Booker v. C.R. Bard, Inc., No. 18-16349 (9th Cir. 2020)
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The Ninth Circuit affirmed the district court's judgment for plaintiff in an action alleging product-liability claims based on injuries she sustained from a medical device -- the G2 intravascular filter -- 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.
The panel held that, because Bard's preemption defense presented a purely legal question, it would consider the merits of the district court's denial of its motion for summary judgment. The panel held that the preemption argument fails because Booker'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. In regard to the failure-to-warn claim, the panel held that Georgia courts had not adopted a categorical prohibition on basing a failure-to-warn claim on the absence of a comparative warning, and the district court correctly allowed the jury to decide the adequacy of the warning. Finally, the panel held that the evidence was adequate to support the jury's award of punitive damages.
Court Description: Preemption / Medical Devices. The panel affirmed the district court’s judgment in favor of a plaintiff who brought product-liability claims based on injuries she sustained from a medical device designed and manufactured by C.R. Bard, Inc. Plaintiff brought this action in the District of Arizona as part of a multidistrict litigation, asserting claims under Georgia law. Bard filed an omnibus motion for summary judgment for all cases in the multidistrict litigation, arguing that the federal Medical Device Amendments of 1976 preempted all state-law claims. The case involved Bard’s G2 Filter – an “intravascular filter” that the Food and Drug Administration (“FDA”) reclassified as a Class II device with three “special controls.” The panel held that, because Bard’s preemption defense presented a purely legal question, the panel would consider the merits of the district court’s denial of its motion for summary judgment. The panel held that Bard’s preemption IN RE BARD IVC FILTERS PRODS. LIAB. LITIG. 3 argument failed because plaintiff’s claim rested on an asserted state-law duty to warn of the risks posed by the particular design of Bard’s G2 Filter, and the FDA had not imposed any requirements related to the design of that device or how a device of that design should be labeled. Bard next argued that the district court erred in denying summary judgment on plaintiff’s negligent failure-to-warn claim because Georgia law did not recognize a duty to warn of the comparative risks posed by different products. The panel held that Georgia courts had not adopted a categorical prohibition on basing a failure-to-warn claim on the absence of a comparative warning. The panel concluded that the district court correctly allowed a jury to decide the adequacy of the warning here. Bard argued that the district court erred by denying its renewed motion for judgment as a matter of law, which challenged the evidentiary sufficiency for the punitive damages award. The panel held that Bard’s challenge to the punitive damages award was largely derivative of its argument that it had no duty to warn of comparative risks. The panel concluded that the evidence was adequate to support the jury’s award of punitive damages.
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