When Sherr-Una Booker’s physician chose and implanted a Bard G2 IVC filter following into her body in 2007, he was unaware that the device’s manufacturer was already aware of problems with the device, including ten instances of the product migrating within patients’ bodies just months after release onto the market.
The same thing ended happening to Booker, leaving her with the fractured filter penetrating her inferior vena cava and embedded in her right atrium. In 2014 she had surgery to repair the damage and remove the broken parts, but her surgeons found that some pieces could not be removed, while the removal of others led to a damaged tricuspid valve that needed another surgery. In 2016 she sued Bard, the device’s manufacturer, and a jury awarded her a total of $3.6 million in compensatory damages and punitive damages.
Following this decision, the IVC filter manufacturer returned to court, appealing the judgment and arguing that the evidence submitted about their device did not support the jury’s decision, but the judge in the case decided against the company, saying that the case had been proven.
In writing on his decision, Judge David Campbell of the U.S. District Court for Arizona, said, “Plaintiff presented sufficient evidence for the jury reasonably to find that the G2 filter failed at higher rates than other filters, including Bard’s own Simon Nitinol Filter, and that Bard failed to warn plaintiff’s treating physicians about these higher rates.”
Judge Campbell pointed to the ten cases of filter migration that Bard had known about within two months of their product’s release, as well as a statement made by one of the company’s own engineers saying that “the design features of the G2 made it less resistant to caudal migration, and this complication could lead to tilting, perforation, and fracture.” The judge went on to say,“There was also evidence that Bard failed to warn physicians about the G2 filter’s higher complication rates, and that physicians generally would want to know this information when making treatment decisions.”
Booker’s physician also provided testimony indicating that there were other options available and that he would have pursued a different device had warnings been provided about the risks involved with using the Bard G2 model.