The fraud caveat to agency preemption

Northwestern University Law Review

Volumn 102, Issue 2, 2008, Pages 841-867

  Sharkey, Catherine M ^a  

^a NEW YORK UNIVERSITY SCHOOL OF LAW   (United States)

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EID: 47849094524     PISSN: 00293571     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (117)

1. For a discussion of recent efforts by federal agencies to wield preemptive authority, see Catherine M. Sharkey, Preemption by Preamble: Federal Agencies and the Federalization of Tort Law, 56 DEPAUL L. REV. 227, 229-42 (2007).
2. See, e.g., Nina A. Mendelson, A Presumption Against Agency Preemption, 102 NW. U. L. REV. 695, 695 (2008) ("Federal agencies are increasingly taking aim at state law, even though state law is not expressly targeted by the statutes the agencies administer."); Margaret H. Clune, Stealth Tort Reform: How the Bush Administration 's Aggressive Use of the Preemption Doctrine Hurts Consumers 1 (Ctr. for Progressive Regulation, White Paper No. 403, 2004), available at http://www.progressiveregulation.org/ articles/preemption.pdf ("[A] much less visible aspect of these activities is the contribution [that FDA Chief Counsel David Troy's] substantive legal arguments are making to the Administration anticonsumer tort reform agenda.").
3. See, e.g., Richard A. Epstein, Why the FDA Must Preempt Tort Litigation: A Critique of Chevron Deference and a Response to Richard Nagareda, J. TORT L., Dec. 2006, at 23-25, http://www.bepress.com/ jtl/vol1/iss1/art5 ("What possible reason is there not to preempt litigation which on balance is worse than useless?").
4. Moreover, the canonical Products Liability Restatement-which endorses the jury's consideration of evidence of the defendant's regulatory compliance as part of its inquiry into whether a product is defective-accords "little or no weight" to such compliance where "the deliberative process that led to the safety standard with which the defendant's product complies was tainted by the supplying of false information to, or the withholding of necessary and valid information from, the agency that promulgated the standard or certified or approved the product." RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY § 4(b) cmt. e (1998).
5. Michigan alone has adopted a broad statutory regulatory compliance defense. Texas has adopted similar legislation that provides for a presumption that PDA-approved warnings on pharmaceutical products are adequate. Six additional states-Arizona, New Jersey, North Dakota, Ohio, Oregon, and Utah-bar punitive damages for PDA-approved drugs. See infra notes 36-38 and accompanying text. Nor is the "fraud caveat" exclusively the province of state legislation. When Congress enacted the National Childhood Vaccine Injury Compensation Act of 1986, it premised immunity from punitive damages on the absence of fraud. See 42 U.S.C. § 300aa-23(d)(2) (2000) ("[T]he manufacturer shall not be held liable for punitive damages unless the manufacturer engaged in-(A) fraud or intentional and wrongful withholding of information from the Secretary during any phase of a proceeding for approval of the vaccine . . . , (B) intentional and wrongful withholding of information relating to the safety or efficacy of the vaccine after its approval, or (C) other criminal or illegal activity relating to the safety and effectiveness of vaccines, which activity related to the vaccine-related injury or death for which the civil action was brought").
6. Ackermann v. Wyeth Pharms., 471 F. Supp. 2d 739, 749 (E.D. Tex. 2006), aff'd on other grounds, No. 06-41774, 2008 WL 1821379 (5th Cir. Apr. 24, 2008); see also Dusek v. Pfizer Inc., No. Civ.A. H-02-3559, 2004 WL 2191804, at *7 (S.D. Tex. Feb. 20, 2004) (rejecting plaintiffs allegation that "Pfizer did not provide the necessary cooperation and information to the agency," reasoning that "many of the instances of allegedly incomplete information given to the PDA are not persuasive"); Abramowitz v. Cephalon, Inc., 2006 WL 560639, at *3 (N.J. Super. Ct. Law Div. Mar. 3,2006) ("[T]he court finds that there is no evidence to suggest that the defendants attempted to hide or suppress [postmarketing risk] information.").
7. Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 71 Fed. Reg. 3922,3936 (Jan. 24,2006) (emphasis added).
8. In re Zyprexa Prods. Liab. Litig., 489 F. Supp. 2d 230, 240-41 (E.D.N.Y. 2007) (emphasis added).
9. Richard A. Nagareda, FDA Preemption: When Tort Law Meets the Administrative State, J. TORT L.,Dec. 2006, at 47, http://www.bepress.com/jtl/voll/issl/art4.
10. Id. at 46-47.
11. Here, Nagareda refused to weigh in. Id. at 46 ("I leave to others the broader question of whether statutory reform should embrace stand-alone actions for fraud on the FDA or whether, as the Buckman Court believed, they would disrupt the regulatory regime." (footnote omitted)).
12. 531 U.S. 341, 348 (2001) (holding that "plaintiffs state-law fraud-on-the-FDA claims conflict with, and are therefore impliedly pre-empted by, federal law" because the FDA was empowered by stat-ute to punish the fraud against it).
13. 128 S. Ct. 1168 (2008) (mem.).
14. In re Medtronic, Inc., Implantable Defibrillators Litig., 465 F. Supp. 2d 886, 899 (D. Minn. 2006).
15. Of late, institutional accounts of preemption seem to be gaining the upper hand over more conventional statutory interpretation approaches. See, e.g., Catherine M. Sharkey, Products Liability Preemption: An Institutional Approach, 76 GEO. WASH. L. REV. 449 (2008); see also Thomas W. Merrill, Preemption and Institutional Choice, 102 NW. U. L. REV. 727 (2008); Peter H. Schuck, Qualified Regulatory Preemption by the FDA: Finding the Sweet Spot, 13 ROGER WILLIAMS U. L. REV. (forthcoming 2008) (manuscript at 6-9, on file with the Northwestern University Law Review) (drawing upon Merrill's and Sharkey's accounts to argue that the "criterion of comparative institutional competence" should determine implied preemption questions including whether there has been fraud on the FDA).
