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 II appears today.]
II. Judicial Review
The Riegel majority had little to say about judicial review of agency actions or interpretations, given the primacy and determinacy of statutory text to the question at hand. But what little the Court did have to say may have resolved (at least in dicta) a simmering debate over the appropriate level of deference due to agency views on preemption:
In the case before us, the FDA has supported the position taken by our opinion with regard to the meaning of the statute. We have found it unnecessary to rely upon that agency view because we think the statute itself speaks clearly to the point at issue. If, however, we had found the statute ambiguous and had accorded the agency’s current position deference, the dissent is correct that—inasmuch as mere Skidmore deference would seemingly be at issue—the degree of deference might be reduced by the fact that the agency’s earlier position was different.
Wrapped up in this quixotic counterfactual musing are two salient doctrinal points: first, that “mere Skidmore” deference—which is meted out according to the agency’s “power to persuade” the court, as opposed to unconditionally—is the appropriate level of judicial deference; and second, that agency inconsistency is a salient factor, weighing against an agency’s new-found (and by hypothesis, turn-about) position. What is missing is a framework for the Court to undertake judicial review, probing the adequacy of the reasons given by the agency for taking a particular action, as well as for changing tack and taking a different course of action.
A. Applying Skidmore Deference
Skidmore deference trains the court’s review of an agency’s interpretation on “all those factors which give it power to persuade, if lacking power to control,” such as “the thoroughness evident in its consideration, the validity of its reasoning, [and] its consistency with earlier and later pronouncements.” Perhaps the sole point of agreement between the majority and dissent in Riegel was that if Skidmore deference were to apply, then the court should consider whether the FDA’s position on preemption merited less deference on account of its inconstancy.
Twelve years before Riegel, under the Clinton administration, the FDA publicly endorsed an anti-preemption position vis-à-vis the MDA’s regulation of medical devices. Before the Court in Lohr, the FDA put forward a narrow view of its preemptive power, emphasizing the manufacturer’s ultimate responsibility for its design of medical devices. And the year following Lohr, in an amicus brief urging the Court to grant certiorari in another medical devices case (where the catheter device at issue had gone through the full PMA process), the FDA took the position that the MDA’s preemption provision is not preemptive.
Fast forward to the Bush II administration. The FDA did a seeming 180-degree turn-about and first articulated its new pro-preemption position for PMA devices in 2004 in an amicus brief in Horn v. Thoratec, a case before the Third Circuit Court of Appeals. The FDA argued that the PMA process creates specific federal requirements because, following approval, the manufacturer cannot alter the design or labeling of the device without FDA approval.
Sweeping Chevron deference to agencies on preemption questions raises the troubling specter of enabling or encouraging cycles of agency political flip-flop, and, more generally, of foregoing a key judicial check by relieving the agency of responsibility to supply an adequate record to substantiate its position regarding the preemptive effect of federal statutes and regulations. Riegel could in fact be hypothetical “exhibit A.” The FDA’s change in position did not escape notice in Riegel. Justice Stevens drew attention to it during oral argument. And Justice Ginsburg hammered the point home that the FDA’s previous position “was 180 degrees different.” Stipulation of the weaker Skidmore deference standard still leaves much to be decided. Namely, how should a court determine whether the agency’s change in position has been reasonably explained?
B. Demanding Reasonable Explanations
In the Riegel opinion below, the Second Circuit was little troubled by the FDA’s change of heart; the court explained: “It is certainly true that the FDA previously took a different view, but as the Third Circuit noted in Horn, ‘an agency may change its course so long as it can justify its change with “reasoned analysis,”‘ a standard satisfied here.” But the FDA provided little more than an ipse dixit justification of its change in position in Horn, based upon its “further analysis of the relevant legal and policy issues” as well as recent contrary court decisions.
In its amicus brief filed at the petition stage at the Supreme Court, the Solicitor General added only that “[t]he government’s [previous anti-preemption] position . . . is also inconsistent with the risk-management principles that the FDA currently follows.” The government seemed to rely heavily on the notion that its position is entitled to substantial deference and that its explanation of “risk-management principles” and “the need to prevent over-warning” should suffice to demonstrate the incompatibility of state tort law with the FDA regulatory standards.
The government’s proffers based solely on its “judgment” or new policy preferences—of the sorts offered in Horn and Riegel—should not pass judicial muster in implied conflict preemption cases. Instead, courts should apply searching review and require direct, hard evidence from the agency’s regulatory record of how state common law conflicts with the federal regulatory scheme and, where applicable, the basis for any change in agency position. Justice Alito made a gesture in this direction, when he asked during the Riegel oral argument whether the PMA regulatory record would reflect whether the precise design defect complained of by petitioner was considered by the FDA. The informational demands of such an approach are significant, which perhaps explains why it has been resisted by the FDA.
The Riegel Court did not have to squarely face these issues of appropriate deference to the FDA, or judicial review of the bases for its preemption position, given the Court’s exaltation of statutory text. The Court, moreover, declined to venture down the implied conflict preemption path, where it might have taken account of, and accorded Skidmore deference to, the FDA’s preemption position, the basis for which it would then subject to some level of judicial scrutiny. These issues are sure to rear their head in future challenges before the Court.
