Plaintiff Theda B. has filed suit against the makers of the CR Bard IVC filter that allegedly perforated her vena cava, the body’s largest vein.

An IVC (inferior vena cava) filter is a small device implanted in the inferior vena cava as an alternative to the patient taking blood thinning medications.

The inferior vena cava sends blood back to the heart and lungs from the lower extremities. An IVC filter is an open-ended, cage-like device designed to capture blood clots before they travel to the heart or lungs.

In late October 2007, Theda underwent surgical placement of the G2 CR Bard IVC filter.

Several of the filter’s struts perforated her vena cava and the filter also became tilted and misaligned.

In June 2016, Theda underwent surgical removal of the G2 CR Bard IVC filter. She spent six days in the hospital, endured physical therapy, and experienced an extended period of recovery.

CR Bard IVC Filter Makers Knew of Dangers

Theda’s complaint alleges that as early as 2005, Bard knew the G2 filter “was defective and unreasonably dangerous and was causing injury and death to patients who had received” the G2 CR Bard IVC filter.

The FDA reported 921 adverse events in a warning issued in August 2011 about the risks of complications from IVC filters.

Bard is accused of “off-label marketing” the G2 filter by touting the device as “safe and effective for retrievable use prior to the FDA approving the G2 Filter System for retrievable use in 2008.”

In addition, the G2 CR Bard IVC filter “suffers from manufacturing defects.” The filter is designed with “insufficient integrity and strength to withstand normal placement within the human body,” due to the stressors of the respiratory and cardiac pressures that cause device fatigue.

The G2 also shows noticeable grinding marks on its exterior surface. These places are at higher risk of breaking because the struts are weak in these areas.

Bard continued to advertise the G2 as having “enhanced fracture resistance,” “improved centering,” and “increased migration resistance.” The company claims a fracture rate of only 1.2 percent.

Not so, according to the high number of device fracture reports the FDA shows attributed to the G2 filter. The FDA’s database on Manufacturer and User Facility Device Experience (MAUDE) indicates several reports of fractures, failures and device migration of the G2 filter.

A patient who experiences IVC fracture or migration may feel an acute onset of chest pain and shortness of breath that usually culminates with a visit to the emergency room.

Some patients find out a G2 CR Bard IVC filter has actually attached to internal tissue, resulting in an inability to have the device removed. Such patients must be medically monitored, because the device will remain permanently implanted for their lifetime.

The CR Bard IVC Filter Lawsuit is Case No. 3:17-CV-00193-SDD-RLB in the 19^th Judicial District Court for the Parish of East Baton Rouge Case No. 655951, Division 26, State of Louisiana.

If you or a loved one suffered IVC filter side effects such as migration, IVC perforation, DVT or pulmonary embolism, you may have a legal claim. An IVC filter lawsuit may help you obtain compensation for your medical bills, pain and suffering, lost wages and more.