16. Kent, 128 S. Ct. 1168.
17. The preemption question implicated here-whether state law is preempted to the extent that it requires a determination of fraud on the FDA-is separate and distinct from the much broader preemption inquiry regarding the extent to which the PDA's approval of a drug impliedly preempts state law claims. I take up this broader issue in Sharkey, supra note 15, at 502-20.
18. James T. O'Reilly, Losing Deference in FDA 's Second Century: Judicial Review Sharpens as Political Constraints Diminish a Legacy of Expertise, 93 CORNELL L. REV. (forthcoming 2008) (manuscript at 9, on file with the Northwestern University Law Review).
19. 531 U.S. 341, 344 (2001). Although the district court decision in the case held that the MDA's express preemption provision provided an additional source of preemption, id. at 347, the Supreme Court did not undertake an express preemption analysis. Id. at 348 n.2 ("[W]e express no view on whether these claims are subject to express preemption ...."). While Buckman itself addressed medical devices, it has been applied in the pharmaceutical context as well. See, e.g., Bouchard v. Am. Home Prods. Corp., 213 F. Supp. 2d 802, 812 (N.D. Ohio 2002) ("The Court does not need to engage in searching analysis of Buckman to determine that claims of fraud on the FDA are preempted with respect to pharmaceuticals." (citing Kemp v. Medtronic, Inc., 231 F.3d 216, 236 (6th Cir. 2000))); Flynn v. Am. Home Prods. Corp., 627 N.W.2d 342, 349 (Minn. Ct. App. 2001) ("Like the claims of fraudulent procurement of medical device approval at issue in Buckman, the existence of the federal regulations, is critical to appellant's claims that those regulations were violated and caused her injuries. Moreover, the Buckman Court's observation that 50 state law causes of action for violation of the PDA's detailed regulations would increase the burdens placed on applicants for FDA approval applies to drug manufacturers as well as to medical-device manufacturers."); Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961,965-66 (6th Cir. 2004) ("This case, however, presents a somewhat different legal regime from the one invalidated in Buckman.... This difference, however, is immaterial in light of Buckman."); Dusek v. Pfizer Inc., No. Civ.A. H-02-3559, 2004 WL 2191804, at *8 n.30 (S.D. Tex. Feb. 20, 2004) ("Although Buckman was a decision involving an orthopedic bone screws' manufacturer's application for an exception under § 501(k) for devices that were already on the market when the Medical Devices Amendments to the FDCA were enacted in 1976, the issues are comparable to those at bar.").
20. Plaintiffs claimed to have suffered injuries from implantation of orthopedic bone screws. The plaintiffs claimed that the FDA would not have approved the screws had the regulatory consultant for the manufacturer not made fraudulent representations regarding the screws' intended use. In other words, the claim of damages did not rest on the allegation of defective design or manufacture of the screws, but on their fraudulent approval and subsequent existence in the market. Buckman, 531 U.S. at 343.
21. Id. at 347-48 ("To the contrary, the relationship between a federal agency and the entity it regulates is inherently federal in character; the relationship originates from, is governed by, and terminates according to federal law."). For this reason, too, the presumption against preemption need not rear its head. Id. at 348.
22. 518 U.S. 470, 487-89 (1996) (explaining that Congress's intent in enacting the MDA was specific preemption of contradictory statutes, not broader general preemption). Lora Lohr was implanted with a Medtronic pacemaker that later failed. Lohr filed suit against Medtronic claiming that the medical device had been negligently manufactured, that Medtronic had failed to warn Lohr or her physicians of the risk of the device failing, and that the device had been defectively designed. Medtronic contended that all of Lohr's claims were expressly preempted by the MDA. Id. at 480-81.
23. Buckman, 531 U.S. at 352-53.
24. Id. at 350.
25. Id. The Court continued: "Would-be applicants may be discouraged from seeking ... approval of devices with potentially beneficial off-label uses for fear that such use might expose the manufacturer or its associates ... to unpredictable civil liability." Id. This precise concern regarding "off-label" uses for medical devices would not seem to pertain to pharmaceutical«. See, e.g., Kobar v. Novartis Corp., 378 F. Supp. 2d 1166, 1173 (D. Ariz. 2005) ("[T]he practice of off-label usage has no analog in the context of drug manufacturing."). Unlike drug manufacturers, which are precluded from discussing the risks associated with possible off-label uses, the FDA "encouragfes] the inclusion of information about the risks of off-label [device] use on the label itself." James M. Beck & Elizabeth D. Azari, FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions, 53 FOOD & DRUG L.J. 71, 89 (1998). According to the Pharmaceutical Research and Manufacturers of America, this duty to enumerate all foreseeable uses when requesting FDA approval means "[p]laintiffs . . . could (and likely would) allege, as here, that the manufacturer subjectively intended the device to be put to that use-either in lieu of, or in addition to, the listed 'intended use'-and defrauded the FDA by failing to disclose such intent." Brief of Amicus Curiae Pharmaceutical Research and Manufacturers of America in Support of Petitioner at 21-22, Buckman, 531 U.S. 341 (No. 98-1768), 2000 WL 1339143, at *21-22 (footnote omitted).