III. Future Challenges: Pharmaceuticals
In the wake of Riegel, what will the state law products liability landscape look like? Riegel certainly narrows the scope of state law claims of allegedly defective FDA-approved medical devices that can withstand a federal preemption challenge. That said, claims of tort litigation’s demise in the arena of medical devices, let alone all of products liability, have been overstated.
Four caveats to the Court’s opinion suggest categories of surviving claims. First, manufacturing defect (as distinct from design defect and failure to warn) claims are allowed to proceed. Second, keeping in mind the distinction between Riegel, which addressed itself to devices that were approved via the FDA’s PMA process, and Lohr, which pertained to devices that had secured approval via the FDA’s “substantial equivalence” premarket notification process, only manufacturers of medical devices that enter the market via PMA (at present, roughly ten percent of relevant devices) can use the shield of Riegel to stave off state tort claims using a preemption defense. A third important caveat involves negligence per se actions—state tort law actions based upon the violation of a federal regulatory standard. The Riegel majority is explicit that “the state duties in such a case ‘parallel,’ rather than add to, federal requirements” and are thus not preempted. Finally, there may be an additional opening for situations where new product risks come to light after the FDA’s initial approval. What Riegel portends for the future may, nonetheless, lie more in the questions left unanswered, or at least not fully answered.
Pharmaceutical litigation involving FDA-approved drugs lies just over the Court’s horizon. Indeed, when the Court heard argument in Riegel, the specter of the upcoming FDA pharmaceutical preemption case, Wyeth v. Levine, loomed large in the background. During the Riegel oral argument, Justice Scalia turned from devices to drugs, asking (seemingly rhetorically): “Then the States can issue regulations that go beyond—beyond what the FDA says in drug matters? I would be surprised if that’s the case.”
When the Court ruled 8-1 in favor of preemption in Riegel, some preemption enthusiasts seemed poised to celebrate an FDA preemption “hat-trick” at the Supreme Court—with impending victories in the two pharmaceutical preemption cases to come, Kent v. Warner-Lambert, a fraud-on-the-agency case also decided last Term, and Wyeth. The eight-person majority, after all, rose against Justice Ginsburg’s lone dissenting voice to clarify that “[i]t has not been established (as the dissent assumes) that no tort lawsuits are pre-empted by drug or additive approval under the FDCA.” But selective parsing of Court opinions has its perils. For, far from intimating that its decision in Riegel would preordain the same result in the pharmaceutical context, the Court emphasized a key statutory distinction between the realms of medical devices and drugs: a preemption clause applies to the former, but not the latter. The whole game, then, switches from express preemption in Riegel to implied conflict preemption in Wyeth. Moving the battleground from express preemption (in medical devices context) to implied preemption (in pharmaceutical context) is likely to divide the ranks, as was the case in Kent, where the Court handed down its 4-4 split decision (with Justice Roberts’ having recused himself).
Certainly with statutory text unable to take up the gauntlet to resolve the preemption question, issues that lurked in the background of Riegel come decidedly to the fore. The presumption against preemption may once again rear its head (although quiescent in Riegel) and policy preferences could reveal themselves in the guise of pronouncements on the compatibility of ex ante FDA regulation of drugs with ex post juror resolution of state tort claims. But all eyes should be trained on the Court’s treatment of the FDA’s involvement.
A. FDA Input
Recall that Riegel can be distinguished from Lohr on the basis of the rigor of the PMA process at issue in the former as compared to the premarket notification process in the latter. The Riegel dissent carries this line of analysis into pharmaceuticals, making the point that “the process for approving new drugs is at least as rigorous as the [PMA] process for medical devices.” Justice Ginsburg means for this to be a strike against reliance upon the rigor of FDA regulatory review, staking her argument on the claim that courts have not found that FDA approval of drugs preempts state tort lawsuits. The Riegel majority instead takes the rigor of the device approval process to support its pro-preemption interpretation of the MDA.
As I suggested above, the significance is even greater in the realm of implied conflict preemption analysis, where the question whether allowance of state tort law claims enables a jury to “redo” the very same cost-benefit analysis conducted by the agency is relevant to a court’s consideration of whether state tort law impedes the federal regulatory process. With this in mind, the details of the FDA drug approval process provided by Justice Ginsburg take on an added significance. As summed up by the Solicitor General in Riegel, “FDA’s risk-benefit balancing for devices is parallel to the risk-benefit balancing it undertakes . . . as part of the pre-market approval process for drugs.”
Further questions must be asked, however, in the context of drugs, which is governed by implied conflict preemption analysis: Does FDA regulation (including rigorous approval processes ensuring the safety and efficacy of drugs) constitute a minimal safety “floor” or an optimal level of protection, and thus a regulatory “ceiling” as well? Even if the latter, which precise risks (costs) has the FDA considered and weighed in on in the course of its risk-benefit balancing? Only then can we know whether allowing state tort claims to proceed when FDA-approved drugs cause harm will obstruct the federal regulatory process.
Chief Judge Reiber, the dissenting judge in the Wyeth lower court opinion, perceived such a conflict. To him, the issue was fairly clear-cut: “FDA concluded that the drug—with its approved methods of administration and as labeled—was both safe and effective,” whereas the “jury concluded that the same drug—with its approved methods of administration and as labeled—was ‘unreasonably dangerous.’” But the Wyeth majority embraced the view that the FDA standards were minimal ones, rife for enhancement by state tort law. The majority’s interpretation is buttressed by the literal language of an FDA regulation, known as the “changes being effected” (CBE) regulation, that seems to permit drug manufacturers to add or strengthen FDA-approved warnings, at least in certain circumstances. In 1979, moreover, the FDA said that its regulations did not prohibit labeling changes made to add or strengthen warnings without prior FDA approval.
