By Catherine M. Sharkey[*]
[Editor's Note: This week, we are pleased to present Professor Sharkey's Essay on FDA preemption in light of Riegel v. Medtronic. Part I appears today. Part II of this Essay will appear on Thursday.]
Introduction: Preemption Cases in Search of a Framework
In Riegel v. Medtronic, Inc., the U.S. Supreme Court held that a federal statute governing regulation of medical devices expressly preempts, or displaces, state tort law claims when a device has received FDA premarket approval.[1] A month after the Court issued this opinion, Justice Scalia inveighed against the news media coverage of Riegel (an opinion that he authored) at a meeting convened by the Food and Drug Law Institute:
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Scalia said news organizations often fail to focus on the text of the laws the Court interprets . . . . The media often make it appear as though the court is reaching policy judgments on its own rather than basing its decisions on the text of the law at issue in a case . . . . In some instances, said Scalia, the news media leave the impression that no ruling based on the text of a law “is even possible.”[2] |
Scalia’s majority opinion can indeed be fairly characterized as a “narrow, textual interpretation” of the preemption clause of the congressionally enacted Medical Devices Amendments of 1976 (MDA) to the Federal Food Drug and Cosmetics Act (FDCA).[3] Express preemption cases, at least in theory, can begin and end with statutory text.
But it is rare to find a products liability preemption case where, in Justice Scalia’s words, “the statute itself speaks clearly to the point at issue.”[4] Far more typically, disagreements erupt among the Justices over whether statutory language is in fact clear. Often congressional legislation touches on some aspects of federal regulation of consumer products, motor vehicles, or recreational boats (to name a few examples), without clearly specifying the interrelationship with state common law tort claims. In such legislation, Congress often creates confusion by including both a preemption clause, which mandates displacement of competing or conflicting state law standards, and a savings clause, which purports not to upend existing state common law liability.[5]
Where the language of the preemption and savings clauses points in opposite directions, or where Congress has been cryptic or silent on the matter, Justice Scalia’s ode to text will ring hollow. Courts will have to decide on the basis of implied conflict preemption (as opposed to express preemption), looking at the entire statutory and regulatory framework to determine whether state laws either “make it ‘impossible’ for private parties to comply with both state and federal law,”[6] or, more broadly, whether state laws frustrate or “stand[] as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.”[7] Justice Ginsburg’s lone dissent in Riegel may well portend the true battleground in implied conflict preemption challenges to come: “In the absence of legislative precision . . . courts may face the task of determining the substance and scope of Congress’ displacement of state law.”[8] Where statutory text is indeterminate, where are courts to look?
Several options present themselves. First, courts may resort to the “presumption against preemption” statutory canon to raise the bar against interpretations favoring preemption absent clear language by Congress.[9] While this approach retains some appeal for judges and academic commentators,[10] it has receded of late in the imagination of the Supreme Court Justices. In fact, this canon was not even mentioned by the majority in Riegel.[11]
Second, perhaps—consistent with the media suggestion about Riegel—the Justices simply vote their policy preferences in these matters.[12] If so, then we would expect even more room for judicial policymaking in implied preemption cases, where Congress has not restricted courts’ interpretive sphere with constraining statutory language. In one sense, preemption decisions always entail policy choices. After all, the decision that a federal standard ousts a competing state standard entails a choice that regulation should take place exclusively at the federal level, and a concomitant embrace of the view that state tort law is a regulatory competitor. Riegel subscribes to this ascendant law-and-economics inspired view of the regulatory role of tort law;[13] the opposing “tort as compensation” view is nowhere engaged.[14]
Justice Scalia’s majority opinion goes even further down this road, casting aspersions on the jury’s competence to engage in cost-benefit analysis, relative to that of the FDA.[15] And in a passage distinctly out of place in an opinion whose outcome is ostensibly determined exclusively by statutory text, Justice Scalia, “speculat[ing] upon congressional motives,” finds a “suggest[ion] that the solicitude for those injured by FDA-approved devices . . . was overcome in Congress’s estimation by solicitude for those who would suffer without new medical devices if juries were allowed to apply the tort law of 50 states to all innovations.”[16]
When such policy predilections undergird
preemption decisions—even, as in Riegel,
in the narrowest realm of express preemption based upon clear statutory text,
let alone in the comparatively unbounded realm of implied preemption—it is time
to consider alternative models to that of courts’ being left to their own
devices under the guise of imputing congressional motives.