26. Buckman, 531 U.S. at 353.
27. Id. at 351.
28. See, e.g., Telbott v. C.R. Bard, Inc., 63 F.3d 25, 28 (1st Cir. 1995) ("We hold that Congress did not intend to provide an exception to the MDA's preemption clause where a manufacturer fails to comply with the provisions of the MDA by fraudulently obtaining approval of its device from the FDA."); id. at 29 ("Nothing in [the statutory express preemption clause] suggests that the state requirements are somehow revived by this failure to comply with the federal standard."). In Talbott, the FDA had previously initiated a criminal prosecution against the manufacturer of a medical device for conspiring to defraud the FDA. Id. ("The FDA has the broad power ... to initiate criminal prosecutions against manufacturers, as it did in this case against Bard."). The manufacturer pled guilty and paid civil and criminal fines. United States v. C.R. Bard, Inc., 848 F. Supp. 287,288-89 (D. Mass. 1994).
29. Brief for the United States as Amicus Curiae Supporting Petitioners at 23, Warner-Lambert Co. v. Kent, 128 S. Ct. 1168 (2008) (No. 06-1498), 2007 WL 4218889, at *23 [hereinafter Amicus Brief for the United States in Kent].
30. Id at 24.
31. See supra note 7 and accompanying text.
32. Buchnan, 531 U.S. at 353-54 (Stevens, J., concurring in the judgment).
33. See id, at 354 (noting that plaintiff's claims "would not depend upon speculation as to the PDA's behavior in a counterfactual situation").
34. Id. A recent case provides an apt illustration. According to the federal district court in Wawrzynek v. Statprobe, Inc., Civil Action No. 05-1342, 2007 WL 3146792 (E.D. Pa. Oct. 25, 2007), "this case essentially fits into the Buckman concurrence's exemption." Id. at *11. In that case, prior to the state court litigation, the FDA determined that the product manufacturer committed fraud during the regulatory approval process; indeed, the manufacturer entered a guilty plea based, in part, on its submission of false and misleading information to the FDA. Id. at *4. Although no formal action had been taken against the contract research organization working in tandem with the manufacturer, the court concluded that "[b]ecause the FDA found that fraud and wrongdoing occurred during the [medical device] approval process, the door to the Buckman concurrence was opened wide enough to allow both [the product manufacturer] and [the contract research organization] to pass through." Id. at *11 (emphasis omitted).
35. Compare Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961, 966 (6th Cir. 2004) ("[T]he [fraud] exemptions are invalid as applied in some settings (e.g., when a plaintiff asks a state court to find bribery or fraud on the FDA) but not in others (e.g. claims based on federal findings of bribery or fraud on the FDA)."), with Desiano v. Warner-Lambert & Co., 467 F.3d 85, 94-95 (2d Cir. 2006) (disagreeing with Garcia in holding that Buckman did not preempt traditional state law tort claims that triggered the statute's fraud exemption), aff'd per curiam by an equally divided Court sub nom. Warner-Lambert Co. v. Kent, 128 S. Ct. 1168 (2008) (mem.).
36. MICH. COMP. LAWS ANN. § 600.2946(5) (West 2007).
37. COLO. REV. STAT. § 13-21-403(1)(b) (2007); IND. CODE ANN. § 34-20-5-1(2) (West 1999); KAN. STAT. ANN. § 60-3304(a) (2005); KY. REV. STAT. ANN. § 411.310(2) (West 2005); N.J. STAT. ANN. § 2A:58C-4 (West 2000); TENN. CODE ANN. § 29-28-104 (2007); TEX. CIV. PRAC. & REM. CODE ANN. § 82.007(a) (Vernon 2005); UTAH CODE ANN. §78-15-6(3) (2005).
38. ARIZ. REV. STAT. ANN. § 12-701(a)(1) (2003); COLO. REV. STAT. § 13-64-302.5(5)(a) (2007); N.J. STAT. ANN. § 2A:58C-5(c) (West 2000); N.D. CENT. CODE § 32-03.2-11(6) (2007); OHIO REV. CODE ANN. § 2307.80(c)(1) (West 2006); OR. REV. STAT. § 30.927(1)(a) (2005); UTAH CODE ANN. §78-18-2(1) (2002).
39. 385 F.3d 961.
40. In Garcia, it was the plaintiff who claimed that the fraud exception was preempted and, thus, that the entire immunity statute should be nullified. Id. at 967 ("[T]he Plaintiff [urges the situation] where drug manufacturers would enjoy no immunity at all."). The court, however, determined that the fraud exception-which it held was partially void by preemption-could be severed from the remainder of the immunity statute. Id. ("[S]evering the preemption exemptions will not give license to drug manufacturers to use bribery or fraud as a means of obtaining FDA approval, then rely on that approval as a shield from products liability: it will merely place responsibility for prosecuting bribery or fraud on the FDA in the hands of the Federal Government rather than state courts."). Garcia's reasoning strongly suggests that the court would preempt failure-to-warn negligence per se claims based on allegations of fraud on the agency or failure to disclose risk information as required by the FDCA, unless the FDA has itself made such a determination. Id. at 966.
41. Id. at 966 (citing Garcia v. Wyeth-Ayerst Labs., 265 F. Supp. 2d 825 (E.D. Mich. 2003)).
42. Id. (citations omitted).
43. Though Garcia cites the Buckman majority, the position derives from Justice Stevens's concurrence, which is nowhere incorporated by the majority. Nor does Garcia explicitly weigh in on the relevance of the presumption against preemption-although the Desiano court did attempt to distinguish its reasoning on this basis. Desiano v. Warner-Lambert & Co., 467 F.3d 85, 94 n.6 (2d Cir. 2006) ("[T]he Sixth Circuit's holding in Garcia was based on the assumption that no presumption against preemption applied."), off d per curiam by an equally divided Court sub nom. Warner-Lambert Co. v. Kent, 128 S. Ct. 1168(2008).