Today, the FDA takes the interpretive position that the CBE should be read to apply only to “newly discovered risks”—although those words do not appear in the regulation. The FDA relies upon its policy not to take enforcement action against a manufacturer that modifies a label absent FDA approval in light of newly discovered risk information. Recently, the FDA has proposed a rule to codify what it says is the “agency’s longstanding view.” The FDA argues that any broader interpretation, which would allow manufacturers unilaterally to add new warnings to drugs would “undermine the FDA approval process required by Congress.” The FDA thus wants to circumscribe the domain of unilateral manufacturer labeling activity to what it defines as “newly discovered risks.” The Solicitor General has pressed this view before the Supreme Court in Wyeth.
The FDA’s new proposed rule is of a piece with its earlier 2006 “preemption preamble” to a rule on the content and format of drug labels, which sets forth the FDA’s belief that “FDA approval of labeling under the act . . . preempts conflicting or contrary State law.” In the preamble, the FDA asserts that “product liability lawsuits have directly threatened the agency’s ability to regulate manufacturer dissemination of risk information for prescription drugs in accordance with the [FDCA].” In both the earlier preemption preamble and the recent proposed CBE regulation, the agency squarely takes the position that the new drug approval process, culminating in the FDA’s finding that a drug is “safe and effective” under the conditions as stated in its labeling constitutes optimal, or ceiling, safety standards, as opposed to minimal, or floor, ones. According to the FDA, “[t]he centerpiece of risk management for prescription drugs generally is the labeling which reflects thorough FDA review of the pertinent scientific evidence.”
B. Judicial Review
The potential clash between federal regulation and state tort law is premised upon the FDA’s claim—as put forward in its preemption preamble, the proposed CBE regulation, and in the Solicitor General’s amicus brief in Wyeth—that the agency is engaged in setting optimal, as opposed to minimal, standards. As I have emphasized, input from the relevant agency on the question of interference with federal regulatory schemes is critical for courts to make implied conflict preemption decisions. But, equally important, courts must scrutinize the bases for agency’s claims and determinations.
The FDA’s main concern with allowing state tort claims on top of FDA regulation of drug labels is the risk that overwarning can harm patients and interfere with regulatory goals. In its preemption preamble, the FDA claimed that “additional requirements for the disclosure of risk information are not necessarily more protective of patients” and cautioned that an overabundance of warnings “can erode and disrupt the careful and truthful representation of benefits and risks that prescribers need to make appropriate judgments about drug use.” The nefarious effects of overwarning induced by state tort liability are (at least) two-fold. First, there is the risk of warning dilution, namely, “labeling that includes theoretical hazards not well-grounded in scientific evidence can cause meaningful risk information to lose its significance.” Second, “[e]xaggeration of risk, or inclusion of speculative or hypothetical risks, could discourage appropriate use of a beneficial drug.” In sum, according to the FDA, “where warnings are concerned, more is not always better.”
The FDA preemption preamble suffers from serious procedural irregularities, including the fact that in the original notice of proposed rulemaking, the FDA stated that its proposed rule would not preempt state tort law; only at the end of the process, after the comment period had closed, did the FDA switch its position and insert the contrary position into the preamble of the final rule. The process failure bespeaks lack of engaged debate on the matter and certainly raises the bar with respect to the kind of evidence the FDA would have to provide to substantiate preemption. While the preamble seems a fairly egregious process failure, more generally, agencies are notorious for flouting the congressional and executive commands that they conduct federalism impact statements and carefully assess any alleged conflict between their regulations and state tort law. I have previously suggested that courts should condition deference to agencies’ regulations on their undertaking these basic responsibilities.
In terms of accountability, it is heartening that the FDA is proceeding with revisions to the CBE regulation via public notice-and-comment rulemaking—albeit against the backdrop of the Wyeth litigation—and not replicating the mistakes of the procedurally flawed process that led to promulgation of the preemption preamble.
But the FDA is still trying to accomplish too much at the wholesale level by “legal interpretation” and too little at the retail level by way of “regulatory record.” Applying the framework I have set out above to the Wyeth case, the agency’s regulatory record should have to supply direct, hard evidence on the precise risks considered by the FDA and provide some record evidence to substantiate the danger of overwarning.
Wyeth argues that the FDA did in fact conduct a cost-benefit analysis with regard to the precise risk at issue, but provides little in the way of record evidence to substantiate this claim. The Solicitor General more circumspectly argues that the FDA was “fully aware” of the precise risk. Some ground exists between the SG’s position that awareness of the risk suffices and the plaintiff-respondent’s position that nothing short of the FDA’s specific rejection of the warning proposed by plaintiff will do. The difference between awareness of a risk and conducting a thorough risk-risk analysis in approving the drug label without requiring further warnings is really a matter of the FDA’s supplying the requisite record evidence to show that it thoroughly considered the issue.
