A Virginia woman says she would have chosen a different treatment for blood clots if she had been given a proper warning about IVC filter risks.

Plaintiff Allene K. alleges the potential IVC filter risks were not sufficiently explained on the Cook Celect Vena Cava Filter’s warning label, which would have impacted the decision to have the product implanted.

Like other IVC filters, the Cook Celect Vena Cava Filter was meant to help mitigate the risk of serious blood clot complications.

IVC filters are small metal cage like devices that are implanted in the inferior vena cava (IVC), which is the largest vein in the human body and a vital component of the circulation system. IVC filters work by trapping and preventing blood clots that form in the legs and pelvis from traveling to the heart or lungs, where they can do life-threatening damage.

IVC filters are typically recommended to patients who cannot be prescribed anticoagulant treatment. With these benefits in mind, Allene agreed to use the Cook Celect Vena Cava Filter and had it implanted on May 12, 2009.

However, Allene alleges she has since suffered serious device complications related to IVC filter risks.

Overview of IVC Filter Risks

IVC filter risks stem from long term use of these devices after the risk of blood clots has passed. The FDA stresses that these medical devices should be removed as soon as possible after the blood clot risk is resolved.

The longer these devices stay inside the patient, the higher the likelihood of IVC filter risks causing problems. The FDA warned against IVC filter complications in 2010, stating it had received 921 injury reports stemming back to 2005. These IVC filter injury reports included:

• 328 reports of IVC Filter Migration
• 146 reports of IVC Filter Component Detachment
• 70 reports of IVC Filter Perforation of Inferior Vena Cava
• 56 reports of IVC Filter Fracture

In this warning, the FDA stated that retrievable IVC filter use is meant for short term use only and would later release a warning specifying the recommended time frame to remove the device. In May 2014, the FDA stated retrievable IVC filters should generally be removed between 29 to 54 days after implantation.

If left inside patients any longer, the IVC filter may break apart and perforate the inferior vena cava. This means that different device components may migrate into different areas of the chest cavity or other parts of the body, which can severely complicate the patient’s health. In addition, this makes removing the IVC filter much more difficult and sometimes impossible.

Allene states she would not have allowed for Cook Celect Vena Cava Filter to be implanted if they had been aware of the potential IVC filter risks. At all times relevant, Allene says she relied on the marketing statements and product information provided by Cook Medical and no reason to believe they were at risk for serious device complications.

Allene’s IVC filter lawsuit is joining MDL No. 2570, where it will stand alongside other product liability claims alleging the company failed to warn against IVC filter risks.

This IVC Filter Lawsuit is Case No. 1:18-cv-03790-RLY-TAB, in the U.S. District Court of Southern Indiana, Indianapolis Division.