44. Federal district courts in Michigan have had occasion to apply Garcia's holding. See, e.g., Zammit v. Shire U.S., Inc., 415 F. Supp. 2d 760, 768 (E.D. Mich. 2006) ("[T]he Court finds that this proposed avenue of proof is foreclosed by ... Garcia [because] . . . plaintiff has neither alleged nor produced any evidence that the FDA itself has found any fault with Defendant's conduct or submissions during the course of the company's applications for agency approval. . . ."); Ammend v. Bioport, Inc., Nos. 5:03-CV-31, 1:03-CV-254, 1:03-CV-809, 1:05-CV-182, 2006 WL 1050509, at *3-4 (W.D. Mich. Apr. 19, 2006) (applying Garcia retroactively to support summary judgment of plaintiffs claim for fraud in the approval of an anthrax vaccine). Michigan state courts have also affirmed this interpretation. See, e.g., Duronio v. Merck & Co., No. 267003, 2006 WL 1628516, at *5-6 (Mich. Ct. App. June 13, 2006) ("[W]e agree with [Garcia's] holding that the fraud-on-the[-]FDA exception is preempted by federal law unless the FDA itself determines that it was defrauded."). For courts outside Michigan interpreting Michigan law and invoking Garcia, see, for example, Henderson v. Merck & Co., No. 04-CV-05987-LDD, 2005 WL 2864752, at *1 (E.D. Pa. Oct. 31, 2005); Alli v. Eli Lilly & Co., 854 N.E.2d 372, 378-80 (Ind. Ct. App. 2006); Noms v. Pfizer Inc., 839 N.Y.S.2d 434, 2007 WL 969431, at »4 (N.Y. Sup. Ct. 2007) (unpublished table decision). Moreover, Garcia's reach extends further afield to other jurisdictions' laws. See, e.g., In re Aredia & Zometa Prods. Liab. Litig., No. 3:06-MD-1760, 2007 WL 649266, at *9 n.17 (M.D. Tenn. Feb. 27, 2007) ("[T]he FDA itself must make this finding of fraud."); Ledbetter v. Merck & Co., Nos. 2005-59499 & 2005-58543, 2007 WL 1181991, at *5 (Tex. Dist. Ct. Apr. 19, 2007) (preempting fraud exception to Texas immunity statute "to the extent that someone other than the FDA is being asked to make the determination"); cf. Kobar v. Novartis Corp., 378 F. Supp. 2d 1166, 1174-75 (D. Ariz. 2005) ("While the Court agrees with Garcia that no preemption need occur where the FDA has made a finding that it has been defrauded,... that is not the case here.").
45. Kobar, 378 F. Supp. 2d at 1173.
46. 467 F.3d 85.
47. Id. at 93-96. The federal district court below had, by contrast, followed the spirit of Garcia. Id. at 89. The district court, moreover, laid out a federalism-inflected argument for preventing courts from interfering with centralized, agency enforcement of federal standards: If plaintiffs covered by the Michigan statute were able to litigate claims of fraud on the FDA in individual personal injury suits, whether in state courts or in federal courts, the potential would exist for the FDA's personnel to be drawn into those controversies on a case-by-case basis over and over again. . . . [T]he exception in the Michigan statute is preempted, except where the plaintiff relies on a finding by the FDA, or in an action brought by the FDA, of material fraud in the new drug approval process absent which approval would not have been granted. Id.
48. Judge Calabresi argued that the immunity statute does not make common law claims conditional on a determination of fraud on the agency. Instead, according to Judge Calabresi, the statute creates an affirmative defense for drug manufacturers. Id. at 96 ("[T]He Michigan law in question does no more than create a defense that drug makers may invoke, if they so decide, and ... it is not up to the plaintiff to prove fraud as an element of his or her claim."). This creative interpretation, however, does not ad-dress the potential conflict whereby the court finds fraud where the FDA has not.
49. Id. at 95; see also id. ("Given Buckman's explanation of Medtronic [v. Lohr], Buckman cannot be read as precluding such preexisting common law liability based on other wrongs, even when such liability survives only because there was also evidence of fraud against the FDA.").
50. See supra notes 21-23 and accompanying text.
51. Desiano, 467 F.3d at 94. Judge Calabresi would require a clear signal from Congress to depart from the narrowest interpretation of Buckman: "Until and unless Congress states explicitly that it intends invalidation of state common law claims merely because issues of fraud may arise in the trial of such claims, we decline to read general statutes like the FDCA and the MDA as having that effect." id. at 96. In other words, the danger, according to Judge Calabresi, should preemption operate when fraud is merely used for its evidentiary significance, is that preemption would thereby swallow up the general presumption against preemption of state tort law causes of action absent clear-cut congressional specification.
52. Id. at 94n.6.
53. Ackermann v. Wyeth Pharms., 471 F. Supp. 2d 739, 749 (E.D. Tex. 2006) (echoing Desiano in holding that the Texas immunity statute "creates nothing more than a presumption which the Defendant is free to raise" and "does not create a cause of action where none existed before"), aff'd on other grounds, No. 06-41774, 2008 WL 1821379 (5th Cir. Apr. 24,2008).
54. Warner-Lambert Co. v. Kent, 128 S. Ct. 1168 (2008) (mem.). Although the circuit split is shallow (i.e., a 1-1 split between the Sixth and Second Circuits) and narrow (i.e., it implicates a disagreement regarding the interpretation of the Michigan immunity statute), presumably the Court was persuaded that important interests were at stake. See, e.g., Petition for a Writ of Certiorari at 11, Kent, 128 S. Ct. 1168 (No. 06-1498), 2007 WL 1420562, at *11 ("[T]he issues reach beyond the Michigan statute on which the Sixth and Second Circuit are in conflict. As part of tort reform efforts throughout the country, other states have enacted statutes limiting claims or damage recoveries for PDA-approved drugs unless the finder of fact determines under state law that there was fraud-on-the-FDA."); id. at 25 ("The conflict also will inject forum shopping considerations into the [multi-district litigation] process, which today handles much of the pharmaceutical product liability litigation."); Brief of the Product Liability Advisory Council as Amicus Curiae in Support of Petitioner at 14, Kent, 128 S. Ct. 1168 (No. 06-1498), 2007 WL 2126024, at *14 ("The pressing need for this Court's guidance stems not only from the cases where courts have already addressed the scope of Buckman, but also from thousands of other cases where the issue is pending or necessarily will arise.").
