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