Supreme Court of the United States

No. 15-321 IN THE Supreme Court of the United States PATRICIA CAPLINGER, Petitioner, v. MEDTRONIC, INC. AND MEDTRONIC SOFAMOR DANEK USA, INC., Respondents. On Petition for a Writ of Certiorari to the United States Court of Appeals for the Tenth Circuit BRIEF OF AARP AND CONSUMERS UNION AS AMICI CURIAE SUPPORTING PETITIONER KELLY BAGBY MAAME GYAMFI AARP FOUNDATION LITIGATION, INC. 601 E Street, N.W. Washington, D.C. 20049 (202) 434-2103 EILEEN B. HERSHENOV Vice President & General Counsel CONSUMER REPORTS 101 Truman Avenue Yonkers, NY 10703 October 15, 2015 DAVID C. FREDERICK Counsel of Record MATTHEW R. HUPPERT KELLOGG, HUBER, HANSEN, TODD, EVANS & FIGEL, P.L.L.C. 1615 M Street, N.W. Suite 400 Washington, D.C. 20036 (202) 326-7900 (dfrederick@khhte.com) GEORGE P. SLOVER Senior Policy Counsel CONSUMERS UNION 1101 17th Street, N.W. Suite 500 Washington, D.C. 20036

TABLE OF CONTENTS Page TABLE OF AUTHORITIES... ii INTEREST OF AMICI CURIAE... 1 INTRODUCTION... 3 ARGUMENT... 6 I. THE DECISION BELOW MISAPPLIES THE LAW AND CONTRAVENES CONGRESSIONAL PURPOSE... 6 A. No Federal Safety Requirements Apply To Off-Label Uses Of Medical Devices... 6 B. Failure-To-Warn And Design-Defect Claims Arising From Injuries Attributable To Manufacturers Off-Label Marketing Parallel Any Applicable Federal Requirements... 12 II. THE DECISION BELOW EXEMPLI- FIES AND ADDS TO WIDESPREAD CONFUSION AND DISCORD AMONG LOWER COURTS REQUIRING THIS COURT S REVIEW... 14 III. THE RESULT BELOW MAKES PREEMPTION A SHIELD AGAINST LIABILITY FOR UNLAWFUL CON- DUCT AND WILL EXACERBATE THE GROWING HARMS ATTRIBUTABLE TO OFF-LABEL PROMOTION... 18 CONCLUSION... 20

ii TABLE OF AUTHORITIES Page CASES Alton v. Medtronic, Inc., 970 F. Supp. 2d 1069 (D. Or. 2013)... 16 Anderson v. Medtronic, Inc., No. 14-cv-00615- BAS(RBB), 2015 U.S. Dist. LEXIS 61750 (S.D. Cal. May 6, 2015)... 17 Angeles v. Medtronic, Inc., 863 N.W.2d 404 (Minn. Ct. App. 2015)... 17 Arthur v. Medtronic, Inc., No. 4:14-CV-52 (CEJ), 2014 U.S. Dist. LEXIS 110229 (E.D. Mo. Aug. 11, 2014)... 17 Arvizu v. Medtronic, Inc., 41 F. Supp. 3d 783 (D. Ariz. 2014)...15, 17 Bates v. Dow AgroSciences LLC, 544 U.S. 431 (2005)... 12, 14, 15 Beavers-Gabriel v. Medtronic, Inc., 15 F. Supp. 3d 1021 (D. Haw. 2014)... 17 Buckman Co. v. Plaintiffs Legal Comm., 531 U.S. 341 (2001)...14, 15 Chisom v. Roemer, 501 U.S. 380 (1991)... 9 Dawson v. Medtronic, Inc., No. 3:13-cv-663- JFA, 2013 WL 4048850 (D.S.C. Aug. 9, 2013)... 16 Eidson v. Medtronic, Inc.: 981 F. Supp. 2d 868 (N.D. Cal. 2013)... 17 40 F. Supp. 3d 1202 (N.D. Cal. 2014)...16, 17 Garross v. Medtronic, Inc., 77 F. Supp. 3d 809 (E.D. Wis. 2015)... 17

iii Harrison v. PPG Indus., Inc., 446 U.S. 578 (1980)... 9 Hawkins v. Medtronic, Inc., 62 F. Supp. 3d 1144 (E.D. Cal. 2014)... 17 Hornbeck v. Medtronic, Inc., No. 13 C 7816, 2014 WL 2510817 (N.D. Ill. June 2, 2014)... 15 Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166 (C.D. Cal. 2013)... 17 Ledet v. Medtronic, Inc., No. 1:13CV200-LG- JMR, 2013 U.S. Dist. LEXIS 182448 (S.D. Miss. Dec. 30, 2013)... 17 Martin v. Medtronic, Inc., 32 F. Supp. 3d 1026 (D. Ariz. 2014)... 17 Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)...6, 10, 11, 12, 15 Ramirez v. Medtronic Inc., 961 F. Supp. 2d 977 (D. Ariz. 2013)... 14, 15, 16 Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)... 10, 11, 12, 15 Schouest v. Medtronic, Inc., 13 F. Supp. 3d 692 (S.D. Tex. 2014)...15, 17 Schuler v. Medtronic, Inc., No. CV 14-00241-R, 2014 WL 988516 (C.D. Cal. Mar. 12, 2014), appeal pending, No. 14-55565 (9th Cir.)... 16 Wright v. Medtronic, Inc., 81 F. Supp. 3d 600 (W.D. Mich. 2015)... 17