A key problem in this case, however, is that the Vermont Supreme Court gave short shrift to the agency and its actions, so there is an incomplete regulatory record before the U.S. Supreme Court. And plaintiff’s counsel certainly seemed to have free rein to denigrate the FDA’s role, exhorting the jury to take on the FDA’s role: “Thank God we don’t rely on the FDA to rely on this drug and make the safe decision. You will make the decision.”
The Vermont Supreme Court did not solicit the views of the FDA (nor did the FDA intervene in the case on its own). The agency record evidence before the Court consists of letters between Wyeth and the FDA concerning the labeling of the anti-nausea drug Phenergan over a span of nearly fifty years. The letters establish that FDA was made aware of the risk posed by inadvertent intra-arterial injection of Phenergan. What is missing are the FDA’s reasoned explanations of its action in approving the label, notwithstanding its understanding of the relevant risks, for example, because they are outweighed by greater risks inherent in overwarning.
With respect to the danger of overwarning, the FDA continues its practice (also evident in the preemption preamble) of speaking in broad generalities. The FDA is thus vulnerable to criticisms that it has supplied “abstract concerns and dire predictions” as opposed to hard “evidence of interference.” Some of the Wyeth amici have tried to come to the FDA’s aid by supplying concrete examples of overwarning. But, of course, this cannot fill the void with respect to the FDA’s particular consideration of the inherent risks in the case at hand. Moreover, with its proposed CBE regulation, the FDA makes a wholesale pitch for deference based upon its general overwarning argument. In a comment to the proposed rule, Senator Kennedy (along with six colleagues) asked point blank for the FDA to substantiate its overwarning claim. In response to his query asking the FDA to provide specific examples where a manufacturer had used the CBE procedure to add a warning that had proved detrimental to public health, the FDA provided a mere four examples—three of which were examples where the FDA had in fact required a stronger warning, and the remaining one involved a label that was approved after the manufacturer submitted some additional data.
Perhaps the wisest course for the U.S. Supreme Court, then, would be to reverse and remand Wyeth, directing the Vermont Supreme Court to put into practice something akin to the “agency reference model” with searching judicial review. Such a framework would, as an initial matter, require the court to solicit input from the FDA and to accord deference to FDA findings of implied conflict to the extent that they are supported by substantial evidence in the agency record.
To be sure, judicial scrutiny of the agency record is potentially burdensome. The Solicitor General raises the specter of intrusive, second-guessing of the agency’s decisionmaking via costly litigation. But there are also corresponding long-term gains, not only in terms of ensuring that the agency has actually carefully considered the risks at issue, but also in terms of fueling more comprehensive and transparent agency decisionmaking.
We began the preemption inquiry in Riegel with the text of the statute, which is where Justice Scalia’s majority opinion claims we may also end. But in cases where Congress has either not been clear or (quite commonly) has sent contradictory signals in the statutory language, courts must go further down an implied conflict preemption path. This is just what the Riegel majority did, even while disclaiming the need to look beyond the text. Where are courts to turn next? We made a brief stopover to consider the presumption against preemption statutory canon of construction; but we did not stay long. Nowhere in the Riegel majority is this once-esteemed canon mentioned; if anything, Riegel signals its potential demise, or at least its waning influence over the Justices. We moved on to consider policy preferences. As a positive matter, it is difficult not to characterize some portions of the Court’s opinion—both the embrace of the regulatory role of state tort law and, further, the perception of the jury as ill-equipped to handle cost-benefit decisionmaking—as reflecting policy preferences. But this raises troubling normative implications. The Justices’ anxiety here manifests itself in the Court’s repeated efforts to ascribe such policy choices to Congress. But the evidence mustered—the text of the statute—is in fact rather oblique on these points.
So we come finally to a more comfortable resting place, and consider the role of federal agencies in assisting courts with their preemption decisionmaking and the concomitant level of judicial scrutiny over agency findings. The Justices’ queries during oral argument in Riegel—with Wyeth looming in the distance—point in the direction of a new framework for implied conflict preemption decisions: The key is discerning whether the FDA has weighed in on the precise risk that the state tort action likewise seeks to regulate. Questions of implied conflict preemption—whether or not state common law actions are irreconcilable with, or would stand as an obstacle to, frustrate or impede, the command of federal regulatory directives and goals—should turn, first and foremost, upon a particularized understanding of the regulatory review and action taken by the relevant agency. Input from the relevant agency constitutes one pillar of the framework; the second is searching judicial review of the record evidence amassed by the agency in support of any preemptive position.
To whom much is given, much is required. Under the proposed agency reference model, the FDA would be given an enhanced role, partnering so to speak with the courts in making preemption determinations; for this reason, courts must ensure that the actions and positions taken by the FDA merit deference. Redirecting the preemption inquiry in these directions would go a long way towards helping courts make implied conflict preemption decisions in products liability cases, where statutory text provides scant guidance.
46. Riegel, 128 S. Ct. at 1009 (citation omitted); see also id. at 1015-16 & n.18 (noting that the FDA had reversed its “long held view” against preemption and that the “FDA’s new position is entitled to little weight”) (Ginsburg, J., dissenting).
48. Id. See Kristen E. Hickman & Matthew D. Kreuger, In Search of the Modern Skidmore Standard, 107 Colum. L. Rev. 1235, 1281–91 (2007) (demonstrating, based upon a review of more than one hundred recent federal appellate cases applying Skidmore deference, that courts tend to apply Skidmore as a sliding scale based upon five key factors: (1) the thoroughness of the agency’s consideration, (2) the formality of the agency’s procedure in staking out its interpretation, (3) the validity of the agency’s reasoning, (4) the consistency of the agency’s interpretations, and (5) the relevance of agency expertise) (link).
