Pharmaceutical

Bard faces first IVC bellwether trial in March

IVC filter 294x210 Bard faces first IVC bellwether trial in MarchThe first bellwether trial among thousands pending in a multidistrict litigation centralized in the U.S. District Court of Arizona blaming C.R. Bard’s blood clot catching device for serious injuries and death is scheduled to begin March 14, 2018, before U.S. District Judge Daivd G. Campbell.

The lawsuits allege that C.R. Bard failed to warn doctors or patients about dangerous side effects associated with its IVC filters, small, cage-like devices that are implanted in the inferior vena cava (IVC), a large vein that carries deoxygenated blood from the lower extremities to the heart. They are designed to capture blood clots before they reach the heart or lungs.

But the devices have been linked to serious complications, including filter migration, fracture, organ perforation, embolization and IVC perforations.

Cook Medical, another major IVC filter manufacturer, is also facing thousands of IVC filter lawsuits in a multidistrict litigation (MDL) pending in the Southern District of Indiana. Other companies facing IVC filter lawsuits in state and federal courts include Cordis Corporation, Rex Medical, B. Braun and Argon Medical.

An estimated 30,000 IVC filters have been implanted in patients in the past thee decades. In 2010, after receiving thousands of adverse event reports associated with retrievable IVC filters, the Food and Drug Administration (FDA) issued a warning about the devices. Four years later, the agency strengthened that warning, urging doctors to remove the devices within a month or two after the patient’s blood clot risk is reduced.

In 2015, a media outlet linked C.R. Bard’s Recovery Model IVC Filter to at least 27 deaths and 300 injuries, but the company continued to manufacture and sell the device without warning doctors or patients of the serious risks associated with use.

Source: U.S. District Court District of Arizona