55. Epstein, supra note 3, at 13-14 ("[I]f [Judge Calabresi's] position is that fraud-on-the-FDA can be proved in order to rehabilitate the common law action, then the FDA will inevitably be enmeshed in state law litigation on the very matters that Buckman held were within the exclusive competence of the FDA.").
56. Nagareda, supra note 9, at 46-47; id. at 52 ("A world in which fraud on the agency threatens to blow up preemption from the industry's vantage point stands to be [a] world in which there will be less fraud itself.").
57. Desiano, 467 F.3d at 97 (emphasis omitted).
58. Geier v. Am. Honda Motor Co., 529 U.S. 861, 873 (2000) (alteration in original) (quoting Hines v. Davidowitz, 312 U.S. 52, 67 (1941)).
59. Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 352-53 (2001).
60. Id. at 353 (emphasis added).
61. Transcript of Oral Argument at 21, Buckman, 531 U.S. 341 (No. 98-1716), 2000 WL 1801621, at *21 (emphasis added).
62. See, e.g., Cupek v. Medtronic, Inc., 405 F.3d 421, 424 (6th Cir. 2005) ("Granting leave to amend on [the negligence per se count] would be futile because that count is a disguised fraud on the FDA claim.").
63. See Flynn v. Am. Home Prods. Corp., 627 N.W.2d 342, 348-49 (Minn. Ct. App. 2001) (citing 21 C.F.R. § 314.80-.81 (2000); 21 C.F.R. § 201.57 (2000)).
64. Id. at 349.
65. See supra notes 46-52 and accompanying text; see also Brown v. DePuy Spine, Inc., Nos. BRCV2006-00208,00209, 00211, 00630,2007 WL 1089337, at *12-13 (Mass. Super. Ct. Apr. 9, 2007) ("[T]here is no merit to [defendant's] argument that [Buckman] forecloses a claim predicated upon failure to disclose material information to the FDA in violation of the PDA regulations.").
66. In re Bextra & Celebrex Mktg. Sales Practices & Prod. Liab. Litig., No. M: 05-1699 CRB, 2006 WL 2374742, at *10 (N.D. Cal. Aug. 16, 2006).
67. Id.
68. Bouchard v. Am. Home Prods. Corp., 213 F. Supp. 2d 802, 812 (N.D. Ohio 2002).
69. Globetti v. Sandoz Pharm. Corp., No. CV98-TMP-2649-S, 2001 WL 419160, at *3 (N.D. Ala. Mar. 5, 2001); see also Brown, 2007 WL 1089337, at * 13 ("A state claim alleging negligence based on a failure to disclose known risks to the FDA and, thereafter, to patients is not impliedly preempted because liability does not exist solely by proof of a violation of FDA disclosure requirements.").
70. In re Medtronic, Inc., Implantable Defibrillators Litig., 465 F. Supp. 2d 886, 900 (D. Minn. 2006); see also In re Baycol Prods. Litig., 495 F. Supp. 2d 977, 1000 (D. Minn. 2007) ("[T]o the extent Dr. Kapit's testimony is offered only to show that the FDA was misled, or that information was intentionally concealed from the FDA, the testimony must be excluded. The Court will leave to the respective trial courts the admissibility determination of such testimony to the extent it is offered to support a claim that the medical community, treating physicians or patients were misled by Bayer's alleged failure to submit information to the FDA."); Eve v. Sandoz Pharm. Corp., No. IP 98-1429-C-Y/S, 2002 WL 181972, at *3 (S.D. Ind. Jan. 28, 2002) ("[E]vidence of [defendant's] interaction with the FDA may be pertinent to proving the [plaintiffs] claim, but it is not the basis for the claim itself.").
71. Warner-Lambert Co. v. Kent, 128 S. Ct. 1168 (2008) (mem.). During the Kent oral arguments, the Justices probed whether allowing a cause of action that included a fraud-on-the-FDA element would swamp the agency with discovery requests. Compare, e.g., Transcript of Oral Argument at 37-38, Kent, 128 S. Ct. 1168 (No. 06-1498), 2008 WL 495030, at *37-38 (Alito, J., questioning whether allowing state courts to make this inquiry would permit invasive and time-consuming examination of PDA's internal procedures), with, e.g., id. at *22, 27 (Stevens, J., expressing skepticism regarding the magnitude of the potential problem).
72. 128 S. Ct. 999, 1011 (2008) ("Although the [plaintiffs] now argue that their lawsuit raises parallel claims [they did not address the issue in earlier briefs]. We decline to address that argument in the first instance here.").
73. Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 353-54 (2001) (Stevens, J., concurring) ("This would be a different case if, prior to the instant litigation, the FDA had determined that petitioner had committed fraud.").
74. Id. at 354.
75. 544 U.S. 431,434-36 (2005).
76. 7 U.S.C. § 136v(b) (2000) (emphasis added).
77. Bates, 544 U.S. at 447.
78. Id. at 453.
79. Elsewhere, I develop what I term an "agency reference model" for judicial decisionmaking in the realm of products liability preemption. Sharkey, supra note 15, at 477-502.
