Product News and Recalls

Georgia Bellwether IVC Filter Case Results in Win for Bard

bard wins Georgia ivc filter caseAs over 3,000 Bard IVC filter failure lawsuits await trial, one of the cases chosen as a model and indicator for the direction of the others has resulted in a defeat for the plaintiff. Savannah, Georgia resident Doris Jones’ case was, along with four others, to serve as a bellwether trial to help both sides determine proper terms for a settlement. And while the first case in that series resulted in a multi-million-dollar decision for the plaintiff after less than six hours of jury deliberation, Jones would walk away from her trial with nothing.

Jones’ lawyer believes the losing verdict is related to what the jury was; but perhaps more importantly, was not allowed to hear during the case. “Unfortunately,” he says, “we believe the Court made mistakes in what evidence we allowed the jury to hear, and believe if he had ruled differently the outcome would have been different as well.”

Those differences may indeed have been key, as they related to information that detailed the extent to which the Bard IVC filter implanted in Ms. Jones had been tested before being released to the public.

This is because the filter in question had never been tested in humans and didn’t actually carry a full FDA “approval.” Instead, it had only attained the level of FDA “clearance.” In one case, the device in question has undergone the FDA’s most rigorous checks and vetting. In the other, the company needs only to prove that the device is very similar to another device that already has FDA approval and, as a result, makes human trials unnecessary. Ms. Jones’ model of filter – and presumably that of thousands of other potential victims – had only undergone the FDA “clearance” process.

As a result, Jones and her lawyer assert that she was the human trial and paid the penalty for it. As it turns out, she actually may have been unwittingly testing the redesign of a device that had taken lives in the past. Five years prior to Jones’ case, previous versions of her IVC filter were found by Bard themselves to have caused fatal injuries in patients implanted with the device.

This evidence was allowed in the previous bellwether case and the jury in that case awarded the victim $4 million. It was not allowed in the Jones case and the jury ruled in Bard’s favor. Jones and her lawyer plan an appeal of her case to the 9th Circuit Court of Appeals – the last step before the halls of the United States Supreme Court.