This Essay presents that alternative, building
upon my previously articulated “agency reference model,” which provides a
framework for courts to decide implied conflict preemption cases by
seeking guidance from the relevant federal regulatory agency.[17]
The basic question at the core of implied
conflict preemption inquiries is whether or not state common law
actions are
irreconcilable with, or would stand as an obstacle to, or frustrate,
the
command of federal regulatory directives and goals. To answer this
question, courts need a
fine-grained account of the precise regulatory review conducted by the
agency
and evidence as to its compatibility with state law tort claims. The
agency reference model aims, as a general matter, to facilitate input
from federal agencies on these issues.
As the Court moves beyond Riegel and the realm of express preemption to tackle implied
conflict preemption in the pharmaceutical context in the upcoming Wyeth v. Levine case,[18] the time is ripe to consider such a
model. Indeed, where, by
definition, statutory text alone will not resolutely decide the implied
conflicts in products liability cases, articulation of an analytic framework
for where the courts should turn is a pragmatic necessity. Drawing upon some suggestive gestures toward
agency input in Riegel, this Essay
applies the agency reference model to the concrete setting of the regulation of
pharmaceutical drugs and extends the model by specifying searching judicial
review of evidence taken from the FDA’s regulatory record (record evidence) to
substantiate FDA findings of implied conflicts between state common law
failure-to-warn claims and the federal regulation of the safety and efficacy of
drugs.
I. Agency Input
Judicial reliance on input from federal agencies in making preemption decisions is not as radical as it might at first seem. Indeed, although often barely acknowledged, reliance on agencies’ views in regulatory preemption cases has been a staple of Supreme Court jurisprudence.[19] Riegel fits this pattern of cryptic reliance on agency positions. For, although ultimately decided as an express preemption case based on unambiguous statutory text, Riegel nonetheless gives a nod toward agency deference, suggesting that, had the statute been ambiguous, the Court would have taken into account the FDA’s position on preemption.
Riegel provided the Court a second opportunity to interpret the preemption provision of the Medical Devices Amendments to the FDCA. The earlier case, Medtronic v. Lohr,[20] likewise an express preemption case, thus presents a foil to Riegel. To begin, the Court reached the opposite bottom line conclusion on preemption in Lohr, so the differences between the two cases can be probed for salient preemption factors. More fundamentally, Lohr’s acknowledgement of “[t]he ambiguity in the statute,” and concomitant reliance upon “the agency’s view of the statute,”[21] places Riegel’s paeon to statutory text in sharp relief.
Given its finding of statutory ambiguity in the MDA, Lohr ventured part way down the implied preemption path, acknowledging that the FDA “is uniquely qualified to determine whether a particular form of state law ‘stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress’”[22] Considering Lohr and Riegel together provides not only an opportunity to examine how the Court has previously taken into account agency input in a medical device preemption case, but also an occasion to provide guidance on how the Court should use agency input, not only in express preemption cases, but perhaps even more significantly, in implied preemption cases, such as the upcoming Wyeth pharmaceutical case.
Section A focuses on the agency’s preemption position, expressed in the form of enacted regulations or other more informal statements, ultimately concluding that although such statements are useful, the Court’s focus should be instead on how regulations are actually administered by the agency. Section B turns to this administration, proposing that, when trying to determine whether or not state law should be preempted by federal agency action, courts should look to the regulatory record to determine whether or not an agency actually considered the risks that the state law attempts to protect against.
