Testimony has concluded in the nation’s latest trial involving C.R. Bard, Inc.’s allegedly defective retrievable IVC filters.
The case is the third bellwether trial convened in the U.S. District Court, District of Arizona, where federally-filed IVC filter lawsuits involving Bard’s devices have been consolidated for coordinated pretrial proceedings.
The verdict in this closely-watched test case could provide insight into how other juries might rule in similar claims involving Bard’s retrievable blood clot filters.
The plaintiff selected for this case, Lisa Hyde, received Bard’s retrievable G2X IVC filter in 2011. According to her complaint, the device fractured, migrated, and perforated her heart three years after its implantation, resulting in its removal in 2014. (Case No. 2:15-cv-10030)
On Tuesday, the judge overseeing the trial granted a defense motion to dismiss Hyde’s claim for damages for future injuries and costs from related to cardiac arrhythmia, which she asserts might at some point result from her IVC filter complications.
During trial, an expert witness testifying on Hyde’s behalf told the jury that she should be monitored for arrhythmia and might need a cardiac defibrillator at some point in the future.
However, the judge ruled that Wisconsin law “holds that future injuries and medical care must be established by a medical probability, not a mere possibility.” Hyde received her IVC filter in Wisconsin.
“This testimony is not sufficient under Wisconsin law to support an award of damages for the cost of a defibrillator or any other medical costs or injuries associated with future cardiac arrhythmia,” the judge wrote.
C.R. Bard had sought to have the lawsuit’s claims of design defect, punitive damages, and loss of consortium for her husband, dismissed as well. However, the judge rejected those motions.
More than 4,880 IVC filter lawsuits involving Bard’s devices have been centralized in the District of Arizona. All of the lawsuits were filed on behalf of individuals who suffered serious injuries and complications following the malfunction of the company’s blood clot filters, including Recovery, G2, G2 Express, G2X, Eclipse, Meridian, and Denali devices.
In March, the jury convened to hear the litigation’s first bellwether trial found that Bard was negligent for failing to warn doctors about the risks potentially associated with the G2 IVC filter. The plaintiff in that case was awarded $1.6 million in actual damages and $2 million in punitive damages.
The litigation’s second bellwether trial – involving Bard’s Eclipse IVC Filter – concluded in May, with a win for the defense.
An IVC filter lawsuit initially selected for the litigation’s third bellwether trial was dismissed in August, after Bard won a motion for summary judgement.
IVC filters are indicated for use in patients at risk for pulmonary embolism, but who are unable to use standard blood-thinning medications.
Once implanted into the inferior vena cava, the small, wire cage-like devices catch blood clots that have broken loose from other parts of the body and prevents them from travelling to the heart and lungs. The IVC filters at the center of the Bard litigation are intended to be removed once a patient is out of danger. However, studies have suggested that retrievable blood clot filters are often allowed to remain in place long after any medical need has passed.
In 2010, the U.S. Food & Drug Administration (FDA) reported that it had received over 900 reports of injuries and complications associated with the use of IVC filters, including migration, embolization, perforations of the inferior vena cava, and filter fractures.
Just 4 years later, the FDA issued a second alert stressing the importance of retrieving temporary IVC filters within 29 to 54 days implantation, so as to reduce the risk of patient harm.