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Widow Blames Bard G2 IVC Filter for Her Husband’s Death

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A new Bard IVC filter lawsuit has been filed in the Eastern District of Missouri. On September 28, 2015, the plaintiff, individually and on behalf of the estate of her husband, filed a complaint against defendants C.R. Bard, Inc., and Bard Peripheral Vascular, Inc.

The plaintiff, a resident of St. Louis, Missouri, claims that because of a defective Bard G2 Filter, her husband passed away on September 28, 2012. She seeks in excess of $75,000 in damages.

In August 2015, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal Bard IVC filter lawsuits into the District of Arizona for pre-trial proceedings. It is expected that this case will soon be transferred there.

Defective Bard G2 Filter Malfunctions

According to the complaint, the plaintiff’s husband was implanted with a Bard G2 IVC filter on November 16, 2006. The anchoring system of the filter subsequently failed, leading it to tilt on its side and perforate the vena cava—the vein in which it was implanted.

IVC (inferior vena cava) filters are designed to be implanted in the vein that takes blood from the lower legs back to the lungs and heart. Small, cage-like devices, they “catch” blood clots and hold them until they dissipate, to prevent them from traveling from the legs to the lungs where they could cause a pulmonary embolism (PE).

In this case, after the filter tilted and perforated the vein, it could no longer perform its function of catching blood clots in the way that it was supposed to. The plaintiff states in her complaint that her husband died “as a result of the defective G2 filter failing to perform its intended function of preventing clots from moving to the heart or lungs.”

Problems Arise with Bard G2 IVC Filters

The FDA approved the Bard G2 filter in August 2005. The device manufacturer did not submit clinical trials proving its effectiveness, however. They went through the FDA’s fast-track 510k process, which required only that they prove the device was substantially similar to one already on the market. They showed that the G2 filter was similar to one of their older devices, the Bard Recovery IVC filter.

The company advertised the G2 filter as having enhanced fracture resistance, and improved centering. Yet both devices were found to have high rates of failure following implantations. For example, a 2010 study compared Bard Recovery and Bard G2 IVC implanted in patients between April 2004 and January 2009. They told the FDA that 25 percent of the Bard Recovery filters fractured, and 12 percent of the Bard G2 filters fractured.

Indeed, within months of being on the market, the Bard G2 IVC filter was linked to large numbers of reports indicating that the device was fracturing, migrating, tilting, and perforating the vena cava, resulting in serious injuries and sometimes, death. By February 2006, internal investigations conducted by the manufacturer showed that the G2 filter’s design failed to ensure adequate stability—the filter was still tilting and migrating at unreasonably high rates.

In a document dated April 1, 2010, Bard employees discussed the known quality problems with the G2 line of filters. This information was not disclosed to the public.

Plaintiff Seeks Punitive Damages

The plaintiff in this case brings counts of negligence, failure to warn, design defect, manufacturing defect, breach of warranties, fraud and concealment, and wrongful death. She seeks compensatory and punitive damages.