iv STATUTES, REGULATIONS, AND RULES Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et seq....3, 7, 9 21 U.S.C. 321(h)... 7 21 U.S.C. 331... 4 21 U.S.C. 331(a)... 13 21 U.S.C. 333... 4 21 U.S.C. 352...12, 17 21 U.S.C. 352(f)... 3, 4, 13 21 U.S.C. 360(k) ( 510(k))...10, 12 21 U.S.C. 360c(a)... 7 21 U.S.C. 360c(a)(2)(B)... 8 21 U.S.C. 360c(a)(2)(C)... 9 21 U.S.C. 360e... 3 21 U.S.C. 360e(d)... 6, 10-11 21 U.S.C. 360e(d)(1)(A)... 8 21 U.S.C. 360e(d)(6)... 8 21 U.S.C. 360k...10, 15 21 U.S.C. 360k(a)... 3, 9, 10, 12 21 U.S.C. 396... 4, 9 Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539... 3, 6, 8, 10, 12 21 C.F.R.: 801.4... 3, 4, 7, 12, 13 801.5... 3, 4, 12, 17 801.5(a)... 13 814.39... 8

v 814.80... 3 888.3070... 7 890.3150... 7 890.5380(a)... 7 Sup. Ct. R.: Rule 37.2(a)... 1 Rule 37.6... 1 LEGISLATIVE MATERIALS 121 Cong. Rec. 10,688 (1975)... 10 H.R. Rep. No. 94-853 (1976)...10, 11 OTHER MATERIALS Am. Acad. of Orthopaedic Surgeons, Position Statement 1177, Off-Label Use of Medical Products (June 2009), available at http:// www6.aaos.org/news/pdfopen/pdfopen. cfm?page_url=http://www.aaos.org/about/ papers/position/1177.asp... 4 Am. Med. Ass n: Opinion 2.072, Ethically Sound Innovation in Medical Practice (issued 2014), available at http://www.ama-assn.org/ama/pub/ physician-resources/medical-ethics/codemedical-ethics/opinion2072.page... 5

vi Policy Statement H-120.988, Patient Access to Treatments Prescribed by Their Physicians (issued 1988), available at https://www. ama-assn.org/ssl3/ecomm/policyfinderform. pl?site=www.ama-assn.org&uri=/resources/ html/policyfinder/policyfiles/hne/h- 120.988.HTM... 4, 19 Ctrs. for Medicare & Medicaid Servs., NHE Fact Sheet, https://www.cms.gov/researchstatistics-data-and-systems/statistics-trendsand-reports/nationalhealthexpenddata/nhefact-sheet.html (last modified July 28, 2015)... 2 David Chang, Internalizing the External Costs of Medical Device Preemption, 65 Hastings L.J. 283 (2013)... 19 Thomas S. Crane, The Next Enforcement Wave Off-Label Marketing of Medical Devices, 21 Health Law. 22 (2009)... 19 Rebecca Dresser & Joel Frader, Off-Label Prescribing: A Call for Heightened Professional and Government Oversight, 37 J.L. Med. & Ethics 476 (2009)... 5 Stephanie M. Greene & Lars Noah, Off-Label Drug Promotion and the First Amendment, 162 U. Pa. L. Rev. Online 239 (2014)... 18 Aaron S. Kesselheim & Michelle M. Mello, Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection, 92 N.C. L. Rev. 1539 (2014)... 18

INTEREST OF AMICI CURIAE 1 Amici curiae are non-partisan, non-profit organizations that seek to protect the safety of consumers, including consumers of medical devices, through education and advocacy. Amici have an interest in ensuring that patients harmed by an unsafe off-label use of a medical device marketed by a manufacturer for that use have the right to seek legal recourse for their injuries. AARP is a non-partisan, non-profit organization, with a membership that helps people turn their goals and dreams into real possibilities, strengthens communities, and fights for the issues that matter most to families, such as healthcare, employment, and income security. Through education, advocacy, and service, AARP seeks to enhance the quality of life for all by promoting independence, dignity, and purpose. As the country s largest membership organization, AARP has long supported laws and public policies designed to protect the rights of older people and to preserve their access to legal relief when they are harmed by unlawful acts. Among other activities, AARP advocates for improved access to the civil justice system and supports the availability of the full range of enforcement tools, including state-law tort remedies. 1 Pursuant to this Court s Rule 37.2(a), counsel for amici provided notice to all parties of amici s intention to file this brief at least 10 days before its due date. The parties have consented to the filing of this brief, and letters expressing their consent have been filed with the Clerk. Pursuant to this Court s Rule 37.6, amici affirm that no counsel for a party authored this brief in whole or in part and that no person other than amici, their members, and their counsel made a monetary contribution intended to fund the preparation or submission of this brief.

