A recent IVC filter lawsuit claims that Bard knowingly manufactured and distributed a defective medical device which endangered patients.

Plaintiff Nicholas M. reportedly had a Bard IVC filter placed in October 2014. He claims that as a result of defects associated with the filters, he suffered injuries due to tilting, perforation, and other filter complications.

Inferior vena cava filters, also known as IVC filters, are often used to treat deep vein thrombosis, large blood clots that form in the deep veins of the legs. These clots then travel up the vena cava where they can become lodged in the blood vessels of the lungs. When these vessels are blocked, it is called a pulmonary embolism.

Pulmonary embolisms can be life threatening, so IVC filters may be placed in the blood vessel to catch and break up clots before they reach the lungs. IVC filters are mounted in the vena cava in a procedure usually completed by an interventional radiologist, a doctor that used imaging technology to guide procedures.

Bard makes several IVC filters including the Recovery, G2, G2 X, Eclipse, Meridian, and Denali filters.

An article published in Seminars in Interventional Radiology noted that, while IVC filters have been shown to be “effective in the prevention of pulmonary embolism”, they are associated with notable complications and risks.

One surprisingly common complication associated with IVC filters is perforation. This occurs when the struts of the filters fully penetrate the wall of the inferior vena cava instead of simply mounting the device on the vessel walls. According to the article, perforation of the vena cava may occur between 40 percent and 95 percent of the time.

Another one of the risks associated with IVC filters in migration. This happens when a filter moved out of its original position. If an IVC filter migrates, it can end up in another part of the vena cava or even in the heart. When migration occurs, surgery may be required to remove the device.

Fracturing of the filter can also happen, involving pieces of the filter to break off of the main body. This may also lead to an increased risk of vena cava perforation if large and sharp pieces result from fracturing.

“[V]arious complications associated with these filters have been described, and early diagnosis and management are the keys to reducing patient morbidity and mortality,” the article concludes. “Limited studies of retrievable filters are promising, but further studies are warranted to fully evaluate the risks associated with both implantation and retrieval.”

Nicholas argues that these complications occur frequently with Bard IVC filters due to a defect with the company’s devices. He claims the devices are not designed to withstand the force of blood flow through the vena cava, meaning that the normal, healthy flow of blood causes Bard filters to shift and move out of place.

Nicholas accuses Bard of negligence, strict liability, failure to warn, design defect, manufacturing defect, breach of warranties, fraudulent concealment, negligent misrepresentation, fraudulent misrepresentation, and violation of New York consumer protection laws. Nicholas’ wife Ann M. is also participating in the IVC filter lawsuit.

The IVC Filter Lawsuit is Case No. 6:19-cv-06126-MAT in the U.S. District Court for the Western District of New York.