Source: https://www.baumhedlundlaw.com/defective-medical-device-injuries/ivc-filter-lawsuit/fda-ivc-filter-warning-letter-bard/
Timestamp: 2019-02-23 11:35:29
Document Index: 514586664

Matched Legal Cases: ['art 803', 'art 820', 'art 803', 'art 820', 'art 803', 'art 820']

FDA Sends Bard an IVC Filter Warning Letter on Safety Issues
FDA Sends IVC Filter Warning Letter to Bard Baum Hedlund 2018-11-15T14:17:45+00:00
In July 2015, the U.S. Food and Drug Administration (FDA) sent a warning letter to IVC filter maker C. R. Bard, informing the company that it had violated several federal laws and regulations related to medical devices. The IVC filter warning letter specifically cited violations of the Federal Food, Drug, and Cosmetic Act (FDCA) and the United States Code of Federal Regulations (CFR). The CFR contains the rules and regulations established by executive departments (e.g., State Department, Department of the Treasury) and federal agencies, including the FDA.
The IVC filter warning letter came after FDA inspectors visited Bard facilities in Tempe, Arizona and Queensbury, New York. It warned Bard that failure to promptly correct the violations could result in seizures, injunctions and monetary penalties.
Perhaps the most important part of the letter, for Bard IVC filter users, concerned FDA charges that the company was in violation of regulations contained in two key sections of the CFR that govern the reporting of deaths, serious injuries and malfunctions related to medical devices and the overall safety of medical devices.
The Code of Federal Regulations (CFR), Title 21
The CFR is divided into large sections called “titles,” which are composed of smaller sections called “parts.” Title 21 of the CFR covers the rules of the FDA, the agency that oversees the manufacture and safety of drugs and medical devices. Much of the IVC filter warning letter is devoted to violations of two parts of Title 21, Part 803 and Part 820.
Part 803 of Title 21 deals with requirements related to reports (called Medical Device Reports, or MRDs) that must be made to the FDA when a medical device causes a serious adverse effect. Part 820 of this Title addresses Quality System Regulation, requirements that are intended to ensure that products are safe and effective. This Part includes both quality control measures during the manufacturing process and the proper handling of complaints regarding a device.
These two parts are closely related. Improper investigation of a complaint could lead to an incomplete or false MDR filed with the FDA—and this is exactly what the IVC filter warning letter charged.
IVC Filter Warning Letter: Bard Failed to Properly Investigate Complaints
The IVC filter warning letter charges Bard with violating CFR section 820.198(a), which requires manufacturers to establish reliable procedures for receiving, reviewing and evaluating complaints. The Arizona and New York facilities were both found in violation of this regulation.
As evidence for this failure, the FDA IVC filter warning letter cites several MDRs that were incorrectly filed with the agency. A brief explanation of the MRD reporting system may help to explain this violation.
Medical device reporting regulations (Part 803) require device manufacturers to report to the FDA whenever they learn that one of their devices may have caused or contributed to a death or serious injury. Serious injury is defined as an injury that is life-threatening, permanently impairs a body function or damages a body structure, or necessitates medical or surgical intervention to prevent permanent impairment or damage. Manufacturers are also required to report device malfunctions that would be “likely to cause or contribute to a death or serious injury” if they reoccurred.
As noted earlier, these reports are called Medical Device Reports. They are kept in a searchable database, known as the MAUDE (Manufacturer and User Facility Device Experience) Database. In their MDRs, manufacturers identify each adverse event according to its “event type,” a death, an injury or a malfunction.
Visit our IVC Filter Complications page for a full discussion of IVC filter complications and the database.
The FDA IVC filter warning letter accuses Bard of misreporting the event type in their MDR reports. Specifically, they accuse Bard of filing one report as a malfunction, when it should have been filed as a death. The FDA also accuses Bard of filing several reports that should have been identified as serious injuries, as malfunctions.
For example, in one case, one of the arms of a G2 Bard IVC filter (the arms hold the filter in place in the inferior vena cava) detached and travelled to the patient’s right lung. (The movement of an object or other mass through a blood vessel is referred to as an embolization. Embolization of IVC filter parts via the inferior vena cava to the heart or lungs is a major problem with IVC filters, including several Bard IVC filter models.) In this case, the embolization produced areas of hemorrhage and necrosis (the death of organ cells) in the lung. Though the patient died, the complaint was filed as a malfunction Medical Device Report (MDR).
“Complaint (b)(4) [(b) (4) indicates confidential information has been redacted] for a G2 Filter, embolization of a detached filter arm with associated areas of hemorrhage and necrosis in the right lung was filed as a malfunction Medical Device Report [MDR] and should have been filed as a death.”