2 AARP has a particular interest in this case because older people use health care services at a much higher rate than the rest of the population, 2 and therefore are disproportionately affected by unsafe medical treatments, including unsafe medical devices. Consumers, including older people, must be able to seek judicial recourse when they are harmed by unsafe medical devices, especially when those harms are caused by manufacturers that break the law and urge health care providers to use their devices in an unsafe manner. Consumers Union of United States, Inc. d/b/a Consumer Reports ( CR ) is an expert, independent, non-profit organization whose mission is to work for a fair, just, and safe marketplace for all consumers and to empower consumers to protect themselves. CR is the world s largest independent product-testing organization. It has more than 8 million subscribers to its magazine, website, and other publications. Since its founding in 1936, it has advocated for consumers on a variety of issues, including effective consumer protection laws to hold corporations accountable both for the quality of their goods and services and for the way in which they are marketed. Like AARP, CR seeks to empower consumers by protecting their right to seek legal redress when they are harmed by misbranded medical devices. CR strongly supports the availability and use of state-law tort remedies as appropriate to check the dangers of off-label promotion. 2 See Ctrs. for Medicare & Medicaid Servs., NHE Fact Sheet, https://www.cms.gov/research-statistics-data-and-systems/ statistics-trends-and-reports/nationalhealthexpenddata/nhefact-sheet.html (last modified July 28, 2015).

3 INTRODUCTION Manufacturers marketing of medical devices for unapproved (or off-label ) uses presents a serious and growing threat to consumer health and safety. The decision below exacerbates that threat by inoculating device manufacturers from state-law liability when they unlawfully promote uses of their devices in ways that have not been approved by the Food and Drug Administration ( FDA ). That sweeping preemption of state-law protections should be rejected by this Court. The Medical Device Amendments ( MDA ) to the Food, Drug, and Cosmetic Act ( FDCA ) preempt any state requirement with respect to a medical device that is different from, or in addition to, any federal requirement applicable to that same device which relates to the safety or effectiveness of the device or to any other matter included in a [federal] requirement applicable to the device. 21 U.S.C. 360k(a). The FDA, in a process called premarket approval, imposes federal requirements on the uses of a Class III device indicated on the device s labeling when it concludes that the device is safe and effective for those uses. 3 See id. 360e. A medical device s label may indicate only FDA-approved uses. See, e.g., id. 352(f), 360e; 21 C.F.R. 801.4-801.5, 814.80. 3 A device is regulated as Class III if (1) less stringent controls have not been shown to assure its safety and effectiveness, (2) it is purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or (3) it presents a potential unreasonable risk of illness or injury. 21 U.S.C. 360c(a)(1)(C). The Infuse device at issue in this case is a Class III device.

4 Off-label uses of medical devices present special considerations. Although off-label uses of Class III devices are not inherently unsafe, they have not passed the FDA s premarket approval process and therefore lack the assurance of safety and effectiveness that attaches to such approval. Physicians are permitted to prescribe off-label uses because, under a physician s care and supervision, off-label uses can benefit patients. See 21 U.S.C. 396. Ethical considerations, however, generally limit health care professionals to prescribing off-label only when such use is based upon sound scientific evidence or sound medical opinion. Am. Med. Ass n, Policy Statement H-120.988, Patient Access to Treatments Prescribed by Their Physicians (issued 1988) ( AMA Policy Statement H-120.988 ), available at https://www.amaassn.org/ssl3/ecomm/policyfinderform.pl?site=www. ama-assn.org&uri=/resources/html/policyfinder/ policyfiles/hne/h-120.988.htm. By contrast, the FDA prohibits manufacturers from marketing their products for off-label uses. A manufacturer that advertises a device for an off-label use renders that device misbranded, see 21 U.S.C. 352(f); 21 C.F.R. 801.4-801.5, which in turn subjects the manufacturer to civil and criminal penalties, see 21 U.S.C. 331, 333. The reason for treating off-label promotion differently from off-label prescription is that the former poses inherent conflicts of interest, with economic incentives potentially tainting medical judgment. 4 Prohibiting off-label promotion also 4 See, e.g., Am. Acad. of Orthopaedic Surgeons, Position Statement 1177, Off-Label Use of Medical Products 3-4 (June 2009) (advising to be aware of company sales and marketing tactics that may undermine the free and credible exchange of scientific information regarding off-label uses and to avoid compromising situations that may call independent medical