49. Brief for the United States as Amicus Curiae Supporting Respondents/Cross Petitioners at 20, Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) (Nos. 95-754, 95-886), 1996 WL 118035, at *20.
50. Brief for the United States as Amicus Curiae at 13, Smith Indus. Med. Sys., Inc. v. Kernats, 522 U.S. 1044 (1997) (No. 96-1405), 1997 WL 33561767, at *13.
51. 376 F.3d 163 (3d Cir. 2004).
52. Letter-Brief for the United States as Amicus Curiae at 16–17, Horn v. Thoratec, 376 F.3d 163 (3d Cir. 2004) (No. 02-4597), 2004 WL 1143720, at *16–17 [hereinafter Horn Letter-Brief for the United States as Amicus Curiae].
53. See, e.g., Epstein, supra note 37, at 15 (“[A]ny court wedded to Chevron deference has to abide by [agency decisions regarding preemption] . . . . so that the preemption question could oscillate to and fro with a change in personnel and administrations.”).
54. Riegel Oral Argument, supra note 15, at 39.
56. Riegel v. Medtronic, Inc., 451 F.3d 104, 125 (2d Cir. 2006) (citing Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 42 (1983)).
57. Horn Letter-Brief for the United States as Amicus Curiae, supra note 52, at 3.
58. Brief for the United States as Amicus Curiae, On Petition for Writ of Certiorari, at 17, Riegel v. Medtronic, 128 S. Ct. 999 (2008) (No. 06-179), 2007 WL 1511526. The SG expanded upon this rationale only a tad in its amicus brief at the merits stage: “[T]he United States’ earlier position was based in part on proposed regulations that FDA has since withdrawn, and its prior position is inconsistent with FDA’s current understanding and application of the risk-management principles discussed above (e.g., the need to prevent over-warning). Neither FDA’s reasoned change in position, nor the absence of a formal agency regulation addressing the specific question presented here, negates deference.” Brief for the United States as Amicus Curiae Supporting Respondent at 24, Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008) 2007 WL 3231418, at *24 [hereinafter Riegel Brief for the United States as Amicus Curiae] (citing Auer v. Robbins, 519 U.S. 452, 461–62 (1997)).
59. Brian Galle and Mark Seidenfeld have likewise called for something akin to Skidmore deference, coupled with a type of “hard look” review, which would allow agencies the flexibility to change their position when necessary, offering agencies incentive to show that they reached their decision through “good and open deliberation.” Brian D. Galle & Mark Seidenfeld, Administrative Law’s Federalism: Preemption, Delegation, and Agencies at the Edge of Federal Power, 57 Duke L.J. (forthcoming 2008), available at http://ssrn.com/abstract=1101141. See also Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 42–43 (1983) (“[A]n agency changing its course by rescinding a rule is obligated to provide a reasoned analysis for the change . . . . [T]he agency must examine the relevant data and articulate a satisfactory explanation for its action.”). I have in mind something like “State Farm with teeth,” keeping in mind that the Second Circuit gave the green light to the FDA’s changed position pursuant to what I would characterize as a “lax State Farm” standard, see supra notes 56–57 and accompanying text.
60. Riegel Oral Argument, supra note 15, at 31–32 (“If you look at the file of a PMA proceeding after it is concluded, can you tell exactly which design features and which risks the FDA has considered?”).
61. In response to Justice Alito’s question, Wyeth’s attorney answered: “No, I don’t think you can . . . . The FDA will have examined, and presumably done its job, with respect to every aspect of the design, manufacture, and labeling of the device. . . .” Id. at 32 (Mr. Olson). The government likewise resisted the suggestion:
We don’t think that a preemption test can really realistically turn on that. That would require extensive and intrusive inquiry into what FDA had done. We think that the best way to look at this is what the end product was . . . . You look at what was put before the agency and what was approved, not what might have gone into—into consideration.
Id. at 50 (Mr. Kneedler).
62. In the wake of Riegel, some news media headlines pronounced the death of claims by those injured by medical devices. See, e.g., Robert Barnes, Supreme Court Shields Medical Device Makers; Decision Rules Out State Lawsuits Over Products That Meet FDA’s Highest Standards, Wash. Post, Feb. 21, 2008, at D1, available at http://www.washingtonpost.com/wp-dyn/content/article/2008/02/20/AR2008022001140.html (“Yesterday’s decision seemed in step with the court’s recent rulings favoring business and expressing skepticism about the role of civil lawsuits in disciplining corporations.”) (link); Janet McConnaughey, A ‘Get Out of Jail Free Card’ for Manufacturers; If Regulatory Agency OK’d Product, Jury Can’t Second Guess, Pittsburgh Post-Gazette, Mar. 31, 2008, at A4; see also Editorial, No Recourse for the Injured, NY Times, Mar. 22, 2008, at 22, available at http://www.nytimes.com/2008/02/22/opinion/22fri1.html?_r=1&oref=slogin (reading Riegel to “mean that any consumer harmed by a fault device . . . will have no chance of fair compensation and the manufacturer will have a dangerous sense of impunity”) (link).
