Lead Opinion
Allen Lefaivre, individually and on behalf of all others similarly situated, brought this potential class action suit against KV Pharmaceutical Company, ETHEX Corporation, and Ther-Rx Corporation (collectively, “KV”). KV manufactures a hypertension medication called Metoprolol Succinate ER. Lefaivre alleged that KV breached its implied warranty of merchantability and violated the Missouri Merchantability Practices Act (MMPA) by failing to manufacture the medication in comрliance with federal regulations. In response, KV moved to dismiss the suit, asserting that the claims were essentially claims for violation of federal regulations themselves and that no private cause of action existed. The district court held that Lefaivre’s state law claims were preempted by federal law because the claims were based entirely on violations of federal regulations, and the enforcement of federal regulations is solely the prоvince of the federal government. We hold that Lefaivre’s claims are not impliedly preempted and accordingly reverse and remand.
I. Background
KV manufactures Metoprolol Succinate ER in Missouri, and markets and distributes it throughout the United States. Lefaivre, a resident of Rhode Island, had a prescription for the medication and purchased it several times at retail pharmacies in Rhode Island.
On March 2, 2009, the Food and Drug Administration (FDA) filed a complaint against KV alleging that KV had not manufactured the medication in compliance with FDA standards under certain provisions of Chapter V of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 351(a)(2)(B). On March 6, 2009, the FDA and KV jointly filed a Consent Decree of Permanent Injunction (“Consent Decree”) that settled the FDA’s complaint with KV. In the Consent Decree, KV neither admitted nor denied the FDA’s claims.
KV stipulated as part of the Consent Decree that it had sold drugs that were “adulterated” as defined by 21 U.S.C. § 351(a)(2)(B), meaning that the drugs were mаnufactured, processed, packed, labeled, held, and distributed in violation of the FDA’s current good manufacturing practice (cGMP) requirements. KV acknowledged that it had not used proper quality control procedures when manufacturing the medication. It also stipulated that some of the medication sold to retail pharmacies had been misbranded in violation of federal regulations. KV agreed to destroy the remaining stock of “adulterated” drugs and issue a recall for all stocks of the medication sold to retailers between May 2008 and February 3, 2009. KV issued the recall notice “at the retail level.” A retail-level recall instructs all retailers that had purchased the medication to return all unsold product to KV. The Consent Decree did not require KV to distribute its recall notice to individual purchasers of the medication, and it did not do so.
Lefaivre filed suit against KV alleging (1) a breach of the implied warranty of merchantаbility and (2) violations of the MMPA. Specifically, Lefaivre alleged that
KV moved to dismiss the suit, asserting that the claims were essentially claims for violation of federal regulations themselves and that no private cause of action existed. The district court held that Lefaivre’s state law claims were preempted by federal law because the claims were based entirely on violations of federal regulations and the enforcement of federal regulations is solely the province of the federal government.
II. Discussion
On appeal, Lefaivre asserts that the district сourt’s ruling leaves him and all other purchasers of the adulterated medication without a legal remedy for economic injuries. According to Lefaivre, the district court’s determination that the FDCA impliedly preempts his state law causes of action is without legal support and contrary to Wyeth v. Levine, 555 U.S. 555,
In response, KV maintains that the district court simply applied a basic legal doctrine — that Lefaivre may not convert FDCA violations into private causes of action — to dismiss Lefaivre’s claims. According to KV, the Supreme Court in Wyeth left this doctrine intact.
“The general law of preemption is grounded in the Constitution’s command that federal law ‘shall be the supreme Law of the Land.’ ” In re Aurora Dairy Corp. Organic Milk Mktg. & Sales Practices Litig.,
First, Congress does not cavalierly preempt state-law causes of action. In all pre-emption cases, and particularly in those in which Congress has legislated in a field which the States have traditionally occupied, we start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress. Second, congressional purpose is the ultimate touchstone in every preеmption case.
Id. (internal quotations, alterations, and citation omitted).
