Product News and Recalls

Bard IVC Filter Plaintiffs to Seek Information on Safety Violations

As noted in the recent MDL transfer order, plaintiffs in Bard inferior vena cava (IVC) filter lawsuits are planning to seek more information about safety violations identified at two Bard facilities. Bard IVC filter plaintiffs hope the streamlined multidistrict litigation discovery process will aid in them getting information about these violations.

Bard is the country’s foremost producer of retrievable IVC filters—small, cage-like devices that are implanted into the vena cava to catch blood clots before they reach the heart or lungs. The filters supposedly reduce the risk of stroke and other life-threatening events. But recent evidence suggests that IVC filters may defective. In 2010, the FDA issued a safety communication warning of the long-term risks of retrievable IVC filters. The agency has urged practitioners to remove patients’ IVC filters as soon as possible to reduce risk of harmful side effects. These side effects, as indicated in 921 adverse event reports submitted between 2005 and 2010, include filter fracture, device migration, and vena cava perforation. Incidents like these can cause pieces of the IVC filter or the entire device to become lodged in vital organs, sometimes resulting in death.

For now, plaintiffs in the Bard IVC filter multidistrict litigation are focused on reopening discovery to seek information on safety violations committed at two of Bard’s facilities. The violations, outlined in a July 13 letter from the U.S. Food and Drug Administration (FDA), include failure to submit medical device reports, failure to adequately evaluate product complaints, and misbranding. At Bard’s Queensbury, New York branch, FDA inspectors took issue with violations in the cleaning processes for certain IVC filters; and at Bard’s Tempe, Arizona facility, the FDA found instances where Bard allegedly mishandled medical device reporting. In one case, Bard filed an IVC filter–related report under “device malfunction,” when in fact it should also have been filed under “deaths,” as it concerned a fatality.