63. See Riegel v. Medtronic, Inc., 128 S. Ct. 999, 1006 (2008). Not surprisingly, a proliferation of such claims is anticipated. Drug and Device Law Blog, http://druganddevicelaw.blogspot.com/search?q=July+17%2C+2008 (July 17, 2008, 12:27 EST) (“Watch out for disguised ‘manufacturing’ claims. . . . We’ll need to watch carefully for plaintiffs trying to pass off what are really Riegel-preempted design defect claims . . . as so-called ‘manufacturing’ claims.”) (link).
64. Riegel, 128 S. Ct. at 1011.
65. See id. at 1013 n.1 (Ginsburg, J., dissenting) (“The Court’s holding does not reach an important issue outside the bounds of this case: . . . where evidence of a medical device’s defect comes to light only after the device receives premarket approval.”). The majority opinion is silent here—although several of the Justices took an interest in this issue during oral argument, see Riegel Oral Argument, supra note 15, at 26–27 (Roberts, C.J.); id. at 27–28 (Kennedy, J.); id. at 28 (Stevens, J.); id. at 29 (Souter, J.)—so perhaps the most that can be said is that this is an open (and sure to be heavily litigated) issue. The approach I have advocated—with due attention to the agency’s regulatory record as to the precise risk regulated—is consistent with Justice Ginsburg’s position here.
66. See Riegel, 128 S. Ct. at 1018–19 & n.16 (Ginsburg, J., dissenting).
67. Riegel Oral Argument, supra note 15, at 11. Justice Scalia’s view of Riegel seemed to go the farthest, pushing beyond implied conflict preemption to the broader realm of implied field preemption. Id. at 12 (“It is field preemption, isn’t it?”). This more expansive view was taken up by the government, arguing as amicus curiae in support of the respondent device manufacturer. See id. at 42 (“[M]aybe in this context it is best to conceptualize it as field preemption, of the things that are included within the application that is submitted to the FDA and the labeling.”).
69. See Posting of Ted Frank to PointofLaw.com, http://www.pointoflaw.com/archives/2008/02/riegel-v-medtronic.php (Feb. 20, 2008, 24:38 EST) (calling Riegel “[a] phenomenally good . . . decision [that] . . . bodes well for the cause of federal preemption in the pending [Kent] and [Wyeth] cases”) (link); Drug and Device Law Blog (Feb. 20, 2008), http://druganddevicelaw.blogspot.com/2008/02/more-on-riegel.html (Feb. 20, 2008, 08:13 EST) (“[W]e have to say that we feel better about [Wyeth] after reading [Riegel].”) (link); see also Posting of Amanda to Poptort.com (Feb. 21, 2008), http://www.thepoptort.com/2008/02/in-love-us-supr.html (Feb. 21, 2008, 11:46 EST) (lamenting that Riegel “was clearly a Valentine gift (a few days belated) to drug companies—and there’s more to come!”) (link).
In a telling exchange during the Kent oral argument, Justice Breyer certainly telegraphed his leanings as well. See Transcript of Oral Argument at 30, Warner-Lambert Co., 128 S. Ct. 1168 (No. 06-1498) (“Now, who would you rather have make the decision as to whether this drug is, on balance, going to save people or, on balance, going to hurt people? An expert agency, on the one hand, or 12 people pulled randomly for a jury role who see before them only the people whom the drug hurt and don’t see those who need the drug to cure them?”).
70. Riegel, 128 S. Ct. at 1009.
71. Id. (“[I]f . . . Congress wanted the two regimes [medical devices and drugs] to be alike; Congress could have applied the pre-emption clause to the entire FDCA. It did not do so, but instead wrote a pre-emption clause that applies only to medical devices.”).
72. Not only are the FDCA drug provisions bereft of any preemption provision, but they also contain a qualified savings clause: “Nothing in the amendments . . . shall be construed as invalidating any provision of State law which would be valid in the absence of such amendments unless there is a direct and positive conflict between such amendments and such provision of State law.” Drug Amendments of 1962, § 202, 76 Stat. 780, 793 (1962) (codified as 21 U.S.C. § 321 (2007)) (link); see also Sharkey, Products Liability Preemption, supra note 11, at 503–04 (arguing that “direct and positive conflict” language embraces implied conflict preemption of both the impossibility and obstacle/frustration of purposes varieties).
73. 128 S. Ct. 1168 (2008) (mem). This “non-decision” let stand the Second Circuit opinion below, which held that common law tort claims were not impliedly preempted in a case applying a statutory fraud exception to a drug liability immunity provision. Id. For a discussion of the wider implications of the issues raised in Kent, see Catherine M. Sharkey, The Fraud Caveat to Agency Preemption, 102 Nw. U. L. Rev. 841 (2008) [hereinafter Sharkey, The Fraud Caveat to Agency Preemption].
74. Riegel, 128 S. Ct. at 1018 (Ginsburg, J., dissenting); see also Riegel Oral Argument, supra note 15, at 25 (Ginsburg, J.) (“I would think that if everything that [counsel for device manufacturer] said about new devices would apply in bold letters to new drugs, because the testing procedures are much longer, are they not?”).
75. See Riegel, 128 S. Ct. at 1018–19 n.15 (Ginsburg, J., dissenting) (citations omitted) (recounting the details of the FDA’s process for approving a new drug).