A. Preemption Position
Agencies have a variety of means at their disposal to express their position on preemption, from notice-and-comment rulemaking to less formal interpretive statements, preambles to rules, and litigation briefs.[23]
1. Regulations.—The Lohr majority’s interpretation of the MDA’s express preemption provision was “substantially informed” by an FDA regulation.[24] The FDA had issued a regulation construing the scope of the preemption provision, which sharply cabined its preemptive force.[25] The FDA took the further position that the MDA “does not preempt State or local requirements of general applicability where the purpose of the requirement relates . . . to other products in addition to devices.”[26] The Lohr Court relied on these interpretations in finding that the FDA’s premarket notification process did not amount to device-specific preemptive requirements.[27]
In contrast, the majority in Riegel toed the textualist statutory interpretation line, concluding that “the [same FDA] regulation fails to alter our interpretation of the [statutory] text insofar as the outcome of this case is concerned.”[28] But, “[e]ven assuming that this regulation could play a role in defining the MDA’s pre-emptive scope,” and recognizing that “[t]he agency’s reading of its own rule is entitled to substantial deference,”[29] the Court nonetheless dispensed with the FDA’s interpretation of its regulation, finding its reasoning “less than compelling.”[30]
The most striking feature here is the Riegel majority’s equivocation with respect to whether courts should generally take into account the FDA’s interpretive gloss. The Court “[n]either accept[s] nor reject[s] the proposition that this regulation can be properly consulted to determine the statute’s meaning.”[31] Most likely, the equivocation was necessary to carry an eight-Justice majority and masks a sharper division among the Justices on the issue, likely to rear its head once statutory text can no longer provide cover.[32]
2. Informal Statements.—Agencies also state their positions on preemption through amicus briefs, preambles to regulations, and other informal statements. In Riegel, although the majority does not cite the FDA’s amicus brief directly, it does make note of the brief by acknowledging the FDA’s support of the majority’s pro-preemption position.[33]
Court reliance upon agency amicus briefs and preambles to rules presents a challenge to notions of appropriate administrative deference. While briefs and preambles arguably lack “the force of law” necessary to warrant Chevron mandatory deference,[34] the doctrine on deference to agency preambles and amicus briefs—particularly in the realm of preemption—is far from clear. Justice Breyer has staked out the position that not only should an agency’s position on preemption be given deference in the face of an ambiguous congressional command, but also that the agency can communicate that position informally “through statements in ‘regulations, preambles, interpretive statements, and responses to comments.’”[35]
Justice Breyer’s strong-form deference to agencies is guided by his conviction that agencies have a “special understanding of the likely impact of both state and federal requirements, as well as an understanding of whether . . . state requirements may interfere with federal objectives.”[36] The thrust of my argument in this Essay is that courts should subject this “wholesale” observation to scrutiny at the “retail” level of agency regulatory action. The record evidence developed by the agency, to which I turn next, should be critical in courts’ preemption decisions.
B. Regulatory Record
Particularly when called upon to answer whether state law frustrates, or stands as an obstacle to, the federal regulatory framework, instead of relying on agency interpretation or general position on preemption—which not only might fall outside the expertise of agencies, but can also be influenced by inappropriate political considerations—courts should focus on the regulatory record of the agency.[37]
Riegel is rife with details from the FDA’s regulatory review process—though their precise legal effect, given the Court’s insistence on governing statutory text, is rather opaque. The Court drills down to the details of the FDA’s review process, repeatedly stressing the “rigorous” nature of its premarket approval (PMA) process for medical devices.[38] This PMA process demands considerable resources and manpower hours, culminating in the FDA’s determination of “reasonable assurance” of the medical device’s “safety and effectiveness.”[39]
The contrast between FDA’s PMA process (at issue in Riegel) and its premarket notification process (at issue in Lohr) is twofold. Premarket notification is a streamlined process, which is completed in an average of 20 hours (as compared to the PMA’s 1,200-hour average).[40] So, measured by average manpower hours, this type of regulatory review is sixty times more lax. Even more germane is the distinction the Court draws between the FDA’s premarket notification “equivalence” review, which essentially “grandfathers” devices that are equivalent to those existing on the market at the time of the MDA’s enactment,[41] versus the full-blown PMA “safety” review.[42]
In the Riegel Court’s view, the details of the FDA’s stringent safety review are relevant to the Court’s interpretation of the MDA. The Court emphasizes that premarket approval is a safety review, and as such imposes “requirements” under the MDA.[43] But the significance of the FDA’s level of regulatory scrutiny of medical devices to the regulatory preemption inquiry is even more far reaching and could prove influential, if not dispositive, in resolving implied conflict preemption disputes, where courts must look beyond the statutory text to decide whether or not state common law actions obfuscate or impede federal regulatory directives and goals.