July 13, 2015 IVC Filter Warning Letter from U.S. Food and Drug Administration to C. R. Bard, Inc.
In another case, a filter limb detached from an Eclipse filter. According to the letter, this resulted in pericardial effusion and the need for cardiac catheterization. The pericardium is a fluid-filled “sack” that surrounds the heart. In medicine, the word effusion refers to the escape of fluid into a space in the body. Pericardial effusion is a condition in which there is too much fluid in the pericardium. In severe cases, this can prevent the heart from functioning properly and become life-threatening—a condition known as cardiac tamponade.
The IVC filter warning letter does not give specifics of this case, but there have been numerous reports of pericardial effusion and cardiac tamponade resulting from fractured filter parts traveling to the heart and puncturing the heart wall. That may well be what happened in this case. A 2010 study of 189 patients published in JAMA Internal Medicine found that the fracture and embolization of filter fragments was high in two Bard IVC filter models, the Recovery and the G2. The hospital where the study was conducted halted further implantation of the two devices.
The IVC filter warning letter goes on to list several other cases in which the Bard filters produced what the FDA letter calls “serious injuries.”
A G2 Express IVC filter broke, requiring surgical intervention.
An arm of a Denali IVC filter embedded in the wall of the inferior vena cava.
The detached limb of a G2 filter was found in the “renal vein with IVC perforation.” There are two renal veins that carry blood purified by the kidneys into the inferior vena cava. IVC filters are usually implanted in the inferior vena cava just below the renal veins. Perforation of the inferior vena cava wall by the filter legs is a frequent adverse effect of IVC filters and can result in damage to the renal veins.
Three other instances of a Bard IVC filter (one G2 Express and G2 filters) perforating the inferior vena cava. In one case, the perforation was associated with an aneurysm and in the other two with abdominal pain.
The IVC filter warning letter states that in each of these cases, the Medical Device Report filed by Bard identified the complaint as a device malfunction, though they all appear to meet the FDA definition of serious injury and, according to the letter, should have been reported as such.
The letter also points to 10 patients who had unsuccessful surgery to remove an IVC filter. Bard’s complaint files, however, did not include information regarding prolonged or repeated surgery or possible complications resulting from the failed attempts at removal. The lack of this information, the FDA said, prevented adequate complaint investigation and a determination of whether or not an MDR needed to be filed.
“Your current procedures governing complaint investigation activities at your facilities … do not ensure product complaints are adequately evaluated.”
The false reporting of filter incidents and the failure to fully document complaints are, in the view of the FDA, significant problems demonstrating that Bard is not adequately investigating complaints about their filters.
Bard Fails to File MDR Reports
The IVC filter warning letter also refers to specific MDR violations at the Tempe, Arizona facility. Specifically the FDA charges that Bard failed to submit MDR reports for several complaints related to a malfunction of one of Bards IVC filters. The IVC filter warning letter also states that Bard failed to submit to the FDA information that was incomplete or missing from reports that had been submitted by user facilities (e.g., hospitals, clinics) who had filed MDR reports. (User facilities are also required to submit MDR reports both to the FDA and the manufacturer.)
Violations Related to Manufacturing
Title 21’s Quality System Regulations require that the processes involved in making medical devices like the IVC filter are subject to monitoring and controls to ensure that manufacturing requirements continue to be met (21 CFR 820.75[a]). The FDA IVC filter warning letter charged Bard with Part 820 violations related to the manufacture of IVC filters at Bard’s Queenbury, NY facility. The letter refers to the process of cleaning IVC filters to remove chemical contaminants used during the production of Bard’s Simon Nitinol, Eclipse and Denali IVC filters. The investigators found that the cleaning processes have not been verified to demonstrate that these contaminants are reduced to acceptable levels during routine processing.
The FDA also found Bard’s inspection and testing of its filters to be inadequate: “… your manufacturing process was not validated with a high degree of assurance and approved according to established procedures,” the FDA charged in its IVC filter warning letter.
Food and Drug Administration investigations help protect consumers from medical device manufacturers who fail to insure that their manufacturing practices and handling of complaints put public safety first. Another way to accomplish that same goal is by taking legal action. If you or a loved one has been harmed by a Bard IVC filter or other IVC filter brands, you are welcome to contact the IVC filter lawsuit team at Baum, Hedlund, Aristei & Goldman by filling out the contact form on our IVC Filter Lawsuit page or calling us at 1-800-827-0087. There is no charge for a consultation.