FDA Issues Several Warnings After Inspection Of Bard IVC Filter Facilities
Medical devices are used every day to save lives, but a malfunctioning device often does more harm than good. In order to ensure patient safety, the U.S. Food and Drug Administration (FDA) conducts regular inspections of manufacturing and distribution centers for its approved medical products—an action that uncovered serious violations with Bard’s retrievable inferior vena cava (IVC) filters.
FDA Issues a Warning to Bard for IVC Filter Violations
In addition to recommending that retrievable IVC filters be removed from post-surgical patients as soon as possible, the FDA issued a warning to C.R. Bard Inc., threatening regulatory action due to failure of the company’s devices. In a letter dated July 13, 2015, inspectors reported several violations of FDA standards in Bard facilities in New York and Arizona. The company was advised to “immediately cease activities” that violated standard practices of approved medical devices, including:
- Adulteration of the Recovery Cone Removal System, Model RC-15. Inspectors discovered this model of the Recovery Cone System did not have an approved application for premarket approval, nor was it given an exemption as an “investigational” device. Also, since these devices are classified as specialized surgical instruments, they require marketing clearance to be sold in the United States, which was never granted by the FDA.
- Misbranding of the Recovery Cone Removal System, Model FBRC. The FDA claims this model of IVC device was never granted premarket approval or exemption, and is also considered “misbranded” because it was sold only after it underwent major changes in its approved use.
- Unhealthy contaminant levels. The IVC filter devices must be cleaned after manufacturing to remove to any chemicals left over from processing. Inspectors reported that cleaning procedures for many of Bard’s devices have not been shown to remove harmful contaminants, such as methanol, glycolic acid, and hydrofluoric acid.
- Reporting violations. Inspectors found that not only were the devices produced in violation of FDA standards, but also the company was guilty of several quality control conditions. The company was cited for its failure to have proper procedures to receive and evaluate device complaints; failure to properly investigate complaints; and failure to report complaints and failures adequately.
- Misbranding of the IVC Denali Filter Delivery System. One of the most worrying violations involved problems with Bard’s IVC Denali Filter Delivery System, including the claim that Bard “failed or refused” to furnish the FDA with information regarding known device failures. Makers of FDA-approved products are required to notify the agency of any malfunction in the product that results in serious injury or death within 30 days of receiving the information. According to the FDA, Bard failed to send these reports; failed to send complete information regarding complaints and malfunctions; and also failed to provide an action plan to obtain the missing information regarding the Denali system.
The FDA included a list of potential penalties for Bard if the company failed to address and correct the violations on its facilities, including seizure of products and company records; injunction to prevent further distribution; and civil fines. The company was also advised that federal agencies can be alerted to the presence of FDA warning letters, making the company’s violations public knowledge. Not only does this affect the company’s professional reputation and potential profits, it also can provide evidence for litigators and victims to collect higher settlements in court cases.
If You’ve Suffered from an IVC Filter, Let Us Help
This investigation is only the tip of the iceberg when it comes to the dangers of Bard IVC filters. Many patients have suffered device breakage, unnecessary surgeries, and life-altering injuries due to this device. The McGartland Law Firm has recovered millions of dollars in damages for people who were injured by defective medical devices, and we don’t collect any legal fees unless we win your case. Call the number on this page today or use our convenient contact form to speak with one of our representatives.