While the Riegel opinion does not pursue this line of inquiry, several of the Justices tipped their respective hats in this direction during oral argument. Justice Kennedy proffered a concise statement of implied conflict: “The FDA is specifically charged [in the PMA process] with weighing the [potential] risks [of injury and illness] against the probable benefits [to the health of the patient]. . . . So the jury is doing the same thing that the FDA did.”[44] Justice Scalia seemed to be of like mind, forging a distinction between Lohr and Riegel on the basis of whether the jury was engaged in the same regulatory function as the FDA: “[T]he point is that the FDA in Lohr had never made a determination of weighing the risks against the benefits, as they do for the issuance of PMA’s. And so the jury was not replowing the same ground that the FDA had already plowed in Lohr.”[45]
The Justices’ queries here point in exactly the right direction—namely, when it comes to making an implied conflict preemption determination, it is critical to discern whether the FDA has weighed in on the precise risk the state tort action likewise seeks to regulate. Such a framework will focus judicial attention on the regulatory record compiled by the agency, contemporaneously with its decision whether or not to take regulatory action.
————
*. Professor of Law, New York University School of Law. Kristen Richer provided helpful research assistance.
2. Scalia Criticizes News Media, Associated Press, Mar. 27, 2008, available at http://www.breitbart.com/article.php?id=D8VM047O4&show_article=1 (link).
3. Robert Barnes, Supreme Court Shields Medical-Device Makers, Wash. Post, Feb. 21, 2008, at D1, available at http://www.washingtonpost.com/wp-dyn/content/article/2008/02/20/AR2008022001140.html (quoting Catherine Sharkey, Professor of Law, New York University School of Law) (link). The MDA expressly preempts state requirements that are “different from, or in addition to” certain federal requirements. 21 U.S.C. § 360k(a) (2006) (link).
4. Riegel, 128 S. Ct. at 1009. Indeed, even with respect to the MDA, the Court interpreted the very same preemption clause in Medtronic, Inc. v. Lohr, where it found substantial “ambiguity in the statute.” 518 U.S. 470, 496 (1996) (citation omitted) (link). See infra note 21 and accompanying text.
5. See National Traffic and Motor Vehicle Safety Act of 1966, 15 U.S.C. § 1392(d) (1988) (current version at 49 U.S.C. § 30103(b) (2000) (link)) (preemption clause); id. § 1397(k) (current version at 49 U.S.C. § 30103(e) (2000) (link)) (savings clause); Consumer Product Safety Act, 15 U.S.C. § 2075(a) (2000) (preemption clause) (link); id. § 2074(a) (savings clause) (link); Federal Boat Safety Act of 1971, 46 U.S.C. § 4306 (2000) (preemption clause) (link); id. § 4311(g) (savings clause) (link).
8. Riegel, 128 S. Ct. at 1014 (Ginsburg, J., dissenting); see also Lohr, 518 U.S. at 505 (Breyer, J., concurring) (“Congress must have intended that courts look elsewhere for help as to just which federal requirements pre-empt just which state requirements, as well as just how they might do so.”).
9. The presumption harkens back to mid-twentieth century, when the Court asserted that “the historic police powers of the States [a]re not to be superseded . . . unless that was the clear and manifest purpose of Congress.” Riegel, 128 S. Ct. at 1013 (Ginsburg, J., dissenting) (alterations in original) (quoting Rice v. Sante Fe Elevator Corp., 331 U.S. 218, 230 (1947)).
