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Missouri Woman Files Bard IVC Filter Lawsuit, Claiming Back Pain

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On November 24, 2015, a St. Louis, Missouri woman filed a new Bard IVC filter lawsuit in the Eastern District of Missouri. The U.S. Judicial Panel on Multidistrict Litigation (JPML) established the Bard IVC filter MDL in August, with all federally filed cases transferred to the District of Arizona, and it is expected that this case will also be transferred there.

The plaintiff blames the manufacturers for failing to provide adequate warnings about the risks associated with their product, the Bard G2 filter system. The plaintiff claims to have suffered serious injuries after the device was implanted in her body.

Plaintiff Suffers Back Pain from Fractured Bard G2 IVC Filter

The Bard G2 IVC filter is a small, cage-like medical device that is designed to help reduce the risk of a pulmonary embolism (PE), which is a blood clot in the lung. The device is implanted in the inferior vena cava, the main vein transporting blood from the legs back up to the heart and lungs. There, it is supposed to trap blood clots before they can reach these vital organs and hold them there until they dissipate and the danger is gone.

According to her complaint, the plaintiff was implanted with the G2 filter in September 2008. The filter, however, subsequently failed. One of the struts or “legs” of the device broke off the main body, and became lodged in the plaintiff’s back. As a result, she says she has suffered significant medical expenses and endured extreme pain and suffering.

The plaintiff claims that the defendants failed to conduct clinical tests to determine how the device would function once permanently implanted in the body, and that they should have known that the filter had a high rate of fracture and migration.

Bard Markets G2 as Improved Version of Recovery

A 2010 study found that 16 percent of implanted Bard Recovery and Bard G2 filters implemented fractured. In five of those cases, pieces of the filter migrated to the heart, causing life-threatening complications.

In 2010, the FDA warned that IVC filters could cause serious injuries, and in 2014, they updated that communication to recommend that doctors remove the devices as quickly as possible once the risk for PE had passed, optimally within 29-54 days.

The G2 system received FDA approval in August 2005. The product was not put through clinical tests, but rather, went through the fast-track 510(k) approval process, which requires only that it prove it was substantially similar to another device already on the market. Bard did that, comparing the G2 with its previous product, the Bard Recovery.

Bard then advertised the G2 as being an improved version of the Recovery, having enhanced fracture resistance and improved migration resistance. However, they had no clinical studies to back up these claims. The plaintiff states in her complaint that the G2 filter “is not of sufficient strength to withstand normal placement within the human body,” and is therefore susceptible to failure.

The plaintiff goes on to say that the defendants should have known when they were selling the G2 that it created a significant risk of injuries such as hemorrhage; cardiac arrhythmia; perforations of tissue, vessels, and organs; and other severe injuries. She brings counts of negligence, failure to warn, design and manufacturing defects, breach of warranties, and consumer fraud.