80. As Lars Noah has pointed out, "[w]ith the proliferation of more or less detailed (and often ambiguous) regulatory requirements, gauging compliance may be difficult. . . . [E]fforts to determine whether a device manufacturer has complied fully with the requirements found in a premarket approval and any generally applicable regulations could present serious difficulties." Lars Noah, Reconceptualizing Federal Preemption of Tort Claims as the Government Standards Defense, 37 WM. & MARY L. REV. 903, 954 (1996). During the Kent oral arguments, several of the Justices acknowledged the potential sweep of the claim for privileging agency determinations of fraud in the Buckman context, which might logically extend to an agency's prerogative to determine whether a federal regulatory standard has been violated, or complied with, in the context of common law negligence per se claims and regulatory compliance defenses. See, e.g., Transcript of Oral Argument at 14, Warner-Lambert Co. v. Kent, 128 S. Ct. 1168 (2008) (No. 06-1498), 2008 WL 495030, at *14 (Scalia, J., questioning whether a jury should be allowed to determine whether the drug had complied with the FDA approval process); id. at * 17-19 (Souter, J., suggesting that the issue of FDA approval arises more generally in the contexts of offensive and defensive uses of compliance with federal regulations in state tort claims).
81. The FDA is subjected to one-sided institutional scrutiny here, given that the model I present above tips in favor of the agency's exclusive prerogative to determine fraud in this context. A true comparative institutional analysis would of course investigate the opposite side of the coin: How badly would the FDA drug approval process be skewed if state and federal courts took the lead in determining the sufficiency of information disclosure to the FDA, in light of concerns of public health and safety? It is difficult, however, to do much more than speculate given the dearth of state and federal court experience independently prosecuting fraud on the FDA through the tort system. Nonetheless, one might impugn as a general matter the competence of juries to make decisions in the FDA drug regulation context. See, e.g., Schuck, supra note 15, at 13-14 (arguing that juries are at a comparative disadvantage vis-à-vis the FDA with respect to "the ability to process detailed scientific research information and complex risk-risk tradeoffs, and to make or second-guess technocratic decisions about drug design and labeling").
82. Buckman describes in detail the federal enforcement mechanism created by the FDCA and MDA governing medical devices. Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 348-50 (2001). The FDA has similar enforcement powers with respect to regulating prescription drugs, though the na-ture of the statutory regime differs. Several scholars, nonetheless, contrast the PDA's ability to regulate medical devices with its ability to police prescription drugs. See, e.g., Michael D. Green & William B. Schultz, Tort Law Deference to FDA Regulation of Medical Devices, 88 GEO. L.J. 2119, 2145 (2000) ("[A] regulatory compliance defense for medical devices is even more undesirable [than one for PDA-approved drugs]."); Nagareda, supra note 9, at 53 ("For medical devices that have undergone full-scale premarket approval, the FDA gets its preemption stance right but its characterization of the underlying regulatory regime wrong. Preemption flows from a federal command in the nature of required forbearance from product change, even while the basic substantive standard for device approval sounds more in minimal, rather than optimal, regulation. For prescription drug labeling, by contrast, optimal regulation-here, the PDA's repeated assessments of the science on SSRIs-has produced a confused array of judicial conclusions about preemption.").
83. Buckman, 531 U.S. at 50 n.4 (quoting 21 U.S.C. § 337(a) as requiring '"[a]ll such proceedings for the enforcement, or to restrain violations, of this chapter [to] be by and in the name of the United States'").
84. 21 C.F.R. § 10.30 (2007); see also Eve v. Sandoz Pharm. Corp., No. IP 98-1429-C-Y/S, 2002 WL 181972, at *1 (S.D. Ind. Jan. 28,2002) ("[C]itizens may report wrongdoing to the FDA and petition the Agency to take action under 21 C.F.R. § 10.30.").
85. 21 C.F.R. § 10.30(e)(1) ("The Commissioner shall ... rule upon each petition filed . . . taking into consideration (i) available agency resources for the category of subject matter, (ii) the priority assigned to the petition considering both the category of subject matter involved and the overall work of the agency, and (iii) time requirements established by statute."). Response time is typically 180 days. Id. § 10.30(e)(2).
86. 21 U.S.C. § 372 (2000); 21 C.F.R. § 5.35 (2000).
87. See Buckman, 531 U.S. at 349 ("This flexibility is a critical component of the statutory and regulatory framework under which the FDA pursues difficult (and often competing) objectives.").
88. 21 U.S.C. § 332.
89. Id. § 333(g)(1) ("[A]ny person who violates a requirement of this Act which relates to devices shall be liable to the United States for a civil penalty in an amount not to exceed $15,000 for each such violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding."); id. § 333(f)(3)(A) (imposing civil monetary penalties for submission of false or misleading clinical trial information).
90. Id. § 333(a); see also Amicus Brief for the United States in Kent, supra note 29, at 24 n.7 ("When necessary and appropriate, the government has secured formal relief, including criminal convictions, against drug or device manufacturers who defrauded the agency."). This is in addition to the general criminal proscription on making false statements to the federal government, see 18 U.S.C. § 1001 (2000).
91. 21 U.S.C. § 334(a)(2)(D).
92. Id. § 334(a)(1).
93. Id. § 355(e) (providing for withdrawal of FDA approval where "the application contains any untrue statement of material fact"); id. § 331(jj)(3) (prohibiting the submission of false or misleading clinical trial information).
94. Id. § 352.
95. SPECIAL INVESTIGATIONS DIV., U.S. HOUSE OF REPRESENTATIVES, PRESCRIPTION FOR HARM: THE DECLINE IN FDA ENFORCEMENT ACTIVITY 8-9 (2006) [hereinafter PRESCRIPTION FOR HARM]. The only enforcement measure that increased significantly over this five-year period was the number of FDA-regulated products on the market that had to be recalled, which increased by forty-four percent. Id. at 9.
