A Kentucky woman’s IVC filter lawsuit says the device’s manufacturer failed to adequately warn her about the risks associated with the device.

Plaintiff Katherine M. says she was hospitalized with a right lower extremity deep vein thrombosis in May 2005.

Two days later, she says, she underwent a clot extraction procedure and IVC filter placement, using a Greenfield inferior vena cava filter made by defendant Boston Scientific Corporation.

In the IVC filter lawsuit, Katherine says that years later, in July 2010, she had to see her doctor twice for symptoms that may have been IVC filter side effects related to an occlusion, or blockage, of the device.

She says that imaging studies performed in August of that year confirmed her IVC filter was occluded. Because of that occlusion, Katherine claims, she must now take anticoagulant drugs for the rest of her life.

Katherine’s IVC filter lawsuit alleges her IVC filter side effects are attributable to a failure on the part of Boston Scientific to properly warn her about them.

According to her IVC filter lawsuit, she claims the company “knew or should have known that its Greenfield Vena Cava Filter when used as expected and intended, had the possibility of shifting, breaking free its implantation site, migrating, perforating the vena cava, and causing serious injury and/or death” to its recipients.

This IVC filter lawsuit raises claims for negligence, gross negligence, product liability strict liability and breach of warranty.

Katherine seeks a damage award in excess of $75,000, including punitive damages to punish Boston Scientific’s allegedly “willful and wanton misconduct and gross negligence,” plus court costs and attorneys’ fees.

IVC Filter Lawsuit Background

The device at issue in Katherine’s IVC filter lawsuit is used to prevent blood clots from traveling from the lower body to the upper body. If a clot travels to the upper body, it can potentially do much greater damage like pulmonary embolism.

It may be suitable for patients for whom anticoagulant drugs are not a good option.

IVC filter placement involves positioning the device within the inferior vena cava, the large blood vessel that returns blood from the lower body to the heart and lungs. The small, basket-like device then traps blood clots on their way to the lungs and holds them in place.

Complications associated with these devices have been the subject of hundreds of reports to the FDA. In 2010, the agency noted it had received 921 reports related to potential IVC filter side effects between 2005 and 2010.

In a large number of those cases, the device had migrated out of place. Other devices had come apart after implantation, letting fragments loose within the bloodstream. In some patients, the filter punctured blood vessel walls.

In some cases of failure, IVC filter removal itself failed. One study published in the Journal of the American Medical Association in 2013 found that over 18 percent of attempts at IVC filter removal failed.

The FDA updated its recommendations in 2014, urging physicians to remove any retrievable IVC filter as soon as it is no longer needed, to avoid the risks of complications.

The IVC Filter Lawsuit is Case No. 5:16-cv-65-TBR in the U.S. District Court for the Western Division of Kentucky, Paducah Division.