IVC Filter Problems Did Not Stop C.R. Bard From Selling Them, NBC News Report Shows

Amid a growing number of IVC filter lawsuits filed by individuals nationwide who experienced complications after receiving a device to prevent a pulmonary embolism, a new investigative report suggests that one of the leading manufacturers of the blood clot filters has known for years that their products may cause severe and potentially life-threatening injuries.

Inferior vena cava (IVC) filters are designed to “catch” blood clots that may break free within the body, preventing them from traveling to the lungs. However, the devices have been linked to thousands of reports involving problems where the filter punctured the vein, migrated out of position or fractured, often sending small metal pieces into the heart or lungs.

In an NBC News report published online December 31, internal records obtained by the network reveal that C.R. Bard was aware of the risk of IVC filter problems just months after one of their most popular models was introduced in 2005, the Bard G2. However, the company continued to sell the device for another five years.

By 2010, the Bard G2 IVC filter had been linked to at least 12 deaths and hundreds of injuries, according to the report. On top of that, the G2 was meant to replace the problematic Bard Recovery Filter, which suffered from many of the same problems. Combined, the two product lines have been linked to at least 27 deaths, according to the report.

In recent years, concerns over the safety and effectiveness of retrievable IVC filters, such as the Bard G2 and Bard Recovery, have result in questions about whether the benefits outweigh the risks, and hundreds of product liability lawsuits have been filed in state and federal courts throughout the U.S.

Signs of Problems with IVC Filters

The litigation over IVC filter problems first emerged in 2010, after the FDA indicated that more than 900 adverse event reports had been received involving the devices. Of those reports, 328 involved the IVC filter breaking free and migrating through the body, 146 involved  components breaking loose, 70 involved the inferior vena cava being perforated and 56 involved the filter fracturing.

In May 2014, the FDA urged doctors to remove IVC filters within about one to two months after the risk of a pulmonary embolism has passed, suggesting that many doctors were not adequately warned about the importance of retrieving the devices.

According to documents obtained by NBC News, internal C.R. Bard memos already warned about the risk of problems with IVC filters by December 2005, raising concerns about G2 filters tilting out of position, as well as cases of perforation, migration and mis-deployment. The memo also asked why the company wasn’t promoting the SNF filter, which had “virtually no complaints associated with it.”

The Bard G2 filter was introduced after a confidential study determined that the company’s earlier Bard Recovery filter had a high rate of patient deaths, fractures and migrations, exceeding those linked to any other IVC filter on the market at the time.

Despite indications that the manufacturer was aware of the IVC filter risks, the Bard G2 was sold until 2010, the same year the FDA issued its warning about the reports of IVC filter problems.

IVC Filter Litigation

In the federal court system, there are currently at least 72 Bard G2 filter lawsuits, Bard Recovery filters lawsuits and other cases pending involving IVC filters manufactured by C.R. Bard. Since August 2015, the Bard IVC filter lawsuits have been centralized before one judge in the District of Arizona, as part of a federal MDL, or multi-district litigation.

Each of the complaints raise similar allegations that the small devices are unreasonably dangerous, and contain inadequate warnings about the potential risk of problems with IVC filters.

Similar lawsuits have also been filed against Cook Medical involving their retrievable IVC filters, which have also been linked to reports of problems. In a separate MDL, there are currently at least 170 Cook Celect and Gunther Tulip IVC filter lawsuits pending in the Southern District of Indiana, where a small group of cases are being prepared for early trials that may begin later this year.

As IVC filter injury lawyers continue to review and file complaints on behalf of individuals who have suffered migration or perforation problems, it is ultimately expected that several thousand cases will be filed against Bard, Cook and other manufacturers of the devices.