A federal judge has denied motions by medical device manufacturer C. R. Bard, Inc. that would have reversed a recent $3.6 million verdict against the company in the first trial to explore issues common to more than 3,800 IVC filter lawsuits consolidated in multidistrict litigation in the U.S. District Court of Arizona.
IVC filters are placed in the inferior vena cava (IVC), the largest vein carrying blood from the lower body back to the heart, to catch blood clots and prevent them from traveling to the heart and lungs. But they have a history of fracturing, piercing the IVC and migrating to the heart, resulting in damage to multiple organs and, at times, death. Many, including the U.S. Food and Drug Administration, have questioned whether the possible benefits of filter placement are worth the risks.
The plaintiff in the case, Sherr-Una Booker, was implanted with a Bard G2 IVC filter ten years ago. The filter subsequently fractured, perforating her IVC. Pieces of the filter migrated to her heart, where some remain despite open-heart surgery.
Jurors found that the fracturing of the G2 filter was responsible for 80% of Booker’s injuries. 20% were attributed to a radiologist who failed to notice the fracture early on, when further damage might have been prevented.
On March 30, Bard was ordered to pay $1.6 million in compensatory damages to the plaintiff and an additional $2 million in punitive damages. Judge David Campbell denied Bard’s request for “judgment as a matter of law” (a ruling that the evidence was not sufficient to justify the verdict), as well as its petition for a new trial.
Judge Rules Evidence Supports Bard IVC Filter Verdict
In multidistrict litigation, lawsuits with common issues of fact and law are transferred to one federal court for pretrial rulings and discovery. Several lawsuits are chosen for “bellwether” trials that allow both plaintiffs and defendants to see how jurors are likely to respond to evidence and arguments shared by all the cases.
At the center of all the Bard lawsuits is the question of whether Bard provided physicians with adequate warnings of the risk of serious injury resulting from the implantation of its filters. In pretrial motions and in his ruling following the verdict, Judge Campbell allowed the evidence to speak for itself.
Before the trial, Bard filed a motion for summary judgment, asking the court to dismiss Booker’s failure to warn claim. Bard argued that IVC filter migration, filter fracture and penetration of the IVC wall were all mentioned in the G2 Instructions for Use (“IFU”), and that physicians were generally aware of these dangers.
In his summary judgment order Judge Campbell rejected these arguments. First, he noted that the IFU warnings were “limited in scope.” Sections of the IFU entered into the judge’s order suggest that filter migration was primarily the result of “improper deployment.”
By speaking in generalities (e.g., “Filter fracture is a known complication of vena cava filters.”), the IFU implied that various IVC filter complications are common to all filters equally. Bard used similar tactics in its motion for summary judgment, stating that IVC filter complications were well known to medical doctors.
“But this argument,” said Judge Campbell, “misses the mark.” The plaintiff, he noted, “presents evidence that the G2 filter involved substantially greater risks of failure than competitor filters and even Bard’s own SNF filter….” It was “for the jury to decide” whether a manufacturer had provided a full disclosure of the risk involved, the judge concluded.
Similar reasoning prevailed in Judge Campbell’s dismissal of Bard’s requests for judgment as a matter of law and for a new trial. In denying Bard’s motions the judge reviewed the evidence against Bard presented during the trial, including:
- 10 reports of IVC filter migration received by Bard shortly after the G2 entered the market.
- Internal documents showing the failure rate was probably higher than the 10 reports suggested.
- Testimony of a Bard engineer that the design of the G2 made it less resistant to complications that could lead to filter tilting, IVC perforation and fracture.
According to a report at massdevice.com, Judge Campbell wrote, “Plaintiff made clear that Bard should have warned physicians that the G2 filter failed at rates higher than other filters, and that its propensity to migrate caudally [against the blood flow, towards the groin] could lead to other complications such as tilt, perforation, and fracture.”
The judge also said the plaintiff had presented “substantial evidence” that Ms. Booker’s doctor was not aware of the increased risks associated with the G2 filter and would not have used the G2 if she had been fully informed of the dangers posed by the filter.
“The court denied defendants’ initial request for judgment as a matter of law during trial, and denied their earlier motion for summary judgment. The court continues to conclude that there is sufficient evidence to support a finding in favor of plaintiff.” — Judge David Campbell, U.S. District Court of Arizona
Judge Affirms Punitive Damages Award Against C.R. Bard
Ms. Booker’s original lawsuit was filed in Georgia, where she was living when her injuries occurred. For that reason, the decision as to whether punitive damages could be awarded was based on Georgia law. Under Georgia law, punitive damages can only be awarded “if it is shown by clear and convincing evidence that the defendant’s actions showed willful misconduct, malice, fraud, wantonness, oppression, or that entire want of care which would raise the presumption of conscious indifference to consequences.”
The plaintiff introduced evidence that Bard’s Recovery IVC filter, which preceded the G2, was known by the company to be dangerous and that Bard was aware that the G2 had many of the same problems—perforation of the vena cava, migration and filter fracture—that plagued the Recovery.
The plaintiff also alleged that Bard, instead of pulling its filters from the market or warning physicians about these dangers, kept silent and hired a public relations firm to help them deal with negative stories.
The jurors clearly found the evidence that Bard withheld critical information from physicians to be persuasive and felt that the punitive damages standard of Georgia law had been met.
Judge Campbell agreed. In upholding the jury’s verdict, he ruled punitive damages were justified. “The evidence,” he wrote, “supported a finding that despite knowing that G2 filters placed patients at a greater risk of harm, Bard chose not to warn physicians and instead downplayed the risk.”
The punishing first Bard IVC filter verdict will stand.
Booker’s case is Booker v. C.R. Bard Inc. et al., case number 2:16-cv-00474. The master complaint for the consolidated cases, In re: Bard IVC Filters Products Liability Litigation, case number 2:15-md-02641, is available online.
If you or someone you know has been injured by an IVC filter, please contact the IVC filter lawsuit team at Baum, Hedlund, Aristei & Goldman for a free case evaluation. Attorneys can be reached by calling us at 800-827-0087.