5 give[s] manufacturers an incentive to sponsor the research needed to determine whether off-label uses are safe and effective. Rebecca Dresser & Joel Frader, Off-Label Prescribing: A Call for Heightened Professional and Government Oversight, 37 J.L. Med. & Ethics 476, 483 (2009). The crux of both rationales is ensuring patient safety. In the decision below, the Tenth Circuit held that premarket approval shields a device s manufacturer from state-law liability for injuries resulting from any use of the device, even when the manufacturer violated federal law by promoting the very off-label use of the device that caused the patient harm. Pet. App. 20a-21a. That result gives safe haven to bad actors at the expense of innocent patients, abandons the teaching of this Court s precedents, and paradoxically uses preemption to subvert the federal policy of patient safety. Review of the decision below is urgently needed to restore the balance Congress intended between the primacy of federal safety regulation and the availability of state-law remedies. judgment into question ), available at http://www6.aaos.org/ news/pdfopen/pdfopen.cfm?page_url=http://www.aaos.org/ about/papers/position/1177.asp; Am. Med. Ass n, Opinion 2.072, Ethically Sound Innovation in Medical Practice (issued 2014) (advising doctors to [b]e aware of influences that may drive the creation and adoption of innovative practices for reasons other than patient or public benefit ), available at http://www.amaassn.org/ama/pub/physician-resources/medical-ethics/codemedical-ethics/opinion2072.page.

6 ARGUMENT I. THE DECISION BELOW MISAPPLIES THE LAW AND CONTRAVENES CONGRES- SIONAL PURPOSE The court below made two fundamental errors. First, it did not consider the way in which Congress intended the statute and its surrounding regulatory scheme to affect business, consumers, and the law. Medtronic, Inc. v. Lohr, 518 U.S. 470, 486 (1996). Congress s purpose should have been the ultimate touchstone of the lower court s analysis, id. at 485 (internal quotation marks omitted), but instead it played no discernible role. Second, the lower court misconstrued the FDA s regulatory scheme, in particular the vital importance of a device s intended use, as reflected in its approved labeling, in regulating its safety and effectiveness. A. No Federal Safety Requirements Apply To Off-Label Uses Of Medical Devices The requirements that the FDA imposes on a Class III medical device through premarket approval are not just device-specific. They are also use-specific. See, e.g., 21 U.S.C. 360e(d). Accordingly, when a manufacturer relies on premarket approval as the preemptive federal requirement under the MDA, the underlying regulatory scheme demands that a court, in deciding preemption, consider whether that requirement is specific to a particular device and the particular use of that device. That rule is the necessary extension of this Court s holding in Lohr that the overarching concern of the statutory and regulatory language was that pre-emption occur only where a particular state requirement threatens to interfere with a specific federal interest. 518 U.S. at 500.

7 Intended use is fundamental in determining whether and to what extent a device is subject to federal regulation. The FDA defines intended use of a device as the objective intent of its manufacturer as determined by such person[ s] expressions or the circumstances surrounding the distribution of the [device]. 21 C.F.R. 801.4. As a threshold matter, intended use can determine whether a thing is regulated as a device at all under the FDCA. See 21 U.S.C. 321(h). For example, if the manufacturer of a treadmill claims that the equipment redevelops muscle, restores motion, or acts as an adjunct treatment for obesity, then the treadmill is intended for medical purposes and is subject to FDA regulation, see 21 C.F.R. 890.5380(a), but a treadmill intended only to help consumers trim their waistlines escapes FDA requirements altogether. Once a device s intended use subjects it to FDA regulation, intended use also limits the extent of that regulation. See 21 U.S.C. 360c(a). For example, a screw intended for use in constructing a car is not a medical device at all. See id. 321(h). But, if that same screw were intended for use in constructing crutches, it would be a Class I medical device subject to minimal regulation. See 21 C.F.R. 890.3150. And, if that screw were intended for use in the human spine, it would be a Class II or Class III medical device subject to stricter requirements. See, e.g., id. 888.3070. Similarly, when a device s intended use requires it to endure the rigorous premarket approval process, the statute makes clear that the FDA is to evaluate the device s safety and effectiveness only with respect to its intended use; off-label uses are not evaluated. In making the determination whether to approve or deny [an] application for premarket approval, the

