Bard G2 Filter Lawsuit Alleges Device Tilted, Penetrated Wall of IVC

A Mississippi man has filed a product liability lawsuits against C.R. Bard, alleging that complications from a G2 IVC filter caused him to suffer severe internal injuries when the small implant tilted and the struts penetrated the wall of his inferior vena cava (IVC).

The complaint (PDF) was filed by Clifford Geter in the U.S. District Court for the Southern District of Missouri on June 2, joining a growing number of Bard IVC filter lawsuits filed recently by consumers who have suffered similar problems.

IVC filters are spider-like devices that are implanted into the inferior vena cava, designed to “catch” blood clots that may break free inside the deep veins of the body and travel toward the lungs, preventing a pulmonary embolism.

The Bard G2 filter is one of a new breed of IVC filters designed to be retrievable after the risk has passed. However, it has also been linked to reports of the filter failing, with struts fracturing or penetrating internal organs.

Geter indicates that he underwent Bard G2 IVC filter surgery in October 2008. Nearly four years later, it was discovered that the Bard filter had tilted and the struts penetrated the IVC wall, with at least one strut adjacent to the common iliac artery, another in the right paraspinal region, another strut fractured and within a hepatic vein.

Extensive medical treatment and surgical procedures were required in an attempt to remove the Bard G2 filter, which were largely unsuccessful. As a result, the complaint indicates that he continues to face a risk of life-threatening complications and the need to carefully monitor the G2 filter pieces remaining in his body to ensure it does not cause further injury.

The Bard G2 is a “second generation” IVC filter, which was introduced as a replacement for the Bard Recovery IVC filter. Both devices have been linked to reports of severe complications.

Geter’s complaint and other similar Bard IVC filter lawsuits allege that the manufacturer sold a defective and unreasonably dangerous device, failing to adequately warn the medical community about the risks associated with implanting the device and the importance of removing the filter once the pulmonary embolism risk has passed.

Bard IVC Filter Lawsuit Consolidation

With a growing number of product liability lawsuits filed in recent months over Bard IVC filters, a motion was filed last month with the U.S. Judicial Panel on Multidistrict Litigation (JPML), seeking to centralize all Bard filter lawsuits before one judge for coordinated pretrial proceedings.

In October 2014, the U.S. JPML established similar centralized management, known as an MDL or Multi-District Litigation, for all Cook IVC filter lawsuits filed over similar devices manufactured and sold by one of Bard’s competitors in the industry.

The litigation over IVC filters has emerged since 2010, when the FDA issued an alert about the risk of risk of problems with removable IVC filters.

At that time, the agency indicated that more than 900 adverse event reports had been received at that time, with 328 involving the IVC filter breaking free and migrating through the body. At least 146 involved  components breaking loose, 70 involved the inferior vena cava being perforated and 56 involved the filter fracturing.

The FDA recommended that doctors remove the filters once the danger of the clot has passed, to reduce the risk of the filters breaking free and traveling through the body.

In April 2012, a study published in the medical journal Cardiovascular Interventional Radiology indicated that nearly 100% of Cook Celect and Gunther Tulip IVC filters perforated patients’ venal cava wall within 71 days of being implanted. The study also found that 40% of the filters became tilted and out of position.

A study published in the medical journal JAMA Internal Medicine in March 2013 raised questions about the effectiveness of IVC filters, indicating that less than 10% of filters evaluated in the study were successfully removed from patients and 8% of recipients of IVC filters suffered a pulmonary embolism despite the device’s presence.

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.

Over the past three years, confidential Bard IVC filter settlements have reportedly been reached in several individual cases, often as trial was about to begin or underway. Plaintiffs’ attorneys indicate that additional cases will be pursued through the court system, since no progress has been made to settle large numbers of unfiled cases.

Geter’s complaint pursues claims against Bard for negligence, failure to warn, strict liability, designing and manufacturing a defective medical device, breach of warranty, fraudulent concealment, negligent misrepresentation and fraudulent misrepresentation. He is seeking both punitive and compensatory damages.