Bookerv. C. R. Bard, Inc. (In re Bard IVC Filters Prod. Liab. Litig.)

969 F.3d 1067

IN RE BARD IVC FILTERS PRODUCT LIABILITY LITIGATION,

Sherr-Una Booker, Plaintiff-Appellee,

v.C. R. Bard, Inc., a New Jersey corporation; Bard Peripheral Vascular, Inc., a subsidiary and/or Division of defendant C.R. Bard, Inc., an Arizona corporation, Defendants-Appellants.

No. 18-16349

United States Court of Appeals, Ninth Circuit.

Argued and Submitted February 3, 2020 Phoenix, Arizona

Filed August 13, 2020

James C. Martin (argued), Michael K. Brown, and Kasey J. Curtis, Reed Smith LLP, Los Angeles, California; Richard B. North Jr., Nelson Mullins Riley & Scarborough LLP, Atlanta, Georgia; for Defendants-Appellants.

David C. Frederick (argued), Brendan J. Crimmins, and Collin R. White, Kellogg Hansen Todd Figel & Frederick P.L.L.C., Washington, D.C.; Ramon Rossi Lopez and Joshua Mankoff, Lopez McHugh LLP, Newport Beach, California; Julia Reed Zaic, Heaviside Reed Zaic, Laguna Beach, California; for Plaintiff-Appellee.

Chilton Davis Varner and J. Franklin Sacha Jr., King & Spalding LLP, Atlanta, Georgia, for Amicus Curiae Product Liability Advisory Council Inc.

Robert S. Peck, Center for Constitutional Litigation P.C., Washington, D.C.; Elise Sanguinetti, President, American Association for Justice, Washington, D.C.; for Amicus Curiae American Association for Justice.

Before: Susan P. Graber, Andrew D. Hurwitz, and Eric D. Miller, Circuit Judges.

MILLER, Circuit Judge:

Sherr-Una Booker sued C. R. Bard, Inc. and Bard Peripheral Vascular, Inc. (collectively, "Bard"), asserting product-liability claims based on injuries she 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 argues 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. We affirm.

I

For more than a century, the Food and Drug Administration has been responsible for approving new drugs before they enter the market. See 21 U.S.C. § 301 et seq. Until 1976, however, medical devices were not subject to FDA regulation. In the Medical Device Amendments of 1976 (MDA), Pub. L. No. 94-295, 90 Stat. 539, Congress provided for FDA regulation of medical devices.

The MDA directs the FDA to divide medical devices into three classes based on the level of risk they present, and it provides for different regulation of each class. 21 U.S.C. § 360c(a)(1). Class I, the lowest-risk category, comprises products such as bandages and tongue depressors. Class I devices are subject to "general controls" such as labeling requirements. Id. § 360c(a)(1)(A). Class II devices are those for which general controls "are insufficient to provide reasonable assurance of ... safety and effectiveness." Id. § 360c(a)(1)(B). In addition to being subject to general controls, Class II devices are subject to "special controls" such as "performance standards, postmarket surveillance, ... recommendations, and other appropriate actions as the [FDA] deems necessary" to ensure safety and effectiveness. Id. Class III devices, the highest-risk category, are devices that cannot be determined to provide a "reasonable assurance of ... safety and effectiveness" under Class I or II controls, and that either are marketed as life-supporting devices or pose an unreasonable risk of illness or injury. Id. § 360c(a)(1)(C).

Class III devices are generally subject to premarket approval by the FDA. 21 U.S.C. § 360e. Premarket approval is a rigorous process that requires the manufacturer to submit a detailed application including studies of the device's safety and effectiveness. See id. § 360e(c)(1) ; Riegel v. Medtronic, Inc. , 552 U.S. 312, 317–18, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). The FDA may approve the device only if has "reasonable assurance" that the device is safe and effective. 21 U.S.C. § 360e(d)(2)(A)–(B).

By contrast, Class I and II devices are generally subject to a far less rigorous process referred to as section "510(k) approval," Riegel , 552 U.S. at 322, 128 S.Ct. 999, which requires the manufacturer to show only that the device is "substantially equivalent" to an existing Class I or Class II device. 21 U.S.C. § 360c(f)(1)(A)(ii) ; see Medtronic, Inc. v. Lohr , 518 U.S. 470, 478–79, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). To grant approval, the FDA must find that the device "has the same technological characteristics as the predicate device," or, if the device has different technological characteristics, that it "is as safe and effective as a legally marketed device, and ... does not raise different questions of safety and effectiveness than the predicate device." 21 U.S.C. § 360c(i)(1)(A).

This case involves an "intravascular filter," 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. (To visualize the filter, imagine the frame of an umbrella turned inside out by the wind. The spokes of the umbrella have small hooks that hold the structure in place on the walls of the vein.)

Until 2000, intravascular filters were regulated as Class III devices. In that year, the FDA issued a final rule reclassifying them as Class II devices and adopting three "special controls." 21 C.F.R. § 870.3375(b) ; see Medical Devices; Reclassification of 28 Preamendments Class III Devices into Class II, 65 Fed. Reg. 17,138, 17,144 (Mar. 31, 2000). The first special control is the "Use of International Standards Organization's ISO 10993 ‘Biological Evaluation of Medical Devices Part I: Evaluation and Testing,’ " 21 C.F.R. § 870.3375(b)(1), which relates to biocompatibility and seeks to reduce "potential adverse tissue reactions" associated with "devices that contact the body." Medical Devices; Reclassification of 38 Preamendments Class III Devices into Class II, 64 Fed. Reg. 12,774, 12,777 (Mar. 15, 1999). The second special control is the "510(k) Sterility Review Guidance and Revision of 2/12/90 (K90-1)," 21 C.F.R. § 870.3375(b)(2)(i), which relates to sterilization and sets out "information about the use and application of national and international sterility consensus standards for devices to be labeled as ‘sterile’ " so as to reduce "[t]he potential risk of infection." 64 Fed. Reg. at 12,777. The third special control is the "Guidance for Cardiovascular Intravascular Filter 510(k) Submissions," 21 C.F.R. § 870.3375(b)(2)(ii), which sets forth certain "labeling, biocompatibility testing, mechanical testing, sterilization procedures and labeling, and clinical data controls" related to intravascular filters, 64 Fed. Reg. at 12,778.

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, Booker's physician implanted a G2 filter in her inferior vena cava. Several years later, after Booker began to experience severe pain, an examination revealed that the filter had fractured and perforated her inferior vena cava. She 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.

Booker brought this action against Bard in the District of Arizona as part of a multidistrict litigation involving thousands of similar cases. Booker is a resident of Georgia, and she asserted design-defect and failure-to-warn claims under Georgia law, which the parties agree governs this case.

Bard filed an omnibus motion for summary judgment for all cases in the multidistrict litigation, arguing that the MDA preempted all state-law claims. Bard relied in part on the MDA's express preemption clause, which 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 district court denied the motion, reasoning that the MDA preempts state law only when the FDA has established "device-specific requirements," and concluding that the agency had not done so here.

After Booker's case was selected for trial, Bard filed a motion for partial summary judgment on all of Booker's claims, apart from the design-defect claims. As relevant here, Bard argued that Booker's failure-to-warn claims were contrary to Georgia law. According to Bard, Georgia imposes on manufacturers a duty to warn of the risks posed by their products but does not impose a duty to warn about how...