10. See, e.g., Brief of Amicus Curiae Constitutional and Administrative Law Scholars in Support of Respondents at 3–4, Philip Morris USA Inc. & Altria Group, Inc. v. Good, No. 07-562 (U.S. June 18, 2008), 2008 WL 2489869, at *3–4 (“[S]tatutory rules like this Court’s ‘presumption against preemption’ are the most critical component of this Court’s federalism doctrine. . . . [and] suggest a lens through which this Court should view preemption disputes.”) (citation omitted).
11. Nor can its absence be explained by the fact that Riegel is an express preemption case, for so was Lohr, and there, the Court trotted out the trusted presumption as the opening salvo of its preemption analysis. Lohr, 518 U.S. at 485 (“[B]ecause the States are independent sovereigns in our federal system, we have long presumed that Congress does not cavalierly pre-empt state-law causes of action.”). In fact, to date, the Court has—paradoxically—applied the presumption in the express preemption products liability cases, but not in the implied ones. See Catherine M. Sharkey, Products Liability Preemption: An Institutional Approach, 76 Geo. Wash. L. Rev. 449, 458 (2008) [hereinafter Sharkey, Products Liability Preemption] (noting that the Court invoked the presumption in Bates v. Dow Agrosciences LLC, 544 U.S. 431 (2005), Lohr, and Cipollone v. Liggett Group, Inc., 505 U.S. 504 (1992)—all decided on express preemption grounds—but not in Sprietsma v. Mercury Marine, 537 U.S. 51 (2002), or Geier—the seminal implied preemption cases) (link).
12. The standard attitudinal model used by political scientists posits that Justices vote their policy preferences. See Jeffrey A. Segal & Harold J. Spaeth, The Supreme Court and the Attitudinal Model Revisited 86 (2002); see also Saul Brenner & Harold Spaeth, Stare Indecisis: The Alteration of Precedent on the Supreme Court, 1946–1992, at 109 (1995).
13. Riegel, 128 S. Ct. at 1008 (“[W]hile the common-law remedy is limited to damages, a liability award ‘can be, indeed is designed to be, a potent method of governing conduct and controlling policy.’”) (citing Cipollone, 505 U.S. at 521).
14. Justice Stevens, champion of the remedial function of tort law in Lohr, see 518 U.S. at 487–89, though conceding that “the overriding purpose of the [FDCA] was to provide additional protection to consumers,” says nothing further about the disappearance of the tort-as-compensation model in Riegel. See 128 S. Ct. at 1011–13 (Stevens, J., concurring in part and concurring in the judgment). Nor does Justice Kennedy, who dissented in Cipollone, in part on the ground that on the ground that “tort law has an entirely separate function—compensating victims—that sets it apart from direct forms of regulation,” 505 U.S. at 537, express any hesitation on that front in joining the Riegel majority.
15. Riegel, 128 S.Ct at 1008 (“A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court.”). See also Transcript of Oral Argument at 19, Riegel, 128 S. Ct. 999 (No. 06-179) [hereinafter Riegel Oral Argument], available at http://www.supremecourtus.gov/oral_arguments/argument_transcripts/06-179.pdf (Scalia, J.) (“What’s going on is simply one jury has decided that in its judgment, there was a safer device that should have been used; and because of the judgment of that one jury, the manufacturer is placed at risk in selling a device that scientists at the FDA have said is okay. I find that extraordinary.”) (link).
16. Riegel, 128 S. Ct. at 1009. Here, Justice Stevens jumped off the majority bandwagon, rejecting this “policy argument advanced by the Court, not by Congress.” Id. at 1012 (Stevens, J., concurring in part and concurring in the judgment).
17. Sharkey, Products Liability Preemption, supra note 11, at 452–53, 477–502 (setting forth a functional institutional approach to implied conflicts products liability preemption whereby courts accord Skidmore deference to agency preemption determinations, conditioned on strong record evidence concerning regulatory cost benefit analysis and a reasoned determination of the need for a uniform national policy).
