An investigation has raised questions about the way medical device manufacturer C.R. Bard handled reports of IVC filter complications.

The reports are related to the company’s Recovery IVC filter, a device used to trap blood clots and prevent them from reaching the heart or lungs.

An investigation by NBC revealed that Bard continued to sell the Recovery filter despite hundreds of reports of IVC complications, some of which ended in death.

An IVC filter is a small, basket-like device designed to be placed inside the inferior vena cava, the large vein that returns blood to the heart. When it works as intended, the filter captures blood clots and holds them in place, giving the blood’s natural anticoagulants a chance to dissolve them safely. IVC filters are used as an alternative way to prevent embolism in patients for whom anticoagulant medications are not a good option.

Problems have reportedly arisen with certain IVC filters, like the Recovery, which have led to potentially deadly IVC filter complications. Some filters have fractured, allowing the pieces to migrate to the heart and puncture it. In other cases, the entire filter has migrated out of its proper position.

According to the NBC investigation, at least 27 deaths over a 10-year period have been reported in association with the Recovery filter. Other reports show over 300 instances of non-fatal injuries.

Bard commissioned an internal study of the Recovery filter by an outside doctor. The doctor concluded that compared to its competitors, the Recovery filter had higher relative risk of death, fracture and movement.

Yet despite these many reports of IVC filter complications, Bard did not recall the Recovery filter. The company continued to sell around 34,000 Recovery filters before replacing it with a new design called the G2 filter.

Kay Fuller, a regulatory specialist hired by Bard to help get FDA approval for the Recovery IVC filter, told NBC that the company withheld safety information about the Recovery filter from her. One clinical trial raised certain concerns about the filter, she said; yet Bard declined to provide her with the results of safety testing.

Fuller says that after she had raised serious concerns about the device, she was led to understand that if she persisted in questioning the safety of the Recovery filter, she would be removed from the team.

Fuller insisted that she would not sign the application for FDA approval until the safety issues were resolved. To date, she says she did not sign the application that Bard sent to the FDA. Yet the application bears her handwritten name over a line labeled Senior Regulatory Affairs Specialist. Fuller says that signature does not match her own.

IVC Filter Lawsuits

In October 2014, 27 Bard IVC filter lawsuits were combined into a single multidistrict litigation (MDL) in an Indiana federal court. The plaintiffs in these IVC filter lawsuits generally allege that the Recovery filter is defective and dangerous. They say that Bard misrepresented the safety of the Recovery filter, and that if the plaintiffs had known the truth they would not have agreed to have the Recovery filter implanted.