96. Settlements may also play a significant role, exacerbating the difficulty of gauging FDA enforcements. See, e.g., Amicus Brief for the United States in Kent, supra note 29, at 24 ("When FDA suspects fraud, it often reaches a settlement with the applicant in which the applicant pays a fine or takes corrective action (such as changes in labeling) without admitting liability.").
97. PRESCRIPTION FOR HARM, supra note 95, at 10.
98. See, e.g., Brief of the National Conference of State Legislatures et al., as Amicus Curiae Supporting Respondents at 24, Warner-Lambert Co. v. Kent, 128 S. Ct. 1168 (2008) (No. 06-1498), 2008 WL 194280, at *24 ('"FDA officials in Washington repeatedly reject[ed] the recommendations of career field officials urging enforcement actions, even in cases involving death and serious injury.'" (quoting PRESCRIPTION FOR HARM, supra note 95, at 6)).
99. INST. OF MED., THE FUTURE OF DRUG SAFETY: PROMOTING AND PROTECTING THE HEALTH OF THE PUBLIC 4-9 (2006); see also U.S. GOV'T ACCOUNTABILITY OFFICE, DRUG SAFETY: IMPROVEMENT NEEDED IN FDA'S POSTMARKET DECISION-MAKING AND OVERSIGHT PROCESS 27-29 (2006).
100. Michael D. Green, Statutory Compliance and Tort Liability: Examining the Strongest Case, 30 U. MICH. J.L. REFORM 461,495-96 (1997).
101. Id. at 476 (citing John K. Iglehart, The Food Drug Administration and Its Problems, 325 NEW ENG. J. MED. 217, 217 (1991)); see also ADVISORY COMM. ON FOOD & DRUG ADMIN., FINAL REPORT 11 (1991) ("It is glaringly apparent that the FDA cannot now execute all of its statutory responsibilities within the limitations of existing resources, a conclusion that is repeated throughout this report.").
102. Robert Rabin, Poking Holes in the Fabric of Tort: A Comment, 56 DEPAUL L. REV. 293, 301-02 (2007); see also David A. Kessler & David C. Vladeck, A Critical Examination of the FDA 's Efforts to Preempt Failure to Warn Claims, 96 GEO. L.J. 461, 466 (2008) ("The reality is that the FDA does not have the resources to perform the Herculean task of monitoring comprehensively the performance of every drug on the market. Recent regulatory failures have demonstrated the PDA's shortcomings in this regard.").
103. In re Zyprexa Prods. Liab. Litig., 489 F. Supp. 2d 230, 241 (E.D.N.Y. 2007).
104. Id. ("The PDA's attempts to keep abreast of and inform the public about dangerous side effects discovered only after a drug has been approved have been decried by many in the medical community as inadequate.").
105. Green, supra note 100, at 489 n.99.
106. Susan Okie, What Ails the FDA?, 352 NEW ENG. J. MED. 1063, 1066 (2005).
107. See, e.g., Ensuring Drug Safety: Where Do We Go From Here? Hearings Before the S. Comm. on Health, Educ., Labor & Pensions, 109th Cong. (2005); FDA 's Drug Approval Process: Up to the Challenge? Hearings Before the S. Comm. on Health, Educ., Labor & Pensions, 109th Cong. (2005); Hearings on Risk & Responsibility: The Roles of the FDA and Pharmaceutical Companies in Ensuring Safety of Approved Drugs, Like Vioxx, Before the H. Comm. on Gov't Reform, 109th Cong. 23, 55 (2005).
108. Food and Drug Administration Amendments Act of 2007, Pub. L. 110-85, 120 Stat. 823 (codified as amended in scattered sections of 21 U.S.C.).
109. See Peter Chang, Reauthorization of PDUFA: An Exercise in Post-Market Drug Safety Reform, 36 J.L. MED. & ETHICS 196, 198 (2008) (arguing that pursuant to the FDAAA "post-marketing surveillance programs should experience a sizeable transformation"); Kessler & Vladeck, supra note 102, at 467-68 ("[T]he Act provides the agency with new resources to monitor the safety of drugs on the market, it authorizes the agency to compel manufacturers to make labeling changes if negotiations with the manufacturers are unsuccessful, it provides the agency greater power to require manufacturers to undertake safety studies after drugs have been approved, and it promises to give the agency greater resources to monitor direct-to-consumer drug advertising." (footnotes omitted)). But see Peter Barton Hutt, The State of Science at the Food and Drug Administration, in FDA SCIENCE AND MISSION AT RISK: REPORT OF THE SUBCOMMITTEE ON SCIENCE AND TECHNOLOGY app. B, at B-5 (2007), available at http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_02_FDA%20Report% 20Appendices%20A-K.pdf (criticizing Congress for enacting "an unfunded FDA omnibus statute . . . that demands substantial FDA scientific resources to analyze and implement. . . with no plans for additional appropriated funds or personnel to implement it"); see also Margaret Gilhooley, Addressing Potential Drug Risks: The Limits of Testing, Risk Signals, Preemption, and the Drug Reform Legislation, 59 S.C. L. REV. 347, 350-51 (2008) ("The agency will now have express authority to require additional postmarket tests and new warnings, but the agency will have to issue regulations and guidance to establish the dispute resolution procedures needed to implement the authority, a process that could take years." (footnotes omitted)).
