Fellner v. Tri-Union Seafoods, L.L.C.

• Decision Date: 19 August 2008
• Docket Number: No. 07-1238.,07-1238.
• Citation: 539 F.3d 237
• Parties: Deborah FELLNER, individually and on behalf of those similarly situated v. TRI-UNION SEAFOODS, L.L.C. d/b/a Chicken of the Sea Deborah Fellner, Appellant.
• Court: U.S. Court of Appeals — Third Circuit

539 F.3d 237

Deborah FELLNER, individually and on behalf of those similarly situated v. TRI-UNION SEAFOODS, L.L.C. d/b/a Chicken of the Sea Deborah Fellner, Appellant.

No. 07-1238.

United States Court of Appeals, Third Circuit.

Argued February 12, 2008.

Opinion Filed: August 19, 2008.

Kenneth A. Schoen, Scott H. Goldstein, Bonner, Kiernan, Trebach & Crociata, Parsippany, NJ, John A. Kiernan (Argued), Bonner, Kiernan, Trebach & Crociata, Boston, MA, Attorneys for Appellee.

William O. Crutchlow, Khalid Elhassan, Eichen, Levinson & Crutchlow, Edison, NJ, Adina H. Rosenbaum (Argued), Brian Wolfman, Public Citizen Litigation Group, Washington, DC, Attorneys for Appellant.

Before: SLOVITER, SMITH and STAPLETON, Circuit Judges.

OPINION OF THE COURT

STAPLETON, Circuit Judge:

Plaintiff Deborah Fellner filed this lawsuit against defendant Tri-Union Seafoods, LLC ("Tri-Union") in the Superior Court of New Jersey seeking damages for harm she allegedly sustained as a result of her consumption of methylmercury and other harmful compounds contained in Tri-Union's tuna fish products. The case was removed to federal court, and Tri-Union filed a motion to dismiss for failure to state a claim asserting that Fellner's lawsuit is preempted by regulatory actions of the United States Food and Drug Administration ("FDA"). The District Court granted the motion, ruling that Fellner's claims are preempted by the FDA's "regulatory approach" to the risks posed by mercury compounds in tuna fish. Because we conclude that the FDA has taken no regulatory action which preempts Fellner's lawsuit, we will reverse and remand for further proceedings.

I. Facts and Procedural Background

Fellner alleges that Tri-Union produces, cans and distributes Chicken-of-the-Sea brand tuna fish and that, from 1999 to 2004, her diet consisted almost exclusively of TriUnion's tuna products. She further avers that those products contained methylmercury and other harmful compounds that can result in mercury poisoning and that "[d]ue to the negligence and statutory violations of the Defendant ... Fellner contracted severe mercury poisoning and suffered extreme physical and emotional injuries." App. at 30a, ¶ 28. She seeks recovery under the New Jersey Products Liability Act, N.J.S.A. 2A:58C1, et seq. ("NJPLA"), based on Tri-Union's failure to warn of the risks incurred in consuming its products.¹

The factual landscape of this case is colored by recent litigation in California. On June 21, 2004, then-Attorney General of California, Bill Lockyer, filed a lawsuit against TriUnion and other defendants under California's "Proposition 65," CAL. HEALTH & SAFETY CODE § 25249.6, seeking an injunction and civil penalties for defendants' failure to warn consumers that their tuna products contain dangerous mercury compounds. While that suit was pending, the Commissioner of the FDA sent a letter to Mr. Lockyer expressing the opinion that the FDA's prior regulatory actions preempt the State's lawsuit. In the Commissioner's view, the defendants would be unable to comply both with that approach and state law and the existence of the lawsuit would "frustrate the [FDA's] carefully considered federal approach" to the issue of mercury in fish. See People v. Tri-Union Seafoods, 2006 WL 1544377 (Cal.Super.Ct. May 12, 2006) (taking judicial notice of the letter). In May 2006, following a bench trial, the Superior Court of California found the Attorney General's lawsuit preempted by federal law. People v. Tri-Union Seafoods, 2006 WL 1544384 (Cal.Super.Ct. May 11, 2006), appeal docketed, No. A116792 (Cal.Ct.App. 1st Dist. Feb. 20, 2007).

Tri-Union removed Fellner's lawsuit to the United States District Court for the District of New Jersey and filed a motion to dismiss for failure to state a claim accompanied by motions requesting that the Court take judicial notice of four documents: (1) a consumer advisory published by the FDA in 2004 regarding the risks of mercury in fish ("the Advisory"); (2) a "backgrounder" for the FDA's 2004 Advisory, which provides further information about those risks ("the backgrounder") (3) Section 504.0600 of the FDA's Compliance Policy Guide, a guideline recommending that the FDA initiate enforcement action if the concentration of mercury in fish exceeds "1 ppm" ("the Compliance Guide"); and (4) the above-described letter sent by the Commissioner of the FDA to the Attorney General of California ("the Commissioner's letter").

The District Court took judicial notice of the four documents submitted by defendant and granted defendant's motion to dismiss. Fellner v. Tri-Union Seafoods, 2007 WL 87633 (D.N.J.2007). It found that the FDA had implemented a "pervasive regulatory scheme" pertaining to the risks of methylmercury in fish consisting of the FDA's Advisory, backgrounder, Compliance Guide, and the Commissioner's letter. It concluded that the FDA had deliberately declined to require warnings in favor of a more "nuanced" and "balanced" approach consisting of targeted advisories, and that the state law duties relied upon by Fellner in her lawsuit would upset that approach. As a result, the Court dismissed the complaint, holding that the FDA's regulatory scheme regarding mercury in fish preempts Fellner's state law claims. She timely appealed.

II. Jurisdiction and Standard of Review

We have jurