Bard G2 Express IVC Filter Lawsuit Filed After Device Migrated, Punctured Vena Cava

C.R. Bard faces a new product liability lawsuit from a New York woman who claims a G2 Express filter, implanted into her inferior vena cava (IVC) to reduce the risk of pulmonary embolism, punctured the critical vein, leaving her at risk of serious injury and death. 

The complaint (PDF) was filed by Michelle Mercurio in the U.S. District Court for the Western District of New York on September 8, naming C.R. Bard and Bard Peripheral Vascular, Inc. as defendants.

The Bard G2 Express IVC filter is a small, multi-legged device used to “catch” blood clots that may break free from elsewhere in the body before they can reach the lungs and cause a pulmonary embolism. However, in recent years, there have been growing concerns over the risk of complications from IVC blood clot filters, which can migrate out of place and puncture the vena cava, or even fracture into pieces and send shards of metal into the heart or lungs.

Mercurio received the Bard G2 Express IVC filter in October 2009, because she had a history of deep vein thrombosis and was preparing to undergo gastric bypass surgery.

At the time, it appeared that the device was implanted correctly. However, in September 2014, she was suffering abdominal pain and it was discovered during examinations and imaging that her G2 IVC filter had migrated and punctured the vena cava, resulting in several of the struts sticking out of the vein toward the right of her lumbar spine.

According to the complaint, Mercurio’s doctor determined that removing the IVC filter was too risky due to its placement and the requirements of the surgery. As a result, she still has Bard G2 Express IVC filter in her body, facing a continuing risk that the device may migrate again, fracture or cause other problems that may lead to life-threatening complications.

“Plaintiff is a single mother of two children without any support financially or otherwise from the children’s father,” according to the complaint filed by Mercurio. “She lives with constant anxiety, stress and worry that she will have an accident or something will happen that will cause complications with her punctured IVC filter resulting in serious injury or death.”

Bard IVC Filter Problems

Mercurio joins a growing number of individuals nationwide who are pursuing an IVC filter lawsuit over problems associated with several different models of retrievable devices introduced in recent years. All of the lawsuits include allegations that the company failed to warn the medical community about the risks of complications associated with the Bard G2 filter and other IVC filters, including the Bard Recovery filter.

The G2 filter is the second generation version of the Bard Recovery filter, which was itself known to have problems with fracturing and migration and had a very high failure rate. According to the lawsuit, Bard knew the design had problems, had seen reports of filter fractures and migration, but continued selling it anyway, before making minor changes and repackaging it as the G2 filter.

“Defendants marketed the G2 filter as having ‘enhanced fracture resistance,’ ‘improved centering,’ and ‘increased migration resistance,’” the lawsuit notes. “Defendants, however, failed to ensure that the changes made to the device were sufficient to correct the problems that plagued the Recovery Filter resulting in the same defects and health risks.”

A recent investigative report by NBC news also delved into the development of the devices. According to the report, officials in C.R. Bard were warned about the problems by adverse event reports and their own employees, but continued to sell the devices, without warning the medical community of the problems.

One employee, Kay Fuller, a regulatory specialist who worked for Bard on getting the Recovery approved, said she quit when the company would not address her concerns over the device’s health issues, and then forged her signature on the FDA approval application, according to NBC.

IVC Filter Litigation

The litigation over IVC filters emerged following an FDA statement issued in August 2010, which warned about the risk of retrievable filter problems, indicating that the agency had received hundreds of adverse event reports where filters broke free and travelled to other areas of the body or caused other injury.

In May 2014, the FDA urged doctors to remove IVC filters within about one to two months after the risk of a pulmonary embolism has passed, suggesting that many doctors were not adequately warned about the importance of retrieving the devices.

Last month, all Bard G2 IVC filter lawsuits and Bard Recovery IVC filter lawsuits, were centralized as part of a MDL, or multidistrict litigation, in the federal court system, before U.S. District Judge David G. Campbell in the District of Arizona for pretrial proceedings.

The creation of the Bard IVC filter MDL, or multidistrict litigation, was preceeded by a similar MDL created to consolidate all IVC lawsuits filed against Cook Medical. Since October 2014, all Cook Celect and Cook Gunther Tulip IVC filter lawsuits have been consolidated before U.S. District Judge Richard L. Young in the Southern District of Indiana.