 90 plaintiffs, as well as one putative class action in the United States are currently pending against the company regarding Composix Kugel and certain other hernia repair products.

The company voluntarily recalled certain sizes and lots of the Composix Kugel products beginning in December 2005.

In June 2000, the Composix Kugel lawsuits were transferred to an MDL in US District Court for the District of Rhode Island. That court stopped accepting new cases in the second quarter of 2014 and it was terminated in November 2016. ###