110. Preemption of state tort claims was a hotly contested issue during the House and Senate debates over the FDAAA. See Kimberly K. Egan & Alysson Russell Snow, Does the FDA Amendments Act of 2007 Preempt State Law? (DLA Piper Publ'ns, Oct. 10, 2007), http://www.dlapiper.com/global/ publications/Detail.aspx?ref=rv&pub=2696 (comparing the floor statement of Senator Tom Coburn (ROK) asserting that the '"newly expanded role of the FDA does and should preempt state law when it comes to drug safety and labeling,'" with the floor statement to the contrary by Senator Edward Kennedy (D-MA)-echoed by Senator Patrick Leahy (D-VT)-that '"Congress has stated very clearly in the legislation that we do not intend the new authority being given to FDA to preempt common law liability for a drug company's failure to warn its customers of health risks'"); see also Press Release, Maurice Hinchey, Statement Against FDA Amendments Act (July 11,2007), available at http://www.house.gov/ list/press/ny22_hinchey/morenews/ 071107FDAAmendmentsAct.html ("[T]Ws legislation does nothing to keep the FDA from its current, misinformed policy of preempting state law on drug policy.").
111. In re Zyprexa Prods. Liab. Litig., 489 F. Supp. 2d 230, 277 (E.D.N.Y. 2007) ("State law adequacy of warning claims may alert the FDA to potential inadequacies in product labeling. The current litigation against Lilly may be a testament to that fact." (citing Letter from FDA to Eli Lilly & Co. (Mar. 28, 2007))); see also Bates v. Dow Agrosciences LLC, 544 U.S. 431, 451 (2005) ("[L]abels will evolve over time, as manufacturers gain more information about their products' performance in diverse settings .... [T]ort suits can serve as a catalyst in this process."). This is one aspect of what Robert Rabin calls "the educational effect of tort." Rabin, supra note 102, at 302 ("Pretrial discovery has frequently unearthed both industry and regulatory agency practices that might otherwise never have seen the light of day."); see also Kessler & Vladeck, supra note 102, at 477 ("[T]he FDA has often acted in response to information that has come to light in state damages litigation....").
112. See, e.g., W. Kip Viscusi et al., Deterring Inefficient Pharmaceutical Litigation: An Economic Rationale for the FDA Regulatory Compliance Defense, 24 SETON HALL L. REV. 1437, 1454 (1994) ("[T]he [FDA] regulatory scheme already provides excessive deterrence of risks. This suggests that further regulation of pharmaceuticals through tort liability is inappropriate, except as a means to compel regulatory compliance with regulations requiring the sharing of adverse safety information.").
113. Id. at 1455 n.67; see also id. ("For this reason, litigation can play a useful role as an adjunct to ensure that the FDA receives truthful information.").
114. Id.
115. Central to the model I propose is the existence of an appropriate administrative process for citizen petitions, because an FDA finding of fraud is necessary to get the ball rolling (absent the FDA taking initiative on its own). The precise scope of the types of FDA "action" that private citizens may request pursuant to 21 C.F.R. § 10.30 is somewhat ambiguous. In Kent, the United States took the position that "[w]hile FDA takes suggestions of fraudulent representations very seriously, it does not have a process for considering allegations or making explicit findings of fraud in the abstract. Citizen petitions must seek specific types of administrative action, such as withdrawal of a drug's approval, not merely a finding of fraud." Amicus Brief for the United States in Kent, supra note 29, at 24. But the regulation itself would seem to give citizens wider berth. See 21 C.F.R. § 10.30(A)(3) (2007) ("If the petition requests the Commissioner to take or refrain from taking any other form of administrative action [apart from a request to issue, amend, or revoke a regulation or order], [the petition must describe] the specific action or relief requested." (emphasis added)). The United States, moreover, seems to have hardened its position since Buchnan, when it appeared to countenance a more liberal understanding of the scope of citizen petitions. Brief for the United States as Amicus Curiae Supporting Petitioner at 3-4, Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001) (No. 98-1768), 2000 WL 1364441, at *3-4 ("Any citizen who believes that a submitter has committed fraud may petition FDA to take administrative ac-tion."). The precise reforms to the administrative process-including the scope of judicial review of the agency's fraud findings-that may be required are beyond the scope of this Article.
116. There would, of course, be corresponding costs to this approach as well, including setting up an appropriate institutional framework for the FDA to handle such an influx of petitions. Indeed, as the United States ominously predicts: [I]f FDA were the gatekeeper for private tort liability, it could anticipate numerous petitions filed by prospective tort plaintiffs urging the agency to make a finding of fraud. The disposition of such petitions might prove every bit as burdensome for the agency as state-court litigation concerning whether FDA was defrauded. Amicus Brief for the United States in Kent, supra note 29, at 23. But see Brief for Respondents at 40-41 n.11, Warner-Lambert Co. v. Kent, 128 S. Ct. 1168 (2008) (No. 06-1498), 2008 WL 157174, at *40-41 n.11 ("[T]he United States does not offer any evidence of a deluge of citizen petitions-or any citizen petitions-filed since [Garcia] by Michigan patients requesting that the FDA make such findings.").
117. 117 As aptly put by a Virginia federal district court, a formal determination by the FDA of misconduct during the regulatory approval process "holds the gate open"; moreover, as the court emphasized, where a manufacturer has pled guilty to such fraud, "[i]f the gate had not been open, that event would have opened it." Woods v. Gliatech Inc., 218 F. Supp. 2d 802, 810 (W.D. Va. 2002). A further complication exists, given the PDA's ability to reach settlements with offending parties without any formal finding of fraud (or any admission of liability on the part of the misfeasants). See supra note 96. In that respect, the FDA retains significant discretionary authority. Critics have gone so far as to suggest that such discretionary power in effect shuts out private enforcement. See, e.g., Brief of Amicus Curiae AARP in Support of Respondents at 21, Kent, 128 S. Ct. 1168 (No. 06-1498), 2008 WL 189550, at *21 ("[R]equiring a formal FDA finding of fraud or decision to withdraw approval for a drug on the basis of safety concerns would render the [fraud caveat] provision [to statutory immunity] a dead letter.").