8 Secretary of Health and Human Services, acting through the FDA, shall rely on the conditions of use included in the proposed labeling as the basis for determining whether or not there is a reasonable assurance of safety and effectiveness. 21 U.S.C. 360e(d)(1)(A) (emphasis added); see also id. 360c(a)(2)(B) (for purposes of premarket approval, the safety and effectiveness of a device are to be determined... with respect to the conditions of use... in the labeling of the device ). Once the FDA approves a Class III device for a particular use, any additional intended uses of the device that affect its safety or effectiveness must secure FDA approval through a supplemental application. See id. 360e(d)(6); 21 C.F.R. 814.39. In the decision below, the Tenth Circuit misunderstood the FDA s use-specific regulatory scheme when it construed the MDA s preemption provision. It proceeded as if premarket approval imposes requirements on all uses of a Class III device, such that even state-law duties to refrain from misbranding the device and to make the device safe for intended uses would impose requirements different from, or in addition to, those imposed by premarket approval. See Pet. App. 17a-18a ( [T]he statute preempts any effort to use state law to impose a new requirement on a federally approved medical device. ); id. at 21a ( once a device survives premarket approval, it s immune from state tort suits that seek to impose different or additional safety-related duties ). That premise is false. Premarket approval imposes requirements on some uses of a device, but not others, and for good reason: It would be enormously inefficient and virtually impossible for the FDA to try to weigh[] any probable benefit to health... against

9 any probable risk of injury or illness, 21 U.S.C. 360c(a)(2)(C), for every potential use of a device, even uses for which the manufacturer has not sought approval and perhaps has not even studied. Attempting to square this circle, the court below observed that Congress spoke directly to off-label uses in 21 U.S.C. 396, which says the FDCA shall not be read to limit physicians authority to prescribe a legally marketed device, and concluded that therefore the absence of any mention of on- and off-label uses in 360k(a) becomes all the harder to ignore, a sort of dog that didn t bark. Pet. App. 18a. Section 396 does not address requirements, however, and this Court has forcefully and explicitly rejected the Conan Doyle approach to statutory construction in the past. Chisom v. Roemer, 501 U.S. 380, 406 (1991) (Scalia, J., dissenting) (citing Harrison v. PPG Indus., Inc., 446 U.S. 578, 592 (1980)). Section 396 supports, rather than forecloses, petitioner s position that Congress did not intend to preempt claims arising from injuries attributable to a manufacturer s marketing of a device for an unsafe, off-label use. Although 396 preserves the authority of a health care practitioner to prescribe devices for off-label uses, it just as clearly tells manufacturers that the FDA still has authority to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device, specifically including any existing prohibition on the promotion of unapproved uses of legally marketed devices. 21 U.S.C. 396 (emphasis added). The decision below failed to appreciate the distinction between prescription and promotion of off-label uses, which can be the difference between innovation that benefits patients and potentially criminal behavior that places patients at

10 undue risk. Protecting physicians prerogative to prescribe off-label cannot support giving manufacturers carte blanche to promote off-label, and the dog that didn t bark canon is an untenable basis for a statutory construction that divorces the text from its regulatory scheme. The Tenth Circuit s approach also abandons the core congressional purpose that has guided this Court s common-sense construction of requirement in 360k(a). The MDA was focused primarily upon the need for protection of patients and consumers. H.R. Rep. No. 94-853, at 16 (1976). When Senator Kennedy introduced the MDA on the Senate floor, he said, The legislation is written so that the benefit of the doubt is always given to the consumer. 121 Cong. Rec. 10,688 (1975) (statement of Sen. Ted Kennedy). Congress s stated purpose to protect patients and consumers has been this Court s ultimate touchstone in construing the MDA, as it is in every pre-emption case. Lohr, 518 U.S. at 485 (internal quotation marks omitted). Informed by that touchstone, this Court held that substantial equivalence determinations under 510(k), 21 U.S.C. 360(k), are not requirements under 360k because they focus[] on equivalence, not safety, and therefore provide little protection to the public. 518 U.S. at 493 (internal quotation marks omitted). By contrast, this Court held that premarket approval is a requirement because, unlike substantial equivalents that have never been formally reviewed under the MDA for safety or efficacy, premarket approval requires the FDA to determine[] that a device offers a reasonable assurance of safety and effectiveness. Riegel v. Medtronic, Inc., 552 U.S. 312, 323 (2008) (citing 21

11 U.S.C. 360e(d) and quoting Lohr, 518 U.S. at 493). 5 The decision below abandoned this safety-based distinction by holding that a manufacturer is immunized from liability for injuries caused by a device that was not safe for the off-label use for which the manufacturer marketed it a use that has never been formally reviewed under the MDA for safety and efficacy. Id. (internal quotation marks omitted). Permitting state tort law to remedy harms caused by off-label uses promoted by manufacturers cannot possibly require[] a manufacturer s [device] to be safer... than the model the FDA has approved, id. at 325, because the FDA, by definition, never approved the device for such uses in the first place. Furthermore, off-label uses are subject only to the FDA s limited authority to regulate misbranded or adulterated devices already on the market. But Congress created the premarket approval process precisely because the FDA s post-hoc authority regarding misbranding had not effectively protected consumers from harm. See, e.g., H.R. Rep. No. 94-853, at 11 ( An even more serious drawback of the existing authority is that FDA cannot act against a hazardous medical device until after it is on the market and then must prove misbranding or adulteration. ). Federal regulations regarding misbranding and adulteration reflect important but entirely generic concerns about device regulation generally, and do not reflect the sort of specific federal interest that has preemptive force. Lohr, 518 U.S. at 5 Although this Court was not called upon in Riegel to reach a holding regarding whether requirements need to be usespecific in the context of premarket approval, the Court s discussion of the regulatory scheme underlying premarket approval recognized its use-specific character. See, e.g., Riegel, 552 U.S. at 318.

12 500, 501. This Court acknowledged as much when it held that the 510(k) process does not preempt state-law claims because it only require[s] [manufacturers] to comply with general standards the lowest level of protection applicable to all medical devices, and including... the misbranding and adulteration provisions of the [FDCA]. Id. at 493. The decision below erred in concluding that premarket approval imposes preemptive requirements on off-label uses of a medical device. B. Failure-To-Warn And Design-Defect Claims Arising From Injuries Attributable To Manufacturers Off-Label Marketing Parallel Any Applicable Federal Requirements Even assuming that federal regulations applicable to misbranding and adulteration fall within the scope of requirements that can preempt state law under 360k(a), the decision below erred in concluding that petitioner s claims were not parallel to those requirements. The MDA does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case parallel, rather than add to, federal requirements. Riegel, 552 U.S. at 330. Petitioner s state-law claims, which apply tort principles to impose liability on conduct that violates federal law, clearly qualify as parallel. See Bates v. Dow AgroSciences LLC, 544 U.S. 431, 447 (2005). As discussed above, a device becomes misbranded when its intended use diverges from the use indicated on the device s FDA-approved label, see 21 U.S.C. 352; 21 C.F.R. 801.4-801.5, and a device s intended use is the objective intent of its manufacturer, as determined by such person[ s]

13 expressions, 21 C.F.R. 801.4. Thus, when a manufacturer in its oral, written, printed, or graphic advertising, id. 801.5(a), promotes the use of a device that is not on the device s label, the manufacturer violates federal law by introduc[ing]... into interstate commerce a misbranded device. 21 U.S.C. 331(a), 352(f). A manufacturer s representations about a device s use can thus be the trigger for misbranding. 6 The decision below, however, focused only on the labeling aspect of misbranding, without acknowledging the essential role played by a manufacturer s conduct. It concluded that misbranding regulations do not provide parallels to petitioner s failure-towarn and misrepresentation claims because misbranding regulations govern only a device s labeling, whereas petitioner s claims attack[] not just Infuse s label but also Medtronic s advertising and oral and written representations to her, her doctor, and others. Pet. App. 11a-12a. This conclusion exposes a fundamental misunderstanding of the law. As Judge Lucero correctly explained in dissent, Medtronic s allegedly illegal promotion of Infuse, including Medtronic s advertising and oral and written statements made by its representatives, is properly viewed as evidence that Infuse was misbranded and/or adulterated in violation of the law. Id. at 36a (Lucero, J., concurring in part and dissenting in part). Medtronic s conduct in misbranding 6 Once a manufacturer introduces a device into interstate commerce, that manufacturer s off-label promotion of the device renders its directions for use inadequate, see 21 C.F.R. 801.5(a), which in turn renders it misbranded, see 21 U.S.C. 352(f ), which in turn places the manufacturer the one introduc[ing] or deliver[ing] the device into interstate commerce in violation of federal law.

14 Infuse independently breaches state-law duties of care, see id. at 40a-42a (discussing applicable Oklahoma law), and therefore petitioner s failure-towarn and design-defect claims premised on such duties do not exist solely by virtue of the FDCA, Buckman Co. v. Plaintiffs Legal Comm., 531 U.S. 341, 352-53 (2001). Importantly, petitioner s state-law claims would not impose[] a broader obligation on Medtronic than federal regulations, Bates, 544 U.S. at 453, because both state-law duties and federal law prohibit marketing a device for unreasonably dangerous uses and uses for which adequate warnings have not been provided. See, e.g., Ramirez v. Medtronic Inc., 961 F. Supp. 2d 977, 992 (D. Ariz. 2013) (no express preemption because [plaintiff] has premised her claims here not just on the fact that her surgeon used Infuse off-label... but that he did so as a result of Medtronic s active promotion of Infuse s off-label merits ). Therefore, Medtronic need only refrain from off-label promotion an obligation it already has under parallel federal-law requirements to avoid liability on petitioner s state-law claims. To comply with state tort law, Medtronic would not need to change its label, redesign its device, or otherwise exceed federal requirements, as the decision below incorrectly assumed. See Pet. App. 22a-23a. II. THE DECISION BELOW EXEMPLIFIES AND ADDS TO WIDESPREAD CONFUSION AND DISCORD AMONG LOWER COURTS REQUIRING THIS COURT S REVIEW This Court should also grant the petition because it presents an important opportunity to clarify widespread confusion and disagreement in lower courts about how to apply this Court s precedents. The

15 decision below explicitly asks for this Court s help. See Pet. App. 9a-10a ( How are we supposed to apply all these competing instructions [from the Supreme Court]?... One can t help but wonder if perhaps some of those rules warrant revisiting and reconciliation. ). It is only the most recent example of lower courts struggl[ing] to apply Lohr, Riegel, Bates, and Buckman to state-law claims involving off-label promotion. See Schouest v. Medtronic, Inc., 13 F. Supp. 3d 692, 700-01 (S.D. Tex. 2014). That struggle extends to both questions presented in this appeal: (1) whether premarket approval imposes federal requirements on off-label uses of a medical device; and (2) whether state-law claims for design defect, misrepresentation, and failure-to-warn parallel federal requirements, where the claims arise from a manufacturer s marketing of the device for an offlabel use. Therefore, the decision below presents an ideal vehicle for this Court to resolve two important and recurring questions of federal preemption law that continue to divide lower courts. On the first question, some courts, including the decision below, hold that premarket approval imposes potentially preemptive federal requirements on all uses of a device, including off-label uses, see, e.g., Arvizu v. Medtronic, Inc., 41 F. Supp. 3d 783, 790 (D. Ariz. 2014) (holding that 360k applies when the FDA imposes requirements on a device, not specific uses of a device ), whereas other courts hold that the requirements imposed by premarket approval are use-specific, see, e.g., Ramirez, 961 F. Supp. 2d at 991; Hornbeck v. Medtronic, Inc., No. 13 C 7816, 2014 WL 2510817, at *3 (N.D. Ill. June 2, 2014) (in premarket approval, the FDA consider[s] a specific use, and [i]t does not follow

16 that the FDA s oversight with respect to that specific use protects all other uses ). Lower courts also vary wildly on the second question. See Alton v. Medtronic, Inc., 970 F. Supp. 2d 1069, 1088-96 (D. Or. 2013) (summarizing broad[], narrow[], and still more narrow[] approaches). That discord has been especially pronounced among the district courts in the Ninth Circuit, which have taken at least three distinct approaches: Some have held that federal law does not prohibit off-label promotion at all, and therefore claims based on injuries arising from off-label promotion are non-parallel and expressly preempted. See, e.g., Schuler v. Medtronic, Inc., No. CV 14-00241-R, 2014 WL 988516, at *1 (C.D. Cal. Mar. 12, 2014), appeal pending, No. 14-55565 (9th Cir.); accord Dawson v. Medtronic, Inc., No. 3:13-cv-663-JFA, 2013 WL 4048850, at *6 (D.S.C. Aug. 9, 2013). Others have held that federal law does not prohibit off-label promotion, but that statelaw claims arising from injuries attributable to offlabel promotion nevertheless escape express preemption because they are premised on conduct that contravenes state-law duties of such generality as not to present any risk of interference with the federal medical-device regulatory scheme. E.g., Alton, 970 F. Supp. 2d at 1098. Still others hold that such state-law claims are permitted because they parallel federal law. See, e.g., Eidson v. Medtronic, Inc., 40 F. Supp. 3d 1202, 1225-26 (N.D. Cal. 2014); Ramirez, 961 F. Supp. 2d at 990. The decision below only adds to the confusion. Despite variations in lower courts rulings, there has been a growing consensus that certain state-law theories of liability tied to off-label promotion, such

17 as negligent misrepresentation, 7 breach of warranty, 8 and negligence, 9 survive preemption. In particular, other courts addressing claims nearly identical to petitioner s have held that 21 U.S.C. 352 and 21 C.F.R. 801.5 are sufficiently parallel to survive preemption, in direct disagreement with the decision below. See, e.g., Eidson v. Medtronic, Inc., 981 F. Supp. 2d 868, 884 n.4 (N.D. Cal. 2013). The decision below perpetuates the confusion in this area of law and warrants this Court s review. 7 See, e.g., Garross v. Medtronic, Inc., 77 F. Supp. 3d 809, 815-16 (E.D. Wis. 2015); Hawkins v. Medtronic, Inc., 62 F. Supp. 3d 1144, 1162 (E.D. Cal. 2014); Eidson, 40 F. Supp. 3d at 1224-26; Arthur v. Medtronic, Inc., No. 4:14-CV-52 (CEJ), 2014 U.S. Dist. LEXIS 110229, at *19-20 (E.D. Mo. Aug. 11, 2014). But see Ledet v. Medtronic, Inc., No. 1:13CV200-LG-JMR, 2013 U.S. Dist. LEXIS 182448, at *14-15 (S.D. Miss. Dec. 30, 2013). 8 See, e.g., Anderson v. Medtronic, Inc., No. 14-cv-00615- BAS(RBB), 2015 U.S. Dist. LEXIS 61750, at *15-17 (S.D. Cal. May 6, 2015); Wright v. Medtronic, Inc., 81 F. Supp. 3d 600, 617-18 (W.D. Mich. 2015); Arvizu, 41 F. Supp. 3d at 788; Martin v. Medtronic, Inc., 32 F. Supp. 3d 1026, 1045-46 (D. Ariz. 2014); Beavers-Gabriel v. Medtronic, Inc., 15 F. Supp. 3d 1021, 1042 (D. Haw. 2014); Schouest, 13 F. Supp. 3d at 707; Arthur, 2014 U.S. Dist. LEXIS 110229, at *21-25; Houston v. Medtronic, Inc., 957 F. Supp. 2d 1166, 1180-81 (C.D. Cal. 2013); Angeles v. Medtronic, Inc., 863 N.W.2d 404, 420-21 (Minn. Ct. App. 2015). 9 See, e.g., Garross, 77 F. Supp. 3d at 815-16; Martin, 32 F. Supp. 3d at 1044-45; Beavers-Gabriel, 15 F. Supp. 3d at 1040-42; Arvizu, 41 F. Supp. 3d at 788.

18 III. THE RESULT BELOW MAKES PREEMP- TION A SHIELD AGAINST LIABILITY FOR UNLAWFUL CONDUCT AND WILL EXACERBATE THE GROWING HARMS ATTRIBUTABLE TO OFF-LABEL PROMO- TION Whether the growing number of patients injured as a result of manufacturers promotion of off-label uses, never approved as safe and effective, have any remedy at all is a question of paramount patient safety. The Tenth Circuit s answer no will embolden unlawful conduct and make the prescription of off-label uses less safe. Despite federal prohibitions, the past decade has revealed that off-label promotion is quite common in the drug and medical device industries. Aaron S. Kesselheim & Michelle M. Mello, Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection, 92 N.C. L. Rev. 1539, 1542 (2014). Nearly every major manufacturer has now been investigated by government prosecutors for violating the FDCA and the FDA s enabling rules on off-label promotion. Id. The growing prevalence of off-label promotion is largely due to the significant additional revenues that such uses can bring medical device manufacturers. See, e.g., Stephanie M. Greene & Lars Noah, Off-Label Drug Promotion and the First Amendment, 162 U. Pa. L. Rev. Online 239, 258 (2014) ( Research indicates... that the goal of off-label marketing schemes is to generate more revenue than FDA-approved indications could. ). And, [w]hen projected sales are high enough, the risk of paying fines for off-label promotion is apparently worth taking. Id. This deleterious incentive is heightened in the medical device

19 field because [d]evice innovation is more physiciandriven than innovation in pharmaceuticals. Thomas S. Crane, The Next Enforcement Wave Off-Label Marketing of Medical Devices, 21 Health Law. 22, 25 (2009). Immunizing device manufacturers from liability for injuries caused by unsafe off-label uses that the manufacturers themselves promote, as the decision below has, creates a pernicious hazard that will exacerbate this skewed incentive. State tort law has an important role to play in deterring manufacturers from promoting uses of a device that have not been proven safe and effective, which in turn helps to keep patients safer by removing inappropriate outside influences from medical decisions regarding off-label uses. Cf. David Chang, Internalizing the External Costs of Medical Device Preemption, 65 Hastings L.J. 283, 300 (2013). Thus, state tort law is a necessary complement to federal regulation. Without a statelaw deterrent, the safety risks attached to off-label promotion will grow, and injuries caused by those growing risks will go unremedied. It is no answer to these risks to cite the potential innovative benefits of off-label uses, as the decision below did. See Pet. App. 18a, 22a-23a. Allowing claims like petitioner s to proceed would not inhibit the responsible prescription of off-label uses, based upon sound scientific evidence or sound medical opinion. AMA Policy Statement H-120.988. Rather, permitting state tort law to remedy injuries attributable to off-label promotion preserves physician freedom to innovate while removing outside influences that can compromise patient safety.

20 CONCLUSION The petition for a writ of certiorari should be granted. Respectfully submitted, KELLY BAGBY MAAME GYAMFI AARP FOUNDATION LITIGATION, INC. 601 E Street, N.W. Washington, D.C. 20049 (202) 434-2103 EILEEN B. HERSHENOV Vice President & General Counsel CONSUMER REPORTS 101 Truman Avenue Yonkers, NY 10703 October 15, 2015 DAVID C. FREDERICK Counsel of Record MATTHEW R. HUPPERT KELLOGG, HUBER, HANSEN, TODD, EVANS & FIGEL, P.L.L.C. 1615 M Street, N.W. Suite 400 Washington, D.C. 20036 (202) 326-7900 (dfrederick@khhte.com) GEORGE P. SLOVER Senior Policy Counsel CONSUMERS UNION 1101 17th Street, N.W. Suite 500 Washington, D.C. 20036