Bard IVC Filter and the FDA’s 510(k) Clearance Process
How is it that the same issues associated with one Bard IVC filter appear to be passed on to the next model and then the next? One answer comes from the process by which the FDA approves medical devices.
Each Bard IVC filter has been cleared for marketing via the FDA’s 510(k) process. This process does not require clinical trials that test the safety and effectiveness of a device on human subjects—either before or after clearance. It only requires the maker to show that a device is “substantially equivalent” to a device that is already on the market, called the “predicate device.” If a device fails the 510(k) process, it must go through a premarket approval (PMA) process which is much more thorough and demanding and requires clinical trials. Devices that complete PMA requirements are called “approved medical devices.” Devices that go through the 510(k) process are said to be “cleared” devices.
The FDA’s 510(k) process appears to have led to the clearance of many medical devices that were later found to be dangerous and even deadly. A 2011 study in JAMA Internal Medicine, a journal published by the American Medical Association, found that from the year 2005 through 2009, 113 devices were recalled for being “life-threatening or very serious hazards,” Eighty (71%) were cleared through the 510(k) process.
The JAMA study applies directly to the 510(k) approval process that cleared every Bard IVC filter. In each case the predicate device used to gain clearance for a new Bard IVC filter—the device to which the filter was claimed to be substantially equivalent—was the previous Bard IVC filter. The Recovery was the predicate device for the G2, the G2 was the predicate device for the G2 Express and the G2 Express was the predicate device for the Eclipse. No clinical trials to test the safety and effectiveness of these devices were required. Each Bard IVC filter, including the Meridian and the Denali, was cleared based on an earlier Bard IVC filter.
It is easy to see how such an approval system could provide a gateway for design flaws to pass from one generation of Bard IVC filter to the next. A July 2011 report prepared for the FDA by the prestigious Institute of Medicine concluded, “510(k) clearance is not a determination that the cleared device is safe or effective.”
Recent Bard IVC Filter Designs: Eclipse, Meridian and Denali
Not surprisingly, the Eclipse filter, successor to the G2 and G2X and G2 Express filters, has also come under attack. On December 9, a lawsuit was filed by a Mississippi man who was implanted with an Eclipse filter. In his complaint he alleges that the filter tilted and at least five of the filter legs passed through the vein, with two legs abutting the abdominal aorta. The filter can no longer be removed. In another recent complaint, a Colorado man alleges that the Eclipse filter tilted and fractured, causing a piece to embolize to the right ventricle.
In January 2015, two doctors at the Stanford University Medical Center reported that a Denali filter fractured six months after being implanted in a 46-year old woman. The woman had complained of severe chest pain. The filter had fractured and one arm had traveled to the woman’s right ventricle. During open heart surgery the filter fragment was found to have penetrated the ventricular wall, causing cardiac tamponade, a condition in which the sac surrounding the heart fills with fluid. This puts pressure on the heart and prevents it from completely filling. This condition can be fatal. The doctors analyzed the filter fragment and found “metal fatigue indicating the filter design failed to withstand this patient’s natural inferior vena cava biomechanical motions.”
FDA Sends a Warning Letter to Bard for IVC Filters
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.
If you or someone you know has been injured by a Bard IVC filter, please contact the IVC filter lawsuit team at Wisner Baumfor a free case evaluation.
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