18. 128 S. Ct. 1118 (No. 06-1249), cert. granted, 76 U.S.L.W. 3018 (U.S. Jan. 18, 2008) (to be argued October Term 2008). The Court will consider “[w]hether the prescription drug labeling judgments imposed on manufacturers by the [FDA] pursuant to FDA’s comprehensive safety and efficacy authority under the [FDCA] preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use.” Supreme Court of the United Strates, Question Presented for Wyeth v. Levine, available at http://origin.www.supremecourtus.gov/qp/06-01249qp.pdf (link).
19. See Sharkey, Products Liability Preemption, supra note 11, at 471–72.
21. Id. at 496 (“The ambiguity in the statute . . . provide[s] a sound basis for giving substantial weight to the agency’s view of the statute.”) (citations omitted) (quoting id. at 509 (O’Connor, J., dissenting)).
22. Id. (quoting Hines v. Davidowitz, 312 U.S. 52, 67 (1941)).
23. For a discussion of the recent trend of agencies’ issuance of “preemption preambles” to regulations, see Catherine M. Sharkey, Preemption by Preamble: Federal Agencies and the Federalization of Tort Law, 56 DePaul L. Rev. 227 (2007) [hereinafter Sharkey, Preemption by Preamble].
24. Lohr, 518 U.S. at 495.
25. Exemptions from Federal Preemption of State and Local Medical Device Requirements, 21 C.F.R. § 808.1(d) (2007) (restricting preemption to instances where FDA had established “specific counterpart regulations or . . . other specific requirements applicable to a particular device”).
26. Id. § 808.1(d)(1) (listing, as examples, general electrical codes, the Uniform Commercial Code’s warranty of fitness and unfair trade practices).
27. See Lohr, 518 U.S. at 501.
28. Riegel v. Medtronic, Inc., 128 S. Ct. 999, 1011 (2008) (“All in all, we think that [the FDA regulation] can add nothing to our analysis but confusion.”) (link).
29. Id. at 1010 (citing Auer v. Robbins, 519 U.S. 452, 461 (1997)).
30. Id. In the end, the Court hedges by “neither accepting nor rejecting the FDA’s” position in light of the Court’s exclusive reliance upon statutory text. Id. at 1011.
31. Id.
32. Past decisions shed some light here. Justices Scalia and Thomas (as well as then-Chief Justice Rehnquist) joined Justice O’Connor’s withering critique of the Lohr majority’s reliance upon FDA regulations to “inform” its statutory interpretation. Lohr, 518 U.S. at 512 (O’Connor, J., concurring in part and dissenting in part) (“It is not certain that an agency regulation determining the pre-emptive effect of any federal statute is entitled to deference . . . .”). Wachovia Bank, N.A. v. Watters, 127 S. Ct. 1559 (2007), is also instructive. In that case, the majority held that state laws were preempted by the National Banking Act, thereby dodging the issue (on which the Court had granted certiorari) whether the interpretation of the Comptroller of the Currency was entitled to Chevron deference. Id. at 1572. Chief Justice Roberts and Justice Scalia joined Justice Stevens’s vigorous dissent arguing that, despite the majority’s protestations to the contrary, “this is a case about an administrative agency’s power to preempt state laws” and “[n]o case from this Court has ever applied such a deferential standard to an agency decision that could so easily disrupt the federal-state balance.” Id. at 1584–85 (Stevens, J., dissenting).
33. See Riegel, 128 S. Ct. at 1009 (“In the case before us, the FDA has supported the position taken by our opinion with regard to the meaning of the statute.”).
34. See Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984) (link); United States v. Mead Corp., 533 U.S. 218, 228 (2001) (link); see also Thomas W. Merrill, The Mead Doctrine: Rules and Standards, Meta-Rules and Meta-Standards, 54 Admin. L. Rev. 807 (2002) (seeking a model through which courts may decide whether an agency action carries the “force of law”) (link).
