Bard IVC Filter Safety Problems

In 2015, NBC Nightly News aired a series of stories on their investigation into the Recovery filter. The news network reported that when Bard became aware of deaths and injuries linked to the filter it hired one of the top public relations firms in the world, Hill and Knowlton Strategies, to develop a crisis management plan. Bard also hired an independent consultant, Dr. John Lehmann, to prepare a confidential report comparing the Recovery filter to other IVC filters currently on the market.

Lehmann based his research on a database maintained by the FDA known as The Manufacturer and User Facility Device Experience Database (MAUDE). Manufacturers and facilities that use medical devices, such as hospitals and health clinics, are required to send reports to the FDA regarding any serious adverse event, including deaths, injuries and malfunctions connected to a medical device. Those reports make up the MAUDE database. Lehmann compiled a list of IVC filter adverse event reports in the database that had been filed between January, 2000 and September, 2004. He sorted these events by the type of filter complication (e.g., death, filter fracture and/or inferior vena cava perforation) along with the filter brand, including the Bard’s Recovery and Simon Nitinol filters. He also gathered sales data for each of the filters. He then compared the number of adverse events reported for a particular filter with the number of sales of that filter. This allowed him to determine, for each filter brand, how many adverse events had been reported per 100,000 filters sold.

The Recovery had the worst reporting rate in three of the seven categories of adverse events (deaths, filter movement and embolization deaths. (Embolization is the movement of the filter or a fractured filter part through the IVC to the heart or lungs). The Recovery was second worst in the remaining four categories.

Compared to the reporting for all other filters combined, the Recovery was:

• 3 times more likely to have a MAUDE report mentioning patient death.
• 6 times more likely to have a report of a filter fracture.
• 8 times more likely to have a report of IVC penetration.
• 3 times more likely to have a report of filter embolization.

The Simon Nitinol is another Bard IVC filter that came on the market in 1990. It appears to have performed better in this analysis than the Recovery filter that followed it.

Bard Reacts to the Lehmann Report

The NBC Nightly News broadcasts revealed that Bard continued selling the Recovery filter in spite of Lehmann’s report until the device was replaced with a new filter, the G2, in 2005, three years after selling the Recovery filter. The G2 was soon found to have many of the same problems as the Recovery.

According to NBC, confidential Bard records show the company was concerned about failures of the G2 filters just months before they were cleared by the FDA. A 2012 study that investigated the Recovery, G2, and G2 Express IVC filters reported an overall fracture rate of 12% and an embolization rate of fractured filter components of 13%. The success rate for removal of fractured parts was only 53.4%.

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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.”

If you or someone you know has been injured by a Bard IVC filter, please contact the IVC filter lawsuit team at Wisner Baum for a free case evaluation.