Health Law Daily Intravascular filter manufacturer on the hook for $2 million punitive damages
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Friday, August 14, 2020

Intravascular filter manufacturer on the hook for $2 million punitive damages

By Leah S. Poniatowski, J.D.

Jury’s findings of inadequate warnings supported by evidence, and state law was distinct from regulations to escape preemption.

A manufacturer of intravascular filters could not escape a jury award for $1.6 million in compensatory damages and an additional $2 million in punitive damages because federal preemption did not apply, Georgia recognizes a failure to warn of risks as compared to competing products, and there was sufficient evidence to support the jury’s finding that punitive damages were merited, the U.S. Court of Appeals for the Ninth Circuit ruled, affirming the lower court (In re Bard IVC Filters Product Liability Litigation, August 13, 2020, Miller, E.).

Background. A patient had a C. R. Bard G2 Filter implanted in 2007. She began to experience severe pain several years later, and an examination showed that the device had fractured, perforating her inferior vena cava. Despite undergoing two procedures to remove the pieces, one could not be removed from the wall of her inferior vena cava. She filed a products liability lawsuit against Bard and Bard Peripheral Vascular, Inc., for negligent failure to warn, joining others in a multi-district litigation.

Bard filed an omnibus motion for summary judgment on the basis that all the claims were preempted by the federal Medical Device Amendments of 1976 (MDA), Pub. L. No. 94-295, 90 Stat. 539, to the federal Food and Drug Act, 21 U.S.C. § 301 et seq. The MDA provides an express preemption clause, which states that the legislation preempts any state “requirement . . . which is different from, or in addition to, any requirement applicable under this chapter to the device, and . . . which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter." 21 U.S.C. § 360k(a). The motion was denied on the reasoning that the preemption applied only when the FDA has established “device-specific requirements," which did not apply to the filter.

Trial court. The patient’s case was selected for trial. Bard filed a motion for partial summary judgment on all but the design-defect claims. Specifically, it argued that the failure-to-warn claims were against Georgia law because Georgia’s legal requirement that manufacturers warn of risks posed by a product did not impose a duty to warn about how those risks compare to those of competing products. The trial court disagreed with Bard’s interpretation of Georgia law, holding that it was a question for the jury whether the warning was adequate.

The jury returned a verdict in favor of the patient, finding Bard liable for negligent failure to warn. In addition to awarding the patient $1.6 million in compensatory damages, the jury awarded $2 million in punitive damages. Bard unsuccessfully challenged the sufficiency of the evidence to support the punitive damages award, filing the present appeal.

Purely legal issues. The appellate court, as an initial matter, determined that purely legal issues are reviewable after trial, even if raised in a motion for summary judgment, despite the general rule of non-reviewability. The preemption issued raised by Bard presents a purely legal question.

Preemption. The appellate court explained that it is guided by regulation as to how to interpret the preemption provision in the MDA. Under 21 C.F.R. § 808.1(d), the statute’s preemptive scope applies only when the FDA has established “specific requirements applicable to a particular device under the [MDA], thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific [FDA] requirements." The U.S. Supreme Court also interpreted the MDA and the regulation in two decisions, holding that the preemption provision applies when there are specific FDA requirements applicable to a particular device, and section 510(k) approval is not, in itself, a specific requirement.

Reclassification of device. The filters at issues had originally been classified as a Class III medical device, subject to the rigorous premarket approval process as it presents higher risks than other categories. In 2000, the FDA reclassified the devices as Class II and adopted three special controls pertaining to biocompatibility, sterility and similar aspects to ensure the safety of the devices. Bard argued that those special controls were “specific requirements applicable to a particular device" per the regulation. The appellate court disagreed that the controls were "specific requirements."

The appellate court stated that "we assume, without deciding, that the special controls are requirements, but we nevertheless conclude that they are not ‘specific’ requirements ‘applicable to a particular device’ under" the regulation. Reviewing the special controls documents revealed that they were not sufficiently specific, thus reflecting "generic concerns" about the device, and the guidance targeting intravascular filters applied to every member of the class of those filters. Additionally, the requirements in the guidance were not relevant to the patient’s claim. Accordingly, the state law governing product warning labels was not relevant to the FDA’s requirements.

The patient claimed that the filter’s label failed to warn that it had a greater risk of migration and perforation as compared to other filters. The regulation did not provide any guidance with respect to labeling risk compared to competing products. Because the FDA did not impose a requirement on how the device should be designed or how it should be labeled, Georgia’s duty to warn law did not present any conflict to trigger preemption.

Comparative risks. Bard asserted that the lower court erred when it granted the patient’s motion for summary judgment because Georgia does not recognize a duty to warn of the comparative risks posed by different products. Bard relied on non-Georgia precedent, which the appellate court rejected, explaining that it was obliged to determine what rule courts in the state would apply. Georgia’s high court held that manufacturers have a duty to warn of dangers presented by their products, and that the sufficiency of the warning is a question for the jury. The appellate court observed that other federal courts in the state have allowed failure-to-warn claims based on the absence of a comparative warning. Consequently, the lower court did not err when it allowed the jury to determine whether the warning was adequate.

Sufficient evidence. The appellate court also agreed with the lower court that the evidence presented was sufficient to support the punitive damages award. Governing precedent held that punitive damages are generally improper when a manufacturer adhered to safety regulations, but punitive damages may be awarded if there is evidence showing culpable behavior "notwithstanding the compliance with applicable safety regulations." The jury found that the warning was inadequate, and the lower court determined that the manufacturer chose not to warn physicians and downplayed the greater risk their filters presented to patients. The appellate court, thus, upheld the jury’s finding, affirming the lower court.

The case is No.: 18-16349.

Attorneys: Robert D. Roll (Watkins, Lourie, Roll & Chance, PC) for Sherr-Una Booker. James R. Condo (Snell & Wilmer L.L.P.) for C. R. Bard, Inc. and Bard Peripheral Vascular, Inc.

Companies: C. R. Bard, Inc.; Bard Peripheral Vascular, Inc.

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