In its opinion filed on August 13, 2020, the United States Court of Appeals for the Ninth Circuit (“Federal Appellate Court”) affirmed a federal jury’s verdict against C. R. Bard, Inc. and Bard Peripheral Vascular, Inc. (collectively, “Bard”) involving product-liability claims based on injuries the plaintiff sustained from a medical device designed and manufactured by Bard. The jury found Bard liable for negligent failure to warn, awarding $1.6 million in compensatory damages and $2 million in punitive damages.
On appeal, Bard argued that the district court erred by denying summary judgment on its preemption defense, that a failure-to-warn claim is unavailable in these circumstances, and that the award of punitive damages was not supported by the evidence.
Bard’s G2 Intravascular Filter
An intravascular filter is a device used in patients who have, or are at risk of developing, blood clots in the veins in their legs. Such clots can migrate to arteries in the lungs, causing a pulmonary embolism, a potentially life-threatening condition. Physicians can prescribe medications to inhibit clotting and prevent the formation of blood clots. But not all patients are able to use such medications. For those patients, physicians may prescribe an intravascular filter, which is implanted in the inferior vena cava, a large vein through which blood returns to the heart from the lower body. There, the filter can intercept clots before they travel to the lungs.
Bard manufactures several different intravascular filters, including the G2 Filter, which received section 510(k) approval in 2005. Bard distributed the G2 Filter with a label addressing various potential complications, including “fracture” (the filter breaks into pieces), “migration” (the filter moves from where the physician implanted it), and “perforation” (the filter, or fragments of the filter, punctures the wall of the vein).
After it began selling the G2 Filter, Bard received reports of complications associated with the filter and conducted various internal analyses to review those risks. Its analysis revealed that the G2 Filter’s rates of fracture, migration, and perforation were significantly higher than those of other competing filters. Bard did not include that information in the product’s labeling.
In 2007, the plaintiff’s physician implanted a G2 filter in her inferior vena cava. Several years later, after she began to experience severe pain, an examination revealed that the filter had fractured and perforated her inferior vena cava. The plaintiff underwent two surgeries to attempt to remove the filter and its fractured pieces, but the surgeries were only partially successful, and one piece of the filter remains embedded in the wall of her inferior vena cava.
The plaintiff sued Bard in the District of Arizona as part of a multidistrict litigation involving thousands of similar cases. The plaintiff is a resident of Georgia, and she asserted design-defect and failure-to-warn claims under Georgia law, which the parties agreed governs this case.
Federal Appellate Court Opinion
The Federal Appellate Court stated that Bard’s preemption argument fails because the plaintiff’s claim rests on an asserted state-law duty to warn of the risks posed by the particular design of Bard’s G2 Filter, and the FDA has not imposed any requirements related to the design of that device or how a device of that design should be labeled.
The Federal Appellate Court further stated that Georgia has not adopted a categorical prohibition on basing a failure-to-warn claim on the absence of a comparative warning, and other federal courts applying Georgia law have allowed such claims. “Consistent with those decisions, we conclude that the district court correctly allowed the jury to decide the adequacy of the warning here.”
The Federal Appellate Court concluded that Bard’s challenge to the punitive damages award is largely derivative of its argument that it had no duty to warn of comparative risks. “In Bard’s view, punitive damages are inappropriate because it sold a product that was “not defective and sold with an adequate warning.” But the jury found that the warning was not adequate. As the district court explained, “[t]he evidence supported a finding that despite knowing that G2 filters placed patients at a greater risk of harm” than other available filters, “Bard chose not to warn physicians and instead downplayed the risk.” Although it would have been possible for the jury “to draw a contrary conclusion,” we conclude that the evidence was adequate to support the jury’s award of punitive damages.”
Source In Re Bard IVC Filters Product Liability Litigation, Booker v. C.R. Bard, Inc., No. 18-16349.
If you or a loved one were seriously injured (or worse) due to a Bard IVC filter, you should promptly find a defective medical device claim lawyer who may investigate your IVC filter claim for you or your loved one and represent you or your loved one in a claim for compensation due to the harm suffered as a result of a defective IVC filter, if appropriate.
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