NBC: C.R. Bard Forged Documents on Controversial Blood Clot Filter to Gain FDA Approval

//NBC: C.R. Bard Forged Documents on Controversial Blood Clot Filter to Gain FDA Approval

NBC: C.R. Bard Forged Documents on Controversial Blood Clot Filter to Gain FDA Approval

recovery blood clot futureMND, September 8, 2015 ~ This week, NBC News investigated a blood clot filter made by C.R. Bard, and the questionable way the controversial medical device was approved for market. Bard also makes a number of pelvic meshes which are the focus of thousands of defective product lawsuits. 

The Recovery blood-clot filter, is associated with 27 deaths so far and other complications. It was cleared by the U.S. Food and Drug Administration in 2002.  See the story here.

After her car accident, Dodie Froehlich received the Recovery in the large vein in the body to block clots. Bard is one of 11 companies that makes these filters in the U.S. Instead a one-inch piece of metal from the Recovery pierced her heart.  She survived. Others did not.

Forged Documents? kay fuller signature

NBC unveils that a regulatory specialist, Kay Fuller did not sign the FDA application document in 2002, even though her name appears on the document.

After the Recovery was initially rejected by the FDA, Bard hired Fuller to try again.  Bard refused to give her the safety testing she requested.  She said she would not sign an FDA application until safety concerns were addressed. With no response to her request, Fuller resigned from Bard.  She talked to NBC News.

As of 2006 there are at least 20,000 patients walking around with a Recovery blood-clot filter in their body.

The Cissons enter court, August 2013

The Cissons enter court, Aaugust 2013

Bard and Cisson Trial

C.R. Bard was showed to have falsified documents in the pelvic mesh trial of Donna Cisson.  The raw material used to create the Avaulta mesh was a polypropylene (PP) resin in pellet form which was purchased from petroleum company Phillips Sumika.  The PP was spun into a monofilament which makes up the mesh of the Avaulta Plus.  Bard Marlex Mesh MSDS

A Material Data Safety Sheet from Chevron Phillips clearly stated the material should not be used in medical applications especially

“involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.”  

E-mails presented at trial by Cisson’s attorney, Henry Garrard, showed Bard created a dummy company, Red Oaks, to buy the polypropylene pellets so the supplier would not link Bard to the polypropylene purchase, therefore the creation of a medical device.   See MND coverage here.

Cisson was awarded $2 million by a Charleston, WV jury in August, 2013. Bard has appealed her case. See the MND coverage of her trial conclusion here. 

A year earlier in a Bakersfield, California court, Christine Scott was awarded $5.5 million by a jury over her pelvic mesh injuries.  Her  implanting physician was found to be responsible for a portion of the award for damages.

The Cisson case was the first bellwether against C.R. Bard in multidistrict litigation in Charleston, WV.  As of today, Bard is facing 12,521 product liability cases over its pelvic mesh as well as numerous other pelvic mesh actions filed in state courts around the country. #

 

By | 2015-09-09T01:49:31+00:00 September 9th, 2015|Media Reports|3 Comments

About the Author:

I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.

3 Comments

  1. msm September 9, 2015 at 6:46 am - Reply

    I wonder how many “Recovery” devices are still being implanted or have been implanted since the first death occurred. Suspending use pending further testing should be mandatory after a death directly related to a device or suspected to be related to a defect in the device. Other countries suspend the use pending investigation and further testing, but not the U.S. where profit is valued over life. Cynical, but my opinion nonetheless.

  2. kitty September 9, 2015 at 3:07 pm - Reply

    Is this “The Greenfield Filter?”

  3. Allison June 29, 2018 at 12:48 pm - Reply

    So whatever happened with this? It’s been 3 years, did anyone do prison time for this felony? Was DNA testing done on the paper to see if Kay Fuller ever even touched it? That can and should have been done! What did the FDA criminal investigation turn up? Did the FDA pursue felony charges or are they just as complicit in this as everyone in the world assumes they are?

Leave A Comment