Medical device manufacturer C.R. Bard won’t be able to shake the $3.6 million jury verdict from the first test trial in the multidistrict litigation (MDL) over the safety of its blood clot filters. An Arizona federal court flatly denied Bard’s IVC filter appeal as a matter of law Tuesday.
In April, Bard argued that the evidence supporting the award was insubstantial and called the verdict “irreconcilably inconsistent,” as the jury found for plaintiff Sherri Booker on a negligent failure to warn claim but discounted a practically identically strict liability failure to warn claim.
Despite these assertions, District Judge David G. Campbell entered the IVC filter appeal denial order Tuesday, discounting Bard’s arguments as erroneous. According to Judge Campbell, not only did the jury have plenty of evidence to support its verdict, the two claims in questions are clearly distinguishable. Consequently, the jury was well within its rights to treat them as such, finding liability for one and not the other.
“The court denied defendants’ initial request for judgment as a matter of law during trial, and denied their earlier motion for summary judgment,” Judge Campbell said. “The court continues to conclude that there is sufficient evidence to support a finding in favor of plaintiff.”
IVC Filter Appeal Background
Booker was 37 when she received a Bard G2 filter in her inferior vena cava (IVC), the body’s largest vein. The spider-like filter broke apart in 2009, causing fragments to lodge in Booker’s heart and spine. Consequently, Booker had to undergo open heart surgery to remove the metal shards. However, according to court documents, several pieces remain and continue to cause substantial complications.
Booker was the first plaintiff in the approximately 3,700 strong MDL over serious health issues from Bard’s IVC filters to face off against the medical device maker. Her bellwether trial and the other test trials that will pass through the federal court will help give attorneys on both sides a sense of the relative strengths and weaknesses of their individual cases throughout the MDL to guide all parties toward a potential IVC filter settlement agreement.
At the conclusion of Booker’s trial, the jury found Bard liable for negligently failing to warn the doctor who implanted Booker with the G2 filter about the device’s serious risk factors. The overall award was $4 million, split evenly between compensatory and punitive damages. However, roughly $400,000 of that falls on the shoulders of a radiologist who missed obvious signs that the G2 filter was starting to fracture when he X-rayed Booker earlier in 2009.
IVC Filter Appeal
In its IVC filter appeal, Bard argued that Booker failed to show that the G2 filter’s risks were much higher than any other blood clot filter. However, Judge Campbell countered that ““one of Bard’s leading design engineers testified that the design features of the G2 made it less resistant to caudal migration and this complication could lead to tilting, perforation, and fracture.”
In this case, caudal migration refers to when the IVC filter is sucked toward the heart. This movement can cause the filter to turn and break up inside of the vein.
Furthermore, Judge Campbell also noted internal studies that concluded the G2 filter had a greater risk of caudal migration than other filters. This includes its predecessor at Bard. But, Bard failed to disclose this information to the medical community. On this point, Judge Campbell quoted Booker’s doctor.
“Would I have used a different device if I knew at the time that the Bard filter was not ideal or as good as some of the other implants?” her doctor testified. “The answer would have to be yes.”
IVC Filter Appeal Precedent
In terms of Bard’s assertions about inconsistencies in the jury’s verdict, Judge Campbell said they were too little, too late. Judge Campbell ruled Bard had ample opportunities to clarify jury instructions before and during the trial. Furthermore, precedent dictates that the jury can issue seemingly inconsistent verdicts on closely related claims, as long as they are not dependent upon each other. Judge Campbell admitted that “the verdicts in this case are not without tension.” Nonetheless, he concluded that “they can be harmonized.”
“’The focus in negligence is on the manufacturer’s conduct, while in strict liability it is on the product and the user’s expectations,’” Judge Campbell quoted from the Ninth Circuit’s 1987 decision in Toner v. Lederle Labs.
Therefore, the negligent to warn claim focused on “whether Bard breached its duty of reasonable care to plaintiff by failing to provide adequate warnings about the G2 filter,” while the strict liability failure to warn claim “focused on the adequacy of the warning given with the G2 filter at the time of sale.”
“Thus, the jury could have found, consistent with the instructions and the evidence, that the warning provided with the G2 filter when it was sold was not inadequate, but that Bard was negligent in failing to warn about later-acquired information,” Judge Campbell said.