Cook Medical and plaintiffs in a multidistrict litigation failed to reach an agreement in a settlement conference early last week. The first trials against Cook Medical over its IVC filters are scheduled to begin this September.

The first trials against Cook were originally scheduled for this past February; however, Cook asked to postpone the trials twice so the company could review cases for a possible settlement conference.

Inferior Vena Cava filters (IVC filters) are small medical devices that are implanted into the large veins carrying blood from the body to the right atrium of the heart. The purpose of the IVC filter is to prevent a deadly condition called pulmonary embolism (PE), or when a blood clot forms in the body, passes into the lungs, and causes serious injury, coma, or death.

Cook received approval for its IVC filters in 2003 through the controversial 510(k) fast track approval process. This allowed the company to rely on clinical data from similar IVC filters trials to aid in approval.

The first lawsuits against Cook Medical were filed in 2012 and slowly continued to climb. By 2015, the company was facing more than 100 lawsuits. In June 2015, a study published in the Journal of Vascular Interventional Radiology found 43% of patients with Cook IVC filters had the device completely perforate the inferior vena cava walls, causing serious medical issues.

The study prompted a wave of new filings and the company is now facing more than 500 lawsuits alleging Cook failed to warn doctors and patients of the risks associated with the device. But Cook isn’t the only one facing lawsuits over IVC filters: Cordis Corporation, C.R. Bard, and Boston Scientific are all facing similar allegations. The first trials against Bard are scheduled to begin in early 2017.