Implied preemption exists where a federal statutory or regulatory scheme is so pervasive in scope that it occupies the field, leaving no room for state action— this is termed field preemption. Implied preemption also occurs where state law has not been completely displaced but is superseded tо the extent that it conflicts with federal law — this is known as conflict preemption.
Id. (internal quotation and citation omitted). There are two types of conflict preemption — impossibility preemption and obstruction preemption. See Wis. Pub. Intervenes v. Mortier,
In determining whether Lefaivre’s claims are impliedly preempted, we must determine Congress’s purpose and intent in enacting the FDCA. To determine Congress’s intent, we “may consider the statute itself and any regulations enacted pursuant to the statute’s authority.” Aurora,
Fortunately, the Court extensively discussed Congress’s purpose with regard to 'drugs and drug labeling in Wyeth, stating:
In 1906, Congress enacted its first significant public health law, the Federal Food and Drugs Act, ch. 3915, 34 Stat. 768. The Act, which prohibited the manufacture or interstate shipment of adulterated or misbranded drugs, supplemented the protection for consumers already provided by state regulation and common-law liability. In the 1930’s, Congress became increasingly concerned about unsafe drugs and fraudulent marketing, and it enacted the Federal Food, Drug, and Cosmetic Act (FDCA), ch. 675, 52 Stat. 1040, as amended, 21 U.S.C. § 301 et seq. The Act’s most substantial innovation was its provision for premarket аpproval of new drugs. It required every manufacturer to submit a new drug application, including reports of investigations and specimens of proposed labeling, to the FDA for review. Until its application became effective, a manufacturer was prohibited from distributing a drug. The FDA could reject an application if it determined that the drug was not safe for use as labeled, though if the agency failed to act, an application became effective 60*940 days after the filing. FDCA, § 505(c), 52 Stat. 1052.
As it enlarged the FDA’s powers to “protect the public health” and “assure the safety, effectiveness, and reliability of drugs,” [76 Stat.] 780, Congress took care to preserve state law. The 1962 amendments added a saving clause, indicating that a provision of state law would only be invalidated upon a “direct and positive conflict” with the FDCA. § 202, id., at 793. Consistent with that provision, state common-law suits “continued unabated despite ... FDA regulation.” Riegel v. Medtronic, Inc., 552 U.S. [312], [340],128 S.Ct. 999 , 1017,169 L.Ed.2d 892 (2008) (GINSBURG, J., dissenting); see ibid., n. 11 (collecting state cases). And when Congress enacted an express pre-emption provision for medical devices in 1976, see § 521, 90 Stat. 57k (codified at 21 U.S.C. § 360k(a)), it declined to enact such a provision for prescription drugs.
Building on its 1906 Act, Congress enacted the FDCA to bolster consumer protection against harmful products. See Kordel v. United States,335 U.S. 345 , 349,69 S.Ct. 106 ,93 L.Ed. 52 (1948); United States v. Sullivan,332 U.S. 689 , 696,68 S.Ct. 331 ,92 L.Ed. 297 (1948). Congress did not provide a federal remedy for consumers harmed by unsafe or ineffective drugs in the 1938 statute or in any subsequent amendment. Evidently, it determined that widely available state rights of action provided appropriate relief fоr injured consumers. It may also have recognized that state-law remedies further consumer protection by motivating manufacturers to produce safe and effective drugs and to give adequate warnings.
If Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express pre-emption provision at some point during the FDCA’s 70m¡ear history. But despite its 1976 enactment of an express pre-emption provision for medical devices, see § 521, 90 Stat. 574 (codified at 21 U.S.C. § 360k(a)), Congress has not enacted such a provision for prescription dmgs. See Riegel, 552 U.S. at [327],128 S.Ct. at 1009 (“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”). Its silence on the issue, coupled with its certain awareness of the prevalence of state tort litigation, is powerful evidence that Congress did not intend FDA ovеrsight to be the exclusive means of ensuring drug safety and effectiveness. As Justice O’Connor explained in her opinion for a unanimous Court: “The case for federal pre-emption is particularly weak where Congress has indicated its awareness of the operation of state law in a field of federal interest, and has nonetheless decided to stand by both concepts and to tolerate whatever tension there [is] between them.” Bonito Boats, Inc. v. Thunder Craft Boats, Inc.,489 U.S. 141 , 166-167,109 S.Ct. 971 ,103 L.Ed.2d 118 (1989) (internal quotation marks omitted); see also supra, at 1194 (discussing the presumption against pre-emption).
* * *
In keeping with Congress’ decision not to pre-empt common-law tort suits, it appears that the FDA traditionally regarded state law as a complementary form of drug regulation. The FDA has limited resources to monitor the 11,000 drugs on the market, and manufacturers have superior access to information*941 about their drugs, especially in the post-marketing phase as new risks emerge. State tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly. They alsо serve a distinct compensatory function that may motivate injured persons to come forward with information. Failure-to-warn actions, in particular, lend force to the FDCA’s premise that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times. Thus, the FDA long maintained that state law offers an additional, and important, layer of consumer protection that complements FDA regulation.
The Court’s comments in Wyeth regarding drugs and drug labeling strongly imply that field preemption does not apply in the present case. Specifically, in relating the history of federal regulation of drugs and drug labeling, the Court recognized that when Congress first enacted the Federal Food and Drugs Act, Congress “supplemented the protection for consumers already provided by state regulation and common-law liability.” Id. at 1195. Furthermore, when Congress enacted an express preemption provision for medical devices, it declined to do so for prescriрtion drugs. Id. at 1196. Nor has Congress ever provided a federal remedy for consumers harmed by ineffective drugs. “Evidently, it determined that widely available state rights of action provided appropriate relief for injured consumers. It may also have recognized that state-law remedies further consumer protection by motivating manufacturers to produce safe and effective drugs and to give adequate warnings.” Id. at 1199-1200. Thus, we conclude the “federal statutory or regulatоry scheme” in the present case is not “so pervasive in scope that it occupies the field.” Aurora,
Nor does conflict preemption — impossibility or obstacle — apply in the present case. First, it is not physically impossible for KV tо comply with both federal and state law. See Wis. Pub. Intervenor,
Nevertheless, KV maintains that Buck-man forecloses Lefaivre’s state law claims. In Buckman, the plaintiffs claimed injuries arising from the use of orthopedic bone screws in their spines.
The Court held “that the plaintiffs’ state-law fraud-on-the-FDA claims conflicted] with, and [were] therefore impliedly pre-empted by, federal law.” Id. at 348,
Thereafter, the Court explained that the “state-law fraud-on-the-FDA claims” conflicted with federal law because “the federal statutory scheme amply empowers the FDA to punish and deter fraud against the Administration, and that this authority is used by the Administration to achieve a somewhat delicate balance of statutory objectives.” Id. at 348,
inevitably conflict with the FDA’s responsibility to police fraud consistently with the Administration’s judgment and objectives. As a practical matter, complying with the FDA’s detailed regulatory regime in the shadow of 50 Statеs’ tort regimes will dramatically increase the burdens facing potential applicants — burdens not contemplated by Congress in enacting the FDCA and the MDA. Would-be applicants may be discouraged from seeking § 510(k) approval of devices with potentially beneficial off-label uses for fear that such use might expose the manufacturer or its associates (such as petitioner) to unpredictable civil liability. In effect, then, fraud-on-the-FDA claims could cause the Administration’s reporting requirements to deter off-label use despite the fact that the FDCA expressly disclaims any intent to directly regulate the practice of medicine, see 21 U.S.C. § 396 (1994 ed., Supp. V), and even though off-label use is generally accepted.
Id. at 350-51,
Finally, the Court rejected the plaintiffs’ attempt to characterize both the claims at issue in Medtronic[, Inc. v. Lohr,518 U.S. 470 [116 S.Ct. 2240 ,135 L.Ed.2d 700 ] (1996) ] (common-law negligence action against the manufacturer of an allegedly defective pacemaker lead) and the fraud claims here as “claims arising from violations of FDCA requirements.”*943 Brief for Respondent 38. Notwithstanding the fact that Medtronic did not squarely address the question of implied pre-emption, it is clear that the Medtronic claims arose from the manufacturer’s allegеd failure to use reasonable care in the production of the product, not solely from the violation of FDCA requirements. See518 U.S. at 481 ,116 S.Ct. 2240 . In the present case, however, the fraud claims exist solely by virtue of the FDCA disclosure requirements. Thus, although Medtronic can be read to allow certain state-law causes of actions that parallel federal safety requirements, it does not and cannot stand for the proposition that any violation of the FDCA will support a state-law clаim. In sum, were plaintiffs to maintain their fraud-on-the-agency claims here, they would not be relying on traditional state tort law which had predated the federal enactments in questions. On the contrary, the existence of these federal enactments is a critical element in their case. For the reasons stated above, we think this sort of litigation would exert an extraneous pull on the scheme established by Congress, and it is therefore pre-empted by that scheme.
Id. at 352-53,
Justicе Stevens, joined by Justice Thomas, concurred in the judgment, explaining that
[t]his would be a different case if, prior to the instant litigation, the FDA had determined that petitioner had committed fraud during the § 510(h) process and had then taken the necessary steps to remove the harm-causing product from the market. Under those circumstances, respondent’s state-law fraud claim would not depend upon speculation as to the FDA’s behavior in a counter-factual situation but would be grounded in the agency’s explicit actions. In such a case, a plaintiff would be able to establish causation without second-guessing the FDA’s decisionmaking or overburdening its personnel, thereby alleviating the Government’s central concerns regarding fraud-on-the-agency claims.
If the FDA determines both that fraud has occurred and that such fraud requires the removal of a product from the market, state damages remedies would not encroach upon, but rather would supplement and facilitatе, the federal enforcement scheme. Cf. Medtronic, Inc. v. Lohr,518 U.S. 470 , 495,116 S.Ct. 2240 ,135 L.Ed.2d 700 (1996) (holding that the presence of a state-law damages remedy for violations of FDA requirements does not impose an additional requirement upon medical device manufacturers but “merely provides another reason for manufacturers to comply with ... federal law”); id. at 513,116 S.Ct. 2240 (O’CONNOR, J., concurring in part and dissenting in part) (same).
Id. at 354,
The hypothetical scenario that Justice Stevens conceived of in Buckman is virtually identical to the present case. Here, the Consent Decree between the FDA and KV established that KV had, in fact, manufactured “adulterated” medication in violation of cGMP requirements. In compliance with the Consent Decree, KV destroyed its remaining stock of “adulterated” drugs and issued a recall for all stocks of the medication sold to retailers. Thus, Lefaivre’s state law claims are not “depend[ent] upon speculation as to the FDA’s behavior” but instead are “grounded in the agency’s explicit actions. In such a case, [Lefaivre] would be able to establish causation without second-guessing the FDA’s decisionmaking or overbur
Furthermore, the present case is distinguishable from Buckman because Lefaivre’s state-law claims are not fraud-on-the-FDA claims, as they “focus on [harm] that is allegedly perpetrated against [consumers] rather than the FDA.” Couick v. Wyeth, Inc., No. 3:09-cv-210-RJC-DSC,
The Court in Buckman specifically applied field preemption to state-law fraud-on-the-FDA claims because policing fraud against federal agencies “is hardly a field which the States have traditionally occupied.” Buckman,
III. Conclusion
Accordingly, we reverse the judgment of the district court and remand for further proceedings consistent with this opinion.
Notes
. Nothing in this opinion prohibits KV from raising, or the district court from considering on remand, whether Lefaivre’s pleading states no independent claim under state law upon which relief can be granted under Federal Rule of Civil Procedure 12(b)(6).
Concurrence Opinion
concurring.
I concur in the result reached by the court.