At least 27 deaths and about 300 non-fatal injuries have reportedly been caused by C.R. Bard’s IVC Recovery Filter. An IVC filter, such as Bard’s Recovery filter, is a metal device inserted into the inferior vena cava (IVC) that is designed to catch blood clots that break away from veins before they enter the lungs.
IVC filters are supposed to prevent deadly pulmonary embolisms, but device migration, fracture, and other complications can result in fatalities and serious injuries.
Did Bard Know About the Risks Prior to FDA Approval?
The Federal Drug Administration (FDA) initially rejected Bard’s application for FDA approval of the Recovery filter. After that, Bard hired a regulatory specialist to help the company get the device approved. That regulatory specialist, Kay Fuller, has told NBC News that she was “pretty concerned that there were going to be problems with this product.” She alleged that Bard failed to give her “important safety performance test results” and that the small clinical trial of this product raised “red flags.”
Ms. Fuller claims that when she raised her concerns, she was told that she would be removed from the team if she continued to pursue those issues. Still, she allegedly told Bard that she would not sign the FDA application for approval until the issues that she identified were resolved. Yet the application that was submitted to the FDA had the signature of Kay Fuller on it.
Was It Forged?
Ms. Fuller alleges that the signature on the FDA application is not hers. More specifically, she alleges that it was forged and that her name was on the application without her knowledge. She says that she told the FDA of her concerns and resigned from Bard before the application was submitted. Bard is denying Ms. Fuller’s claims and the FDA is saying that it takes any allegation of forgery seriously.
What Else Was Bard Hiding?
In 2004, Bard received the results of a confidential study that it commissioned. The results of the study, reported by an independent doctor, found that the relative risk of the Recovery filter was significantly higher than other permanent and retrievable filters on the market for:
- All adverse events.
- Filter fractures.
- Filter movement.
- Filter embolization deaths.
Additionally, the relative risk of the Recovery filter was significantly higher than other permanent filters on the market for:
- Caval perforation.
- Filter embolization.
The study’s author concluded that “further investigation of the Recovery VCF filter performance in relation to migration and fracture is urgently warranted.”
In 2005, Bard stopped selling the Recovery filter and started selling a modified version of the filter under a new name. However, it estimated that about 20,000 people still had Recovery filters implanted in 2006.
If you had an IVC filter implanted, then it is important to talk to your doctor about the possible side effects. Also, if you’ve been hurt or if your loved one has died due to a Bard IVC filter complication, then it is important to know more about your rights and your possible recovery. Please start a live chat with us now to learn more about how to protect your future.