A year-long investigation conducted by NBC Nightly News has raised serious concerns about medical device company C.R. Bard’s handling of reported issues with  its Recovery IVC filter.

The investigation revealed that more than 300 adverse events, including at least 27 fatalities, have been associated with the Recovery IVC filter device in the last decade. The Recovery IVC filter is implanted into a patient’s inferior vena cava, the body’s largest vein, to keep blood clots from entering the heart or lungs.

However, the Recovery IVC filter can break, embedding pieces into major organs.

The NBC News report also disclosed a confidential study commissioned by C.R. Bard in 2004 which linked the Recovery IVC filter to higher rates of death, fracture and movement compared to its competitors.

While the author of the report asserted that “further investigation” of the matter was “urgently warranted,” C.R. Bard opted not to recall the product.  For nearly three years, the company sold about 34,000 Recovery IVC filters before replacing it with a modified version sold under a different name.

Many Recovery IVC filter patients claim to have suffered complications.  One of those people was Dodi F., a 45-year-old single mother of two from Florida.

Dodi, who is now suing Bard, had a Recovery IVC filter implanted in 2004 as a precautionary measure after a car accident. She was believed to be at an increased risk of blood clots due to immobilization and pelvic fracture. “The filter was supposed to stop them from reaching her heart or lungs; instead, it nearly killed her,” the NBC investigation says.

Four months after receiving the IVC filter, Dodi developed a severe headache and passed out, the story said, adding that she flat-lined in the ambulance on the way to the hospital.

It took two days for doctors to discover what was causing her symptoms. A piece of the IVC filter had broken off and pierced her heart. Medical records show that blood was draining from her heart into the pericardial sac, preventing the heart from pumping correctly.

Dodi was rushed into emergency open-heart surgery, where surgeons were able to remove the broken piece, drain the pooling blood from around her heart, and stitch the perforation closed.

Bard IVC Filter Lawsuits

IVC filters, including Bard’s Recovery device, are intended to be implanted in the inferior vena cava to block blood clots from traveling to the lungs. In 2005 the company replaced the Recovery filter with the G2 IVC Filter system. Both are retrievable filters, and are intended to be removed once the danger of blood clots has passed.

In 2010, the FDA disclosed that retrievable IVC filters had been associated with more than 900 adverse events, including incidents of migration, fracture and embolization, and perforation of the inferior vena cava.

In 2014, the agency issued a new advisory to remind doctors that retrievable IVC filters should be removed 29 to 54 days of their implantation. However, a study that appeared in JAMA: Internal Medicine in April 2013 suggested that successful IVC retrieval occurred in only 10% of patients.

C.R. Bard has been named in dozens of IVC filter lawsuits, which claim that the Recovery and G2 medical devices are prone to  fracture, migrate, tilt or perforate the inferior vena cava, resulting in serious injury to patients.

On Aug. 17, the U.S. Judicial Panel on Multidistrict Litigation transferred all federally filed Bard IVC filter cases to the U.S. District Court, District of Arizona to coordinate pretrial proceedings.

The Bard IVC Filter MDL is In Re: Bard IVC Filters Products Liability Litigation – MDL No. 2641.