\\server05\productn\N\NYS\65-3\NYS307.txt unknown Seq: 1 18-MAR-10 13:28 THE MEANING OF THE PARALLEL REQUIREMENTS EXCEPTION UNDER LOHR AND RIEGEL MARK HERRMANN, DAVID BOOTH ALDEN, AND BRADLEY W. HARRISON * INTRODUCTION In Riegel v. Medtronic, Inc. , 1 the Supreme Court held that fed- eral law preempts most product liability claims against manufactur- ers for medical devices approved through the premarket approval (PMA) process. 2 The Court declared that 21 U.S.C. § 360k(a)—the express preemption provision added to the Federal Food, Drug, and Cosmetic Act (FDCA) 3 by the Medical Device Amendments of 1976 (MDA) 4 —bars state law claims that impose requirements “‘different from, or in addition to, any requirement applicable . . . to the device’ under federal law.” 5 Because the Riegels’ state law claims were based on supposed manufacturing, design, and warn- ing defects that imposed such requirements, the Court held that they were preempted. 6 But, Riegel went on to discuss a parallel requirements exception to the general rule of preemption. The Court said that § 360k(a) “does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties * Mark Herrmann is a partner at Jones Day (Chicago, Illinois) and is the author of T HE C URMUDGEON ’ S G UIDE T O P RACTICING L AW (2006), and is co-author of S TATEWIDE C OORDINATED P ROCEEDINGS : S TATE C OURT A NALOGUES TO THE F EDERAL MDL P ROCESS (2d ed. 2004). He co-hosts the Drug and Device Law Blog, http://druganddevicelaw.blogspot.com. From 1997 through 2007, he taught Complex Litigation on the adjunct faculty of Case Western Reserve University School of Law. David Booth Alden is a partner at Jones Day (Cleveland, Ohio), and Bradley W. Harrison is an associate at Jones Day (Cleveland, Ohio). 1. 552 U.S. 312 (2008). 2. Id. at 321–30. Riegel is discussed more fully below. See discussion infra Part II.D. 3. See The Federal Food, Drug, and Cosmetic Act of 1938, ch. 675, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 301–99 (2006)). 4. Medical Device Amendments of 1976, Pub. L. No. 94-295, § 2, 90 Stat. 539, 574 (1976) (codified at 21 U.S.C. § 360k(a)). 5. Riegel , 552 U.S. at 321 (quoting 21 U.S.C. § 360k(a)(1)). 6. Id . at 321–30. 545
\\server05\productn\N\NYS\65-3\NYS307.txt unknown Seq: 2 18-MAR-10 13:28 546 NYU ANNUAL SURVEY OF AMERICAN LAW [Vol. 65:545 in such a case ‘parallel,’ rather than add to, federal requirements.” 7 This parallel requirements exception is far from clear. The Court created the exception twelve years earlier when it first considered the reach of the MDA’s express preemption provi- sion in Medtronic v. Lohr . 8 The Lohr Court observed that: “Nothing in § 360k denies [a state] the right to provide a traditional damages remedy for violations of common-law duties when those duties par- allel federal requirements.” 9 And thus began the hotbed of current litigation involving devices approved through the PMA process. 10 Given that the MDA’s express preemption provision affects (or may affect) most state law product liability claims concerning de- vices approved through the PMA process, the parallel requirements exception described in Lohr and Riegel is a critical issue in those cases. Unfortunately, although the Court has described the parallel requirements exception in cases where it did not apply, the Court has never addressed the exception’s contours or limits in a case in which it applied. 11 Moreover, commentators have focused much of their attention not on explaining how Riegel affected medical device cases, but rather on predicting what the case meant for two later prescription drug preemption cases that came before the Supreme Court— Warner-Lambert Co. v. Kent 12 and Wyeth v. Levine 13 —or ad- 7. Id . at 330 (citing Medtronic v. Lohr, 518 U.S. 470, 495 (1996)). 8. 518 U.S. 470, 495 (1996). 9. Id . at 495. In the concurring portion of her separate opinion, Justice O’Connor (concurring in part and dissenting in part), joined by three justices, added that she “agree[d] that the Lohrs’ claims are not pre-empted by §360k to the extent that they seek damages for Medtronic’s alleged violation of federal re- quirements.” Id . at 513 (O’Connor, J, concurring). Both Lohr and Riegel are dis- cussed in greater detail below. See infra Part II. 10. Cases taking various approaches to the scope of the parallel requirements exception are discussed in Part III.B below. 11. See Riegel , 552 U.S. at 330 (“Although the Riegels now argue that their lawsuit raises parallel claims, they made no such contention in their briefs before the Second Circuit, nor did they raise this argument in their petition for certiorari. We decline to address that argument in the first instance here.”). 12. 552 U.S. 440 (2008) (per curiam) (a non-precedential opinion affirming, by an equally divided court, Desiano v. Warner-Lambert & Co ., 467 F.3d 85 (2006), which held that the fraud-on-the-FDA exception to Michigan’s immunity statute protecting drug manufacturers from liability in products was not preempted by federal law). 13. 129 S. Ct. 1187, 1204 (2009) (federal law did not preempt state law fail- ure-to-warn claims relating to anti-nausea drug). This Article focuses exclusively on preemption in the context of medical devices approved through the PMA pro- cess. Preemption in the context of pharmaceuticals (where there is no express preemption provision), as discussed in Wyeth , is left for another day.
\\server05\productn\N\NYS\65-3\NYS307.txt unknown Seq: 3 18-MAR-10 13:28 2010] THE PARALLEL REQUIREMENTS EXCEPTION 547 dressing preemption more generally. 14 Accordingly, the prevailing thought concerning Riegel is that most state law claims involving de- vices approved through the PMA process are preempted, but plain- tiffs may pursue certain, as-yet-undefined, claims under the parallel requirements exception. 15 Not surprisingly, in Riegel ’s wake, plaintiffs attempt to cast their claims in light of the parallel requirements exception and seek to expand the limits of that exception. But “[l]ittle guidance is pro- vided . . . in Riegel in assessing or determining the nature of parallel claims” that survive preemption. 16 Thus, lower courts have strug- gled to answer the ultimate question: Which state law claims survive preemption under the parallel requirements exception? This Article attempts to answer that question. Part I briefly ex- plains the FDCA, as amended by the MDA, and its regulation of medical devices. Part II examines the Supreme Court’s medical de- vice preemption trilogy: Medtronic, Inc. v. Lohr , 17 Buckman Co. v. Plaintiffs’ Legal Committee , 18 and Riegel v. Medtronic, Inc ., 19 as well as Bates v. Dow Agrosciences LLC , 20 which discussed parallel require- ments claims in relation to the federal pesticide labeling statute. Part III discusses the three major questions courts must address when faced with supposed parallel requirements claims, namely, whether (1) there was a federal violation; (2) the claims are truly parallel; and (3) punitive damages remedies for otherwise parallel claims conflict with federal law. Significantly, many purported parallel requirements claims in- volve situations with no final adjudication of a proceeding initiated by the United States Food and Drug Administration (FDA) that a violation actually occurred. In those instances, the plaintiffs’ at- tempts to pass the threshold for establishing that a claim survives 14. See, e.g ., Richard A. Epstein, The Case for Field Preemption of State Law in Drug Cases , 103 N W . U. L. R EV . 463 (2009); Catherine M. Sharkey, What Riegel Portends for FDA Preemption of State Law Product Liability Claims , 103 N W . U. L. R EV . 437 (2009). 15. See, e.g ., Sharkey, supra note 14, at 450–51; see also The Supreme Court 2007 Term — Leading Cases , 122 H ARV . L. R EV . 405, 412, 414–15 (2008) (concluding that Riegel ’s preemption likely protects only those manufacturers in compliance with FDA regulations). 16. O’Shea v. Cordis Corp., No. 50-2006-CA-013019, 2008 WL 3139428, at *3 (Fla. 4th Dist. Ct. App. May 19, 2008). 17. 518 U.S. 470 (1996). 18. 531 U.S. 341 (2001) (holding that fraud-on-the-FDA claims are impliedly preempted by the FDCA, as amended by the MDA). 19. 552 U.S. 312 (2008). 20. 544 U.S. 431 (2005).
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