A woman suing New Jersey-based medical device company C.R. Bard over claims that its G2 IVC Filter, a second-generation blood clot-catching device, caused her serious injuries, will be able to provide evidence that the company’s first-generation Recovery IVC Filter was just as defective.

The case is the first bellwether to go to trial in a multidistrict litigation in the U.S. District Court of Arizona accusing C.R. Bard of manufacturing IVC filters that are defective and prone to fracture and migrate, wreaking havoc inside patients’ bodies. The trial is scheduled to begin March 14.

The trial involves the case of Sherr-Una Booker, a Georgia resident who was implanted with C.R. Bard’s G2 IVC Filter. The filters are tiny cage-like devices that are implanted in the inferior vena cava (IVC), a large vein that delivers deoxygenated blood from the lower extremities to the heart. The filters are designed to catch blood clots traveling from the legs and prevent them from reaching the heart or lungs, which can lead to life-threatening complications.

Booker claims that after being implanted with the G2 IVC Filter, it tilted and fractured, then migrated within her body, perforating her inferior vena cava. She endured invasive surgeries to remove the filter and its fractured metal struts. But one of the filter’s legs could not be removed, and remains embedded in the wall of her inferior vena cava.

The G2 IVC Filter is the second-generation blood clot filter manufactured by C.R. Bard. The first generation was the Recovery, which was sold from 2003 to 2005. During that time, there were more than 300 non-fatal adverse events and 27 deaths linked to the Recovery IVC Filter, according to a 2015 NBC News report. The company’s G2 IVC Filter was intended to be safer.

But an internal memo obtained by NBC News showed that the modified G2 device had similar, potentially fatal flaws, as its predecessor. The memo was drafted just four months after the Food and Drug Administration (FDA) cleared the G2 for marketing.

Another document obtained by NBC News reported that the G2 device was linked to even more problems than IVC filters made by other medical device manufacturers.

Despite these dire reports, C.R. Bard decided to keep the G2 – as well as its virtually similar G2 Express Filter – on the market for five years, until 2010. During that time, more than 160,000 G2 filters were sold and implanted into patients. When NBC News published its story in 2015, at least a dozen deaths were linked to the G2.

In pretrial filings leading up to Booker’s trial, C.R. Bard attempted to exclude evidence of complications associated with its device, but the court ruled that the plaintiff could introduce information about the Recovery IVC Filter, finding that C.R. Bard had developed the G2 IVC Filter with the goal of reducing the number of fractures and migrations that had occurred with the Recovery device.

“All of the data that we’ve seen in our own studies, as well as other clinician researchers’, is that this device consistently fractures, consistently causes major complications,” Dr. William Kuo, an interventional radiologist with Stanford Health Care’s IVC Filter Clinic, told NBC News in 2015. The clinic specializes in removing failed blood clot filters. “The number of complications, the frequency of severe failures makes it obvious that it was never safe to be implanted.”

Sources:
U.S. District Court for the District of Arizona
Righting Injustice
NBC News



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