35. Lohr, 518 U.S. at 505–06 (Breyer, J., concurring).
36. Id. at 506 (Breyer, J., concurring).
37. In this respect, I agree, at least in part, with both Richard Epstein’s and Richard Nagareda’s trenchant analyses of FDA tort preemption to the extent that each has urged an approach centered upon the agency’s regulatory action. See, e.g., Richard A. Epstein, Why the FDA Must Preempt Tort Litigation: A Critique of Chevron Deference and a Response to Richard Nagareda, 1 J. Tort. L. art. 5, at 20, available at http://www.bepress.com/jtl/vol1/iss1/art5/ (2006) (“Did the agency make a considered examination of the various risks when it decided on its course of action?”) (link); Richard Nagareda, FDA Preemption: When Tort Law Meets the Administrative State, 1 J. Tort L. art.4, at 5, available at http://www.bepress.com/jtl/vol1/iss1/art4/ (2006) (advocating an approach “seeking to marry a proper understanding of preemption with appropriate design of the underlying regulatory regime”) (link).
But, as usual, the devil resides in the details—namely what constitutes an agency’s “considered examination” of the precise risks at issue and what level of judicial review—of agency interpretations, actions, and inaction—should pertain? Here is where, I think, I push the ball several lengths forward.
38. Riegel, 128 S. Ct. at 1003–04.
39. Id. at 1004.
40. Lohr, 518 U.S. at 478–79.
41. Id. at 480 (noting that the FDA’s “substantial equivalence” letter to the manufacturer “emphasized . . . that this determination should not be construed as an endorsement of the pacemaker lead’s safety”).
42. Riegel, 128 S. Ct. at 1004 (describing the safety review process that calls upon the FDA to “weig[h] any probable benefit to health from the use of the device against any probable risk of injury or illness from such use”) (alteration in original) (internal quotation marks omitted).
43. Id. at 1007. There is a logic to this progression of reasoning, namely: “the FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application, for the reason that the FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness.” Id.
44. Riegel Oral Argument, supra note 15, at 6–7.
45. Id. at 8. Justice Alito, too, asked questions in this same vein. Id.at 30–32.
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Copyright 2008 Northwestern University
Cite as: 102 Nw. U. L. Rev. Colloquy 415 (2008).
Persistent URL: http://www.law.northwestern.edu/lawreview/colloquy/2008/24
(Comments)
I look forward to the next installment. This is powerful.
Just this clarifying quetion for Professor Sharkey:
If I follow you, you are moving beyond the preemption vs. no-preemption debate via the issue of the regulatory history of a specific product. This arises clearly in Wyeth v. Levine, where the history is complex and abundant.
So does it follow that the SC could rule rather narrowly in Levine, upholding preemption in cases where there has been extensive FDA review ("extensive" being always open to interpretation) but not necessarily where damage is claimed by a feature of the product essentially not reviewed by FDA (e.g., because not considered relevant, because relevant data somehow delayed or misrepresented, etc.)?
Am I getting the gist?
Thank you.
Posted by: Hanoch Greenspan | July 21, 2008 at 11:50 AM
Hanoch: Yes, you are getting the gist of my argument, which will unfold in more detail in the next installment on Thursday (and will include an application to the upcoming Wyeth case). Let me say for now that you put your finger on an insight that has a further institutional dimension: namely, because (as you intuit) my approach to preemption is, in some sense, a "middle ground" position between the extremes of all-or-nothing preemption, it is less likely that Congress (alone) could arrive at the "right" answer by adding an express preemption (or anti-preemption) clause directly into the relevant statute. Hence, agencies not only do (by default, where Congress has not been clear)--but, as a normative matter, should--play a key role in preemption decisions. The debate, then, shifts (appropriately, to my mind) to defining the parameters for legitimate agency claims to authority both for its substantive determinations and for its interpretation of the statute.
Posted by: Catherine Sharkey | July 21, 2008 at 02:02 PM