Georgia Woman Undergoes Open-Heart Surgery to Remove Bard G2 Filter Piece
On August 17, 2015, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal lawsuits concerning Bard IVC filters into the District of Arizona for coordinated pre-trial proceedings. Since that time, more plaintiffs have come forward with complaints against the manufacturer, with many more expected to join the litigation in the coming months.
On September 2, 2015, a couple from Atlanta, Georgia filed a new complaint in the Northern District of Georgia. The complaint will be transferred to Arizona. The plaintiffs claim that the Bard G2 filter, which is used to help reduce the risk of pulmonary embolism, caused serious injuries.
Bard G2 Filter Linked with a High Rate of Fractures and Migration
The Bard G2 IVC filter is a temporary, cage-like medical device that is implanted into the inferior vena cava (IVC)—the large vein that transports blood from the lower legs back to the heart. It is this vein that can present a health risk if a blood clot forms in the lower legs and travels upward to the lungs. Such a clot can cause a pulmonary embolism (PE), a blood clot in the lung, which is a potentially life-threatening condition.
The Bard G2 has little legs or “struts” that capture blood clots and hold them until they dissipate, reducing the risk of PE. This particular filter, however, has been linked with higher-than-expected rates of fractures and migration, where a piece of the filter breaks off and migrates to another part of the body, potentially causing health problems.
A 2010 study, for instance, found that out of a total of 80 patients who received a Bard G2 IVC filter, 16% had filters that fractured, with five patients suffering from fragments that perforated the heart and presented life-threatening complications.
That same year, the FDA released a safety communication warning healthcare professionals that IVC filters could cause serious injuries. In 2014, the FDA updated that communication to recommend that the filters be removed as soon as the risk of PE had passed—optimally between 29 and 54 days after implantation.
Plaintiff’s Bard G2 Filter Fractures and Penetrates the Heart
According to the Georgia couples’ complaint, the woman was implanted with a Bard G2 filter system in February 2008. She later discovered in January 2014 that a “leg” or strut from the filter had broken off and migrated to her heart, where it perforated the muscle. She had to undergo open-heart surgery to have the strut removed, and to have the rest of the filter taken out.
Unfortunately, when they were finished with the procedure, surgeons reported that one more leg of the filter was missing and could not be found. They expressed concern that because the missing leg is still in the plaintiff’s body, it may one day cause additional health problems.
Bard Should Have Provided More Accurate Warnings
Bard started selling the G2 IVC filter in 2005, and continued through 2015. The company has stopped manufacturing it now, in favor of a newer model. Bard touted the G2 (named for “second generation”) as an upgrade from a previous filter called the “Recovery,” which was also linked to a higher-than-normal rate of fracture and migration.
The Georgia plaintiff claims she has suffered significant pain and suffering because of these problems with the filter, and that she has incurred considerable medical expenses. She also claims that Bard was aware of the problems with the filter, and should have done more to warn patients and physicians of the risks. She and her husband bring negligence, failure to warn, defective design and manufacturing, and breach of warranties claims against the device manufacturers.