76. Riegel Brief for the United States as Amicus Curiae, supra note 58, at 11; see also Brief of the United States as Amicus Curiae Supporting Petitioner at 13–15, Wyeth v. Levine, 128 S. Ct. 1118 (2008) (No. 06-1249), 2008 WL 2308908, at *13–15 [hereinafter Wyeth Brief of the United States as Amicus Curiae Supporting Petitioner] (“FDA’s ‘rigorous evaluation process’ . . . scrutinizes everything about the drug—from the design of clinical trials to the severity of side effects to the conditions under which the drug is manufactured. [A]n FDA review team—medical doctors, chemists, statisticians, microbiologists, pharmacologists, and other experts—evaluates whether the studies the sponsor submitted show that the drug is safe and effective for its proper use.’”) (alterations in original) (quoting FDA, The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective (Review Process) (visited June 2, 2008), http://www.fda.gov/fdac/special/testtubetopatient/drugreview.html).
77. Levine v. Wyeth, 944 A.2d 179, 197 (Vt. 2006) (Reiber, C.J., dissenting).
78. The CBE regulation permits a drug manufacturer which has filed a supplemental new drug application to the FDA to implement a labeling change before the FDA has acted on the application either “[t]o add or strengthen a contraindication, warning, precaution, or adverse reaction” or “[t]o add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product.” 21 C.F.R. § 314.70(c)(6)(iii)(A),(C) (2007).
79. Labeling and Prescription Drug Advertising, 44 Fed. Reg. 37,434, 37,447 (June 26, 1979).
80. Brief for Petitioner at 10, Wyeth v. Levine, 128 S. Ct. 1118 (2008) (No. 06-1249), 2008 WL 2273067 [hereinafter Wyeth Brief for Petitioner]. According to Wyeth, “[t]hat reading is supported by the history of the regulation and its relationship to the purposes of the FDCA as a whole; it is also the interpretation that FDA has reasonably advanced.” Id. at 27.
81. In addition, “as a practical matter, FDA encourages sponsors to consult with FDA prior to adding safety-related information to the labeling for an approved product even when such a change is submitted in a CBE supplement, and sponsors typically do so.” Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices, 73 Fed. Reg. 2848, 2849 (proposed Jan. 16, 2008) (to be codified at 21 C.F.R. pts. 314, 601, 814).
82. Id. at 2849.
83. Id. (explaining that unilateral decisions by the manufacturer “would disrupt FDA’s careful balancing of how the risks and benefits of the product should be communicated”).
84. Id. at 2850 (defining “newly acquired information” on safety as “data, analyses, or other information not previously submitted to the agency, or submitted within a reasonable time period prior to the CBE supplement, that provides novel information about the product, such as a risk that is different in type or severity than previously known risks about the product”).
85. See Wyeth Brief of the United States as Amicus Curiae Supporting Petitioner, supra note 76, at 22 (arguing that a manufacturer can unilaterally change a drug label only “to correct concerns about newly discovered risks from use of the drug”) (quoting 47 Fed. Reg. 46,622, 46,623 (Oct. 19, 1982)) (emphasis added in original)); see also id. at 15 (noting that manufacturers typically consult with the FDA before making any changes to the drug’s labeling).
86. Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 71 Fed. Reg. 3922, 3934 (Jan. 24, 2006).
89. Here, I put to one side the arguably separate and important interest in uniformity. Brief for the United States as Amicus Curiae at 5, In re Paxil Litig., No. CV 01-07937 MRP, 2002 WL 31375497, at *5 (C.D. Cal. Sept. 5, 2002) (“[T]he public undoubtedly would receive inconsistent information from region to region.”).
90. 71 Fed. Reg. at 3935.
91. 73 Fed. Reg. at 2851
92. Id.; see also 71 Fed. Reg. at 3935.
93. Brief of the United States as Amicus Curiae in Support of Defendants-Appellees at 16, Colacicco v. Apotex Inc., 521 F.3d 253 (3d Cir. 2008) (No. 06-3107), 2006 WL 5691532, at *16.
94. Sharkey, Preemption by Preamble, supra note 23, at 254 (noting that the FDA’s decision to insert preemptive language in the preamble “provoked charges that it had flouted its obligation to consult with State and local authorities and circumvented the proper notice-and-comment process”).
95. Id. at 256–57 (“Consistent with Executive Order 13,132, courts might condition deference to agency interpretations of the preemptive scope of regulations on compliance with various congressional and executive measures designed to increase the public participation of states, the legislature, and outside political groups: consultation mandates, ‘federalism impact statements,’ or even notice-and-comment periods could be required for all preemption statements.”).
96. See 73 Fed. Reg. at 2850 (“FDA invites comments regarding the circumstances when information regarding a safety issue associated with a drug . . . should be considered newly acquired and thus appropriate to be included in a CBE supplement.”); see also id. at 2853 (“FDA invites comments from State and local officials.”).
97. Wyeth Brief for Petitioner, supra note 80, at 28 (referring to FDA’s “determination that, with appropriate warnings and instructions . . . the benefits of IV administration . . . outweigh the well-known risk of harm”).
98. Wyeth Brief of the United States as Amicus Curiae Supporting Petitioner, supra note 76, at 4 (“FDA was thus fully aware of the risk of an inadvertent intra-arterial injection, and the labeling or revised labeling it approved uniformly contained warnings to address that risk.”).
99. Here, I agree with the Solicitor General that “[t]he agency could not reasonably be expected to expressly reject every possible variant of approved labeling as part of its decisional process.” Id. at 25.
100. I have criticized the Vermont Supreme Court’s Wyeth decision as an example of the “presumption against preemption” run amok. Sharkey, Products Liability Preemption, supra note 11, at 507 (“In the hands of the [Wyeth] Court, the presumption does most of the necessary work to resolve the case. It is as if the presumption casts a wide protective shadow against implied preemption; regardless of the precise risk regulated by the FDA or specific agency actions taken, the FDA is taken to impose minimum safety standards, ripe for supplementation by state tort law.”).
101. Joint Appendix at 211, Wyeth v. Levine, 128 S. Ct. 1118 (2008) (No. 06-1249), 2008 WL 2309484 [hereinafter Wyeth Joint Appendix].
102. See id. at 266–385 (letters between the FDA and Wyeth).
103. My read of the scant agency record is that the evidence implies that FDA was not only aware of, but had actively considered, the competing risks. The Vermont Supreme Court, by contrast, was convinced that “[t]he FDA could have rejected the new warning for any number of reasons, including clarity or technical accuracy, without implicitly prohibiting a stronger warning.” Levine v. Wyeth, 944 A.2d 179, 189 (Vt. 2006). Disputed inferences, however, should not lie at the heart of a sound implied conflict preemption analysis. My approach seeks to put the analysis on sounder evidentiary footing.
104. Regulatory Preemption: Are Federal Agencies Usurping Congressional and State Authority?: Hearing Before the S. Comm. on the Judiciary 110th Cong. (1997) (statement of David C. Vladeck, Professor of Law, Georgetown University Law Center), available at http://www.law.georgetown.edu/oneillinstitute/documents/vladeck_testimony.pdf (last visited July 2, 2008) (link).
105. Brief of Washington Legal Foundation & American College of Emergency Physicians as Amici Curiae in Support of Petitioner at 13–26, Wyeth v. Levine, 128 S. Ct. 1118 (No. 06-1249) (June 3, 2008), 2008 WL 2355771, at *13–26 (describing recent scientific and medical studies demonstrating adverse public health consequences of overwarning); Brief of John E. Calfee et al. at 11, Wyeth, 128 S. Ct. 1118 (No. 06-1294) (June 3, 2008), 2008 WL 2322237, at *11 (discussing risks of overwarning and “‘clutter’: the presence of so much information that physicians would find it hard to distinguish important information from relatively unimportant information and might not even bother to peruse all the information”).
106. Letter from Stephen R. Mason, Acting Assistant Commissioner for Legislation, FDA to The Honorable Edward M. Kennedy, Chairman, Committee on Health, Education, Labor, and Pensions 3 (Mar. 7, 2008), available at http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=FDA-2008-N-0032 (follow the “Page 2” link at the bottom of the page, then follow the “FDA-2008-N-0032-0023.4”) (link).
107. See, e.g., Ronald J. Krotoszynski, Jr., “History Belongs to the Winners”: The Bazelon-Leventhal Debate and the Continuing Relevance of the Process/Substance Dichotomy in Judicial Review of Agency Action, 58 Admin. L. Rev. 995, 1002 (2006) (discussing various challenges facing “hard look review” of the substance of agency decisionmaking).
108. Wyeth Brief of the United States as Amicus Curiae Supporting Petitioner, supra note 76 (“With the passage of time, however, it would be increasingly difficult to reconstruct the agency’s decisionmaking process . . . preemption analysis would devolve into an intrusive, and potentially inconclusive, second-guessing of the agency’s decisional process.”).
109. If the agency regulatory record before the Court is incomplete in Wyeth, where there was a fifty-year history of correspondence between the manufacturer and the FDA over various risks, imagine the dearth of record evidence that might emerge in other cases. Moreover, without a developed agency record courts will have great difficulty in determining whether evidence of new risks has come to light since FDA approval. The plaintiff in Wyeth apparently did not make any such allegation. See Brief for Petitioner at 27, Wyeth v. Levine, 128 S. Ct. 1118 (2008) ( No. 06-1249), 2008 WL 2273067, at *27 (“[R]espondent has never suggested that Wyeth had any new information about the risks of IV administration of Phenergan that would have warranted a change without FDA approval.”) (Amended Complaint); Wyeth Joint Appendix, supra note 101, at 16 (alleging that Wyeth had “known for more than 25 years of the grave risks associated with inadvertent arterial injection or extravasation of Phenergan, including irreversible gangrene and amputation”). But, again, this is likely to be a highly controversial issue in future cases down the road and one that should not be left to inferences drawn from partial agency records.
110. See, e.g., Mark Seidenfeld, Cognitive Loafing, Social Conformity and Judicial Review of Agency Rulemaking, 87 Cornell L. Rev. 486, 523–26 (2002) (discussing the beneficial effects that the knowledge of impending judicial review of an agency record can have of the quality of agency decisionmaking processes) (link); Mark Seidenfeld, The Psychology of Accountability and Political Review of Agency Rules, 51 Duke L.J. 1059, 1064 (2002) (arguing that “hard look” judicial review encourages an increased sense of accountability in agencies, leading them to “take greater care and avoid [decisionmaking] biases,” and to engage in information seeking behavior).
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