A recent letter from the U.S. Food and Drug Administration (FDA) reveals that IVC maker C. R. Bard committed several quality system violations at its facilities in Queensbury, New York, and Tempe, Arizona. According to the FDA, Bard failed to “establish and maintain procedures for receiving, reviewing, and evaluating complaints as required by [law].” The agency cites several instances in which Bard’s quality system did not ensure adequate evaluation of complaints.
C. R. Bard is a leading manufacturer of inferior vena cava (IVC) filters—small, spider-shaped devices implanted in the body to catch potentially dangerous blood clots and reduce risk of stroke and other cardiovascular conditions. In 2010, the FDA released a safety communication about the risks of long-term IVC filter treatment. In its communication, the agency cited 921 adverse event reports describing various side effects of IVC filter use, such as fracturing of the implant, vena caval perforation, and whole device migration. Bookending the FDA’s report were studies revealing the high failure rates of retrievable IVC filters from companies like Bard and Cook Group. In response, dozens of patients have filed IVC filter lawsuits in an attempt to recover damages caused by failed IVC filters.
In its July 13 letter, the FDA found fault with several regulatory aspects of Bard’s quality system, including: Standards for Product Complaint Handling; Standards for Complaint Investigation Process; Complaint Investigation Activity; BPV Complaint Handling System; and Complaint Investigation Procedures. According to the FDA, certain areas of these quality system controls fail to ensure “that complaints involving a device or device component provided by a supplier are adequately evaluated for root cause of the alleged device failure and that appropriate corrective action is implemented with [Bard’s] suppliers.”
At Bard’s Queensbury, New York branch, FDA inspection turned up violations in the cleaning processes for certain IVC filters. The agency writes that these processes are not validated or otherwise proven to reduce potentially dangerous processing agents, such as nitric acid and methanol, to acceptable levels under routine conditions. Additionally, the FDA cited Bard’s failure “to establish and maintain procedures for acceptance of incoming product and to inspect, test or otherwise verify incoming product as conforming to specified requirements as required by [law]”; and “to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by [law].”
If you or someone close to you was injured by a failed IVC filter, contact Lopez McHugh today to speak free of charge with one of our experienced IVC filter lawyers. You may be eligible to receive compensation through an IVC filter lawsuit.