Bard IVC Filter Safety Problems

Bard IVC Filter Safety Problems

Bard IVC Filters Cause Serious Injuries in Patients

C.R. Bard, Inc. is a manufacturer and marketer of medical devices based in Murray Hill, New Jersey. The company has been in the inferior vena cava (IVC) filter business since the early 1990s. Nearly every Bard IVC filter—particularly its Recovery and G2 series filter—has been at the center of much of the controversy and criticism surrounding inferior vena cava filters.

Initially, Bard was just a distributor of IVC filters. The company signed an agreement with NMT Medical (a company that also designs, develops and markets medical devices) in 1992, giving Bard exclusive rights to distribute NMT’s Simon Nitinol Vena Cava Filter. In November 2001, following a dispute over Bard’s rights to distribute NMT’s new Recovery filter, NMT sold its Vena Cava filter product line, including the Simon Nitinol Filter and Recovery Filter, to Bard for $27 million. NMT received $4 million when Bard took over manufacturing of the Recovery in September 2002 and an additional $3 million in January 2003 after Bard received FDA clearance to market the Recovery Filter. NMT continued to receive royalties on sales of the Bard IVC filter.

Following the clearance of the Recovery Vena Cava Filter, Bard released five other filters, listed below with the year that the U.S. Food and Drug Administration (FDA) cleared each Bard IVC filter to be marketed.

These included:

  • G2 IVC Filter (2005)
  • G2 Express and G2X IVC Filters (2008)
  • Eclipse IVC Filter (2010)
  • Meridian IVC Filter (2011)
  • Denali IVC Filter (2013)

The First Bard IVC Filter: Recovery

When the Recovery filter first obtained FDA clearance, its labeling and promotional materials were required to contain a limiting statement: that the safety and effectiveness of the Recovery Filter as a retrievable had not been established. But in July 2003, the FDA cleared the Recovery to be marketed as a retrievable filter—the first in the United States—with the labeling limitation removed.

An initial 2002 study of the Recovery filter reported encouraging results. Out of 32 patients implanted with the Recovery filter, only three filter complications were observed: two instances of the filter tilting in the inferior vena cava, and once case of filter migration of 4 cm. It should be noted, however, that the study was partially funded by both Bard and NMT Medical.

Both companies had significant financial interests in a positive study outcome. In addition, three quarters of the filters implanted were removed within 134 days, with the filters remaining in place, on average, only 53 days. Since the risk of filter complications appears to increase the longer the devices remain implanted, the early removal of the filters in the 2002 study may explain the absence of any alarming results—this would soon change.

Bard IVC Filter Analysis: The Lehmann Report

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.”

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 Baum Hedlund Aristei & Goldman for a free case evaluation.

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