Are You at Risk From Blood Clots in Your Veins?
Deep vein thrombosis is serious medical risk faced by many people who have…
- Knee or hip replacement surgery.
- A broken hip or leg.
- Cancer treatment.
- A history of blood clots.
- Spinal cord paralysis.
- Taken post-menopausal hormone replacement therapy.
- Varicose veins.
- Had a heart attack or congestive heart failure.
- Had a stroke.
- Inflammatory bowel disease.
It is also a risk faced during pregnancy and childbirth.
Deep vein thrombosis means that there is a blood clot somewhere deep in your body, typically in your leg. The risk is that the clot could break free from its spot and travel to your lungs, causing a pulmonary embolism and possibly death.
Sometimes blood thinners or other medications don’t work and doctors turn to other medical treatments to try to prevent a deadly pulmonary embolism. One of the other medical treatment options is an IVC filter.
What Is an IVC Filter?
IVC filters have been around for decades. They are metal cages that are inserted in the inferior vena cava (“IVC”)—a large vein that carries de-oxygenized blood from the lower part of the body to the lungs and heart. The metal cages are designed to catch any blood clots that break away from veins in the legs before they reach the lungs.
C.R. Bard Inc. (Bard) is one manufacturer of IVC filters. The Bard® Recovery™ filter, the Bard G2® filter, and the Bard G2X® Express filter were all approved by the federal Food and Drug Administration (FDA). However, the medical device company is no longer manufacturing or selling these models of IVC filters.
The Dangers Associated With IVC Filters
The problems associated with IVC filters include…
- Device migration: The filter moves or tilts in the body.
- Fracture: The filter breaks in the body.
- Embolization: The entire filter, or parts of it, moves to the heart or lungs.
- Perforation: The filter can cut the inferior vena cava.
- Extraction resistance: Difficulty removing the device, particularly when a complication has occurred.
These problems can result in:
- A blood clot getting by the IVC filter and causing a pulmonary embolism.
- Spearing or piercing the inferior vena cava, heart, or lungs.
- Blood vessel damage.
- Bleeding and bruising.
- Internal organ damage.
While many of these risks are associated with different brands of IVC filters, the Bard Recovery IVC filter was associated with a higher risk of death, filter fragment and filter movement when compared with other comparable devices. At least 27 deaths and 300 injuries have been reported.
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.
What the FDA Now Says About IVC Filters
In 2010, the FDA issued a safety communication about retrievable IVC filters. In that communication, the FDA indicated that it had received 921 adverse event reports related to IVC filters from 2005 to August 2010. It recommended that doctors remove retrievable IVC filters when a patient’s risk for pulmonary embolism is lowered. This advice was repeated again by the FDA in a 2014 safety communication.
Currently, lawsuits are pending against Bard and Cook Group, the manufacturers of the Bard® Recovery™ filter, the Bard G2® filter and the Bard G2X® Express filter. The lawsuits allege that the metal legs on these filters broke off and pierced the heart, blood vessels, or major organs and that the filters detached from the places where they were implanted and moved to other parts of the body.
Bard is accused of negligence, failure to warn, design defects, manufacturing defects, and other serious allegations. While many cases are still pending, one case settled in February 2015 after the plaintiff’s tear from his Bard® Recovery™ filter caused him to have open heart surgery and a lengthy recovery.
If you have suffered an injury from a Bard® Recovery™ filter, a Bard G2® filter, or a Bard G2X® Express filter—or if your loved one has died from complications from one of these IVC filters—then we encourage you to learn more about your rights. Call us today at 888-450-4456 to schedule a free consultation.