Plaintiff Emily L. of Georgia is suing C.R. Bard Inc. and its subsidiary Bard Peripheral Vascular Inc. over complications involving their G2 Filter System.

Emily had a Bard G2 inferior vena cava (IVC) filter implanted in February 2012. By July 2013, she began experiencing chest pain. A cardiac catheterization and angiogram showed that the IVC filter had fractured and a strut from the filter had migrated to her heart. Doctors removed the rest of the broken filter but were unable to remove the piece lodged in her heart. Emily alleges the residual IVC filter strut causes ongoing pain and suffering and will require continued medical monitoring.

An IVC filter is a device used to prevent blood clots from moving from the lower part of the body up to the heart or lungs. These clots that form often in the legs can develop into a condition known as deep vein thrombosis. Should these clots become loose and travel to the lungs, they may result in pulmonary embolism.

IVC filters are used to prevent pulmonary embolism in patients who are particularly at risk for it. Obese patients, recent recipients of prosthetic hip or knee replacements, and persons with clotting disorders may be at risk for pulmonary embolism. For patients in whom the risk of pulmonary embolism is only temporarily increased, some IVC filters are designed to be removed after the risk subsides.

IVC Filter Lawsuit

Emily’s IFC lawsuit alleges that the G2 IVC filter had “an unreasonably high rate of fracture, migration, excessive tilting, perforating the vena cava wall once implanted in the human body.” She cites studies that found the device fractured or migrated at rates of 21 to 31.7 percent, higher rates than those of other IVC filters. She says these potential failures exposed recipients of the G2 filter to an increased risk of complications like hemorrhage, cardiac arrhythmia, perforation of tissue and organs, and possibly death.

Emily alleges Bard knew about these potential hazards but failed to properly warn patients or their physicians about them. She claims Bard received increasing numbers of adverse event reports from 2003 to 2005, alerting the company to the incidence of failures.

Her lawsuit also alleges Bard avoided conducting proper clinical trials on the G2 filter by taking advantage of the FDA’s 510(k) process, which allows for approval of new devices without trials if the devices are substantially similar to older devices already approved.

Emily further cites a determination by the FDA that the G2 filter and the Recovery Cone Removal System used to extract the filter from the body were “adulterated and misbranded,” making Bard’s marketing of those products a violation of federal law.

Emily’s IVC filter lawsuit raises claims for negligence, negligent failure to warn, strict liability failure to warn, strict products liability for defective design and defective manufacture, breach of warranty, fraudulent concealment, and negligent misrepresentation. In addition to her request for general and specific damages, Emily is asking the court for an award of punitive damages, based on Bard’s allegedly “intentional, willful, knowing, fraudulent” and “malicious” conduct.

This IVC Filter Lawsuit is Case no. 1:15-CV-02672, in the U.S. District Court for the Northern District of Georgia.