A single mother from New York is suing over complications she experienced following the implantation of a Bard IVC filter.

Plaintiff Michelle M. says she was implanted with a Bard G2 Express IVC filter in October 2009 and by September 2014, she went to the hospital complaining of abdominal pain.

A new angiogram revealed that the Bard IVC filter had migrated away from its original position and had punctured the vein. Her vascular surgeon determined surgical removal of the IVC filter would be too risky.

Based on these IVC filter complications, Michelle is now suing manufacturers C.R. Bard Inc. and Bard Peripheral Vascular Inc., seeking compensation for her injuries and reimbursement of court costs.

She is charging Bard with defective design, failure to warn, negligence, breach of warranty, and violating New York consumer protection laws.

What is an IVC Filter?

An IVC (inferior vena cava) filter is a device intended to prevent blood clot-related conditions like pulmonary embolisms in patients who are predisposed to those particular conditions but for whom anticoagulant medication is not a good option.

In Michelle’s case, she received an IVC filter because she had a history of deep venous thrombosis and was about to undergo gastric bypass surgery.

The device itself is a small metal basket-shaped filter designed to trap blood clots that form in the lower body and begin to migrate from there up to the lungs or heart.

It is placed inside the inferior vena cava, the vein that returns blood to the heart and the largest vein in the body. Ideally, the filter traps blood clots before they can do greater harm. Then natural anticoagulants in the blood eventually break the clot down while it sits trapped in the filter.

IVC Filter Complications

IVC filter complications occur when the device doesn’t work as planned. There have been reports of filters becoming dislodged from their proper position, as in Michelle’s case, and puncturing the walls of the vein. Michelle alleges that Bard’s G2 and other IVC filters are prone to “fracturing, migrating, tilting and/or perforating the IVC.”

Plaintiff Michelle also draws attention to the fact that Bard used Section 510(k) process to get FDA approval for its IVC filters. The 510(k) process allows for expedited approval of devices that are substantially equivalent to a device that had been “grandfathered” out of the approval requirements of the Medical Device Amendments of 1976.

Devices that meet the “substantially equivalent” requirement may be approved with no new clinical trials. Michelle argues Bard used the 510(k) process to sidestep clinical trials that would have revealed the dangers of IVC filter complications.

Bard IVC Filter MDL

Michelle’s IVC filter lawsuit notes that it may qualify for inclusion in the Bard IVC filter multidistrict litigation (MDL) that is going on in a federal court in Arizona.

This MDL is a consolidation of many similar IVC filter lawsuits from around the country, transferred into a single court to promote more efficient pretrial proceedings. Though she filed her IVC filter lawsuit in New York, Michelle is asking the court to transfer her claim to the MDL in Arizona.

The IVC Filter Lawsuit is Case No. 1:15-dp-20231-DAK in the U.S. District Court for the Western District of New York.