969 F.3d 1067 (9th Cir. 2020), 18-16349, In re Bard IVC Filters Product Liability Litigation

Docket Nº:18-16349
Citation:969 F.3d 1067
Opinion Judge:MILLER, Circuit Judge.
Party Name:IN RE BARD IVC FILTERS PRODUCT LIABILITY LITIGATION 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. Sherr-Una Booker, Plaintiff-Appellee,
Attorney: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 Hanse...
Judge Panel:Before: Susan P. Graber, Andrew D. Hurwitz, and Eric D. Miller, Circuit Judges.
Case Date:August 13, 2020
Court:United States Courts of Appeals, Court of Appeals for the Ninth Circuit

Page 1067

969 F.3d 1067 (9th Cir. 2020)

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

August 13, 2020

Argued and Submitted February 3, 2020 Phoenix, Arizona.

Appeal from the United States District Court for the District of Arizona Nos. 2:15-md-02641-DGC, 2:16-cv-00474-DGC David G. Campbell, District Judge, Presiding

Page 1068

[Copyrighted Material Omitted]

Page 1069

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.

SUMMARY

[*]

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 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.

Page 1070

OPINION

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

Page 1071

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.

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5 practice notes
  • Specter v. Texas Turbine Conversions, Inc., 012121 AKDC, 3:17-cv-00194-TMB
    • United States
    • Federal Cases United States District Courts 9th Circuit District of Alaska
    • January 21, 2021
    ...have expanded the doctrine, most commonly in the context of medical devices. E.g., In re Bard IVF Filters Prod. Liab. Litig., 969 F.3d 1067, 1076 (9th Cir. 2020) (“Under the learned-intermediary doctrine, the manufacturer of a prescription drug or medical device doe......
  • In re Bard IVC Filters Products Liability Litigation, 021121 AZDC, MDL 15-02641-PHX-DGC
    • United States
    • Federal Cases United States District Courts 9th Circuit District of Arizona
    • February 11, 2021
    ...11934, 11953. As noted, the Ninth Circuit affirmed the Court's preemption ruling. See Docs. 21555, 21632; In re Bard, 969 F.3d at 1072-76. 3. The Lehmann Report Privilege and Work Product The Court granted Defendants' motion for a protective order to preve......
  • In re Bard IVC Filters Products Liability Litigation, 020921 AZDC, MDL 15-02641-PHX-DGC
    • United States
    • Federal Cases United States District Courts 9th Circuit District of Arizona
    • February 9, 2021
    ...See Docs. 11934, 11953. The Ninth Circuit affirmed. Docs. 21555, 21632; see In re Bard IVC Filters Prods. Liab. Litig., 969 F.3d 1067 (9th Cir. 2020). The Ninth Circuit denied Defendants' petition for panel rehearing and rehearing en banc. See No. 18-16349, Doc. 2.&......
  • Going Viral − The Ten Worst Prescription Drug/Medical Device Decisions of 2020
    • United States
    • LexBlog United States
    • December 23, 2020
    ...lax pleading requirements, nothing is required. We made mincemeat of Mize here. In re Bard IVC Filters Products Liability Litigation, 969 F.3d 1067 (9th Cir. 2020) (“Booker”). Booker started out with such promise – that the defense could finally get a court to examine express preemption in ......
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3 cases
  • Specter v. Texas Turbine Conversions, Inc., 012121 AKDC, 3:17-cv-00194-TMB
    • United States
    • Federal Cases United States District Courts 9th Circuit District of Alaska
    • January 21, 2021
    ...have expanded the doctrine, most commonly in the context of medical devices. E.g., In re Bard IVF Filters Prod. Liab. Litig., 969 F.3d 1067, 1076 (9th Cir. 2020) (“Under the learned-intermediary doctrine, the manufacturer of a prescription drug or medical device doe......
  • In re Bard IVC Filters Products Liability Litigation, 021121 AZDC, MDL 15-02641-PHX-DGC
    • United States
    • Federal Cases United States District Courts 9th Circuit District of Arizona
    • February 11, 2021
    ...11934, 11953. As noted, the Ninth Circuit affirmed the Court's preemption ruling. See Docs. 21555, 21632; In re Bard, 969 F.3d at 1072-76. 3. The Lehmann Report Privilege and Work Product The Court granted Defendants' motion for a protective order to preve......
  • In re Bard IVC Filters Products Liability Litigation, 020921 AZDC, MDL 15-02641-PHX-DGC
    • United States
    • Federal Cases United States District Courts 9th Circuit District of Arizona
    • February 9, 2021
    ...See Docs. 11934, 11953. The Ninth Circuit affirmed. Docs. 21555, 21632; see In re Bard IVC Filters Prods. Liab. Litig., 969 F.3d 1067 (9th Cir. 2020). The Ninth Circuit denied Defendants' petition for panel rehearing and rehearing en banc. See No. 18-16349, Doc. 2.&......
2 firm's commentaries
  • Going Viral − The Ten Worst Prescription Drug/Medical Device Decisions of 2020
    • United States
    • LexBlog United States
    • December 23, 2020
    ...lax pleading requirements, nothing is required. We made mincemeat of Mize here. In re Bard IVC Filters Products Liability Litigation, 969 F.3d 1067 (9th Cir. 2020) (“Booker”). Booker started out with such promise – that the defense could finally get a court to examine express preemption in ......
  • Going Viral − The Ten Worst Prescription Drug/Medical Device Decisions Of 2020
    • United States
    • Mondaq United States
    • December 28, 2020
    ...lax pleading requirements, nothing is required. We made mincemeat of Mize here. In re Bard IVC Filters Products Liability Litigation, 969 F.3d 1067 (9th Cir. ("Booker"). Booker started out with such promise - that the defense could finally get a court to examine express preemption......