Document: 531 U.S. 341121 S.Ct. 1012148 L.Ed.2d 854 NOTICE: This opinion is subject to formal revision before publication in the preliminary print of United States Reports. Readers are requested notify Reporter Decisions, Supreme Court States, Washington, D. C. 20543, any typographical or other errors, order that corrections may be made goes press.BUCKMAN COMPANY, PETITIONERv.PLAINTIFFS' LEGAL COMMITTEE No. 98-1768. SUPREME COURT OF THE UNITED STATES Argued December 4, 2000 Decided February 21, 2001 Syllabus Respondent represents plaintiffs claiming injuries caused by use orthopedic bone screws pedicles their spines. Petitioner assisted screws' manufacturer securing approval for devices from Food and Drug Administration (FDA Agency), which has regulatory authority under Federal Food, Drug, Cosmetic Act (FDCA), as amended Medical Devices Amendments 1976 (MDA). While a class normally must go through time-consuming process receive premarket (PMA), they were approved an exception, known 510(k) process, predicate devices-devices already on market when MDA was enacted-and "substantially equivalent" devices. The application filed petitioner sought clearance arm leg bones, not spine. Claiming FDA would have had fraudulent representations regarding intended use, damages state tort law. District dismissed these fraud-on-the-FDA claims on, inter alia, ground pre-empted MDA. Third Circuit reversed. Held: plaintiffs' state-law conflict with, therefore impliedly by, FDCA, Pp. 5-11. (a) relationship between federal agency entity it regulates inherently because originates from, governed terminates according Because petitioner's dealings prompted very matter statements dictated statute-and contrast situations implicating "federalism concerns historic primacy regulation [health safety matters]," Medtronic, Inc. v. Lohr, 518 470, 485-no presumption against pre-emption obtains this case. here stems fact statutory scheme amply empowers punish deter fraud Agency, Agency uses achieve delicate balance objectives can skewed allowing claims. lacks PMA review's rigor, former does set forth comprehensive determining substantial equivalence with device. Other provisions give enforcement options allow make measured response suspected upon Agency. flexibility critical component framework pursues its difficult (and often competing) regulating medical device marketing distribution without intruding decisions committed FDCA health care professionals. 5-8. (b) State-law inevitably FDA's responsibility police consistently Agency's judgment objectives. Complying detailed regime shadow 50 States' regimes will dramatically increase burdens facing potential applicants, who might deterred seeking potentially beneficial off-label uses-an accepted practice used some purpose than it-for fear being exposed unpredictable civil liability. Conversely, applicants' disclosures later judged insufficient court lead them submit information neither needs nor wants, thus delaying comparatively speedy and, turn, impeding competition prescription appropriate uses. Respondent's reliance Silkwood Kerr&nbhyph;McGee Corp., 464 238, misplaced. based traditional law principles, fraud-on-the-agency theory, unlike Silkwood, there clear evidence Congress enforced exclusively Government. In addition, MDA's express provision bar ordinary working principles. Geier American Honda Motor Co., 529 861, 869. And although Medtronic read certain causes actions parallel requirements, stand proposition violation support claim. 8-11. 159 F.3d 817, CERTIORARI TO APPEALS FOR THIRD CIRCUIT Rehnquist, J., delivered Court, O'Connor, Scalia, Kennedy, Souter, Ginsburg, Breyer, JJ., joined. Stevens, concurring judgment, Thomas, Opinion Chief Justice Rehnquist Court. 1 claim resulting consulting company manufacturer, AcroMed Corporation, navigating Plaintiffs say Agency) course obtaining screws. further such at least "but for" cause sustained implantation devices: Had been made, devices, injured. We hold 52 Stat. 1040, Device (MDA), 90 539, 21 U.S.C. 301 (1994 ed. Supp. IV). 2 * Regulation two Acts just named. separates into three categories: Class I those present no unreasonable risk illness injury require only general manufacturing controls; II possessing greater dangerousness warranting more stringent III "presen[t] injury" incur strictest regulation. 360c(a)(1)(c)(ii)(II). It disputed manufactured 3 complete thorough review marketed. (PMA) requires applicant demonstrate "reasonable assurance" both "safe ... [and] effective conditions prescribed, recommended, suggested proposed labeling thereof." 360e(d)(2)(A), (B). Among information, include all reports pertaining device's efficacy, see 360e(c)(1)(A); "a full statement components, ingredients, properties principle principles operation device," 360e(c)(1)(B); description methods in, facilities controls for, manufacture, processing, relevant, packing installation of, 360e(c)(1)(C); samples (when practicable), 360e(c)(1)(E); "specimens 360e(c)(1)(F). ordinarily quite time consuming "average 1,200 hours [for] each submission." 477 (1996) (citing Hearings Subcommittee Health Environment House Committee Energy & Commerce, 100th Cong., 1st Sess. (Ser. 100-34), p. 384 (1987); Kahan, Premarket Approval Versus Notification: Different Routes Same Market, 39 Cosm. L. J. 510, 512-514 (1984)). 4 An exception requirement exists prior enactment 1976. See 360e(b)(1)(A). allows "predicate" remain available until initiates completes process. avoid monopolistic consequences predicate-device manufacturers distribute (also pending completion review) shown 360e(b)(1)(B). 5 Demonstrating qualifies "510(k) process," refers section original containing provision. Section submissions following: "Proposed labels, labeling, advertisements sufficient describe device, directions use," CFR 807.87(e) (2000); "[a] indicating similar and/or different products comparable type commercial distribution, accompanied data statement," 807.87(f); submitter believes, best his her knowledge, submitted notification truthful accurate material omitted," 807.87(k); "[a]ny additional [FDA] Commissioner necessary finding whether substantially equivalent distribution," 807.87(l). 6 1984, screw spinal surgery. re Orthopedic Bone Screw Products Liability Litigation, 820 (CA3 1998). denied grounds lacked ibid. September 1985, assistance petitioner, another application. "The provided about again indicated rejected application, posed risks exhibited spinal-fixation systems." Ibid. third "AcroMed [petitioner] split parts, renamed 'nested plates' '[cancellous] separate component. applications, new specified: rather plates long bones arms legs. Buckman claimed components 1986." 7 Pursuant designation Judicial Panel Multidistrict Litigation transferee re: MDL 1014, Eastern Pennsylvania recipient 2,300 related Many action that, result, improperly given subsequently detriment. "fraud-on-the-FDA" claims, first expressly MDA, then, after our decision amounted improper assertion private right MDA.1 F.3d, 821. 8 A divided panel Appeals reversed, concluding pre-empted. granted certiorari, 530 ___ (2000), resolve among Courts question, Kemp Inc., 231 216, 233-236 (CA6 2000) (identifying holding pre-empted), we now reverse. 9 Policing agencies hardly field traditionally occupied," Rice Santa Fe Elevator 331 218, 230 (1947), warrant action. To contrary, character Cf. Boyle Technologies 487 500, 504-505 (1988) (allowing common where interests stake "uniquely federal" nature). Here, statute's provisions. Accordingly-and matters safety," U.S., 10 Given analytical framework, law.2 somewhat 11 As described detail above, sets demonstrated product "[p]roposed attesting explaining similarities differences (along supporting data), 807.87(f ). also empowered information. Admittedly, rigor: showing while latter involves inquiry efficacy Nevertheless, limited purpose, imposes applicants variety requirements designed enable statutorily required exception. 12 Accompanying disclosure various aimed detecting, deterring, punishing false during processes. investigate fraud, 372; 5.35 citizens report wrongdoing petition take action, 10.30. addition criminal proscription making Government, 18 1001 ed., IV),3 respond injunctive relief, 332 penalties, 333(f )(1)(A); seizing 334(a)(2)(D); pursuing prosecutions, 333(a). FDA4 disposal 13 For example, respect simultaneously maintains exhaustive processes ensure reasonably safe if within relatively short period time. Similarly, "off-label" usage (use FDA) corollary mission regulate area directly interfering medicine. See, e.g., Beck Azari, FDA, Off-Label Use, Informed Consent: Debunking Myths Misconceptions, 53 71, 76-77 (1998) (noting courts, several "FDA itself recogniz[e] value propriety use"). Indeed, recent amendment states part "[n]othing chapter shall construed limit interfere practitioner prescribe administer legally marketed patient condition disease legitimate practitioner-patient relationship." 396 Thus, charged task discretion 14 practical matter, complying applicants-burdens contemplated enacting Would-be discouraged expose associates (such petitioner) effect, could reporting despite disclaims intent medicine, IV), even though generally accepted.5 15 deemed court. Applicants then incentive deluge wants needs, evaluation encounter delays, would, impede delay professionals' ability uses.6 16 relies heavily 238 (1984), reads "creat[e] virtually irrefutable implied preemption damage remedies predicated alleged remedial scheme." Brief 34. case, however, respects. Silkwood's sort but duty owed producer plutonium fuel pins employee plant. 241. Moreover, turned specific "disclaimed interest promoting development utilization atomic energy means fail provide adequate injured exposure hazardous nuclear materials." Id., 257. contrast, 337(a). 17 suggests should reluctant find pre-emptive included 37. extent respondent posits anything apply circumstances, contention light conclusion last Term 861 saving clause "bar[s] principles." reject respondent's attempt characterize issue (common-law negligence allegedly defective pacemaker lead) "claims arising violations requirements." 38. Notwithstanding did squarely address question pre-emption, arose manufacturer's failure reasonable production product, solely requirements. 481. exist virtue cannot 19 sum, maintain here, relying predated enactments questions. On existence element reasons stated think litigation exert extraneous pull established Congress, scheme. 20 so ordered. NOTES: determined failed lack proximate cause, 821 1998), presently us. conclusion, view 360k. 1001(a) IV) provides: "[W]hoever, jurisdiction executive, legislative, judicial branch Government knowingly willfully falsifies, conceals covers up trick, scheme, fact; [or] makes materially false, fictitious representation; writing document knowing same contain entry; fined title imprisoned years, both." leaves doubt litigants authorized file suit noncompliance provisions: "[A]ll proceedings enforcement, restrain violations, name States." Green Schultz, Tort Law Deference Devices, 88 Geo. 2119, 2133 (2000) ("Physicians drugs uses"); Smith, Physician Modification Legally Marketed Devices: Regulatory Implications Under Act, 55 245, 251-252 (discussing terms "practice medicine doctrine[, which] stands firmly efforts directed primarily manufacturers, physicians"); 72 ("Off-label widespread community essential giving patients optimal care, ethics, most courts recognize"). likely impact administration duties, "will affect kind direct protect undue incursion." 30 Miree DeKalb County, 433 25 (1977)). 22 whom Thomas joins, judgment. 23 points out, link chain causation prove prevail reached market. (FDA) done nothing remove market, aware basis allegations, convinces me proved. agree case proceed.1 24 if, instant litigation, taken steps harm-causing depend speculation behavior counterfactual situation grounded agency's explicit actions. plaintiff able establish second-guessing decisionmaking overburdening personnel, thereby alleviating Government's central If determines occurred removal encroach upon, supplement facilitate, 495 (holding presence remedy impose "merely provides reason comply . law"); id., 513 (O'Connor, dissenting part) (same).2 26 analysis offers today, parties recognizing adverse integrity do believe advanced Court's harsh result. Kerr-McGee 251 (1984) (declining infer affords alternative redress preempted remedies). reason, concur disposition join opinion. Though my focuses claim, minutiae details system Therefore, fit neatly pre-existing jurisprudence, accurate, sense, "preempts" acknowledged appears position publicly concluded defrauded Amicus Curiae 24, 30, always position. recently 1994, took suits alleging applications "subsequently concluded" never met "initiated actions" responsible fraudulently approval. Talbott R. Bard, 94-1951 (CA1), reprinted App. Pet. Cert. Bard., O. T. 1995, 95-1321, 84a.

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