On Friday, March 30, an Arizona Federal Court jury returned a 3.6-million-dollar verdict for plaintiff Sherri Booker in the first Bard IVC filter bellwether case. The verdict included $1.6 million in compensatory damages plus $2 million in punitive damages. This trial was led by Ramon Lopez and Mark O’Connor, and it was a terrific team effort with the Plaintiffs’ Steering Committee. Federal Judge David Campbell presided over this trial.
What Is an IVC Filter?
An IVC filter is designed to be placed into the inferior vena cava veins of people who cannot take blood thinners. The filter is supposed to “catch” blood clots before they can reach the heart. The defense, led by Richard North of Nelson Mullins, argued IVC filters are life-saving devices.
What’s the Problem?
Bard (and other manufacturers such as Cook and Cordis) all created a line of “permanent and retrievable filters,” which were approved under the FDA 510k exception and never underwent any human trials. We proved Bard knew these filters had a big problem – they did not stay in place like the predicate devices. Instead, these filters tilt more often, which causes them to perforate and migrate. Pieces of the device can fracture, pierce the vein and even travel to the heart or lungs. There are hundreds of thousands of filters still in patients today.
Why Did the Jury Award Punitive Damages Against Bard?
Punitive damages are intended to punish a company when they show reprehensible conduct or conscious indifference to the rights and safety of others. The jury found Bard engaged in this type of conduct.
Bard’s original FDA-approved filter was called the Simon Nitinol filter. To expand the market, Bard came up with a new design and obtained FDA 510k clearance (not FDA approval – which would have required human trials). Bard immediately began experiencing deaths, perforations, migrations, and fractures. But rather than determine a root cause of the failures, Bard simply did what we call a “silent recall.” In other words, they redesigned the device and began selling the new models without withdrawing the old ones. Bard never communicated these problems to the doctors or the patients. Nor did they tell doctors to monitor the filters to watch for tilting, migration, perforation, or fracture. They just left the dangerous devices on the market and allowed them to continue to be put in unsuspecting patients.
On top of that, even the redesigned models still caused the filters to tilt, perforate, and fracture. The new designs were causing many more problems than the FDA-approved filters. Meanwhile, Bard was making hundreds of millions of dollars and continuing to claim the new filters were substantially equivalent to the FDA approved filters when their own documents showed the opposite.
We argued these implanted filters were just time bombs waiting to go off. Many filters cannot be removed. Bard failed to warn of the dangers they knew about. There was testimony that had Plaintiff and her doctor known about these risks, they would never have used the Bard filter. The jury agreed Bard’s conduct was reprehensible and awarded 2 million dollars in punitive damages.
What Are the Injuries?
Ms. Booker was 37 when she received a Bard G2 Filter that tilted, migrated, perforated, and eventually fractured. Pieces of the filter traveled to her heart, and she had to have open heart surgery to save her life. She is a wonderful lady, and it is an honor for our team to help her recover for the injustice she has experienced.
When Is the Next Trial?
There are 3,600 other plaintiffs in this MDL. Our firm is privileged to have been appointed to the Plaintiffs’ Steering Committee with the fine attorneys who all contributed to this result. The next bellwether trial is expected to start May 15th in the same Court.
When Will This Litigation Be Resolved?
We honestly cannot predict that. The purpose of bellwether trials is to provide the parties with some understanding of what would happen if more trials occurred. Winning at these trials is very important to convince Bard that they need to be accountable for their behavior. Many times it takes a number of these trials before the parties can sit down and resolve all the cases. There are other bellwether trials scheduled in both Federal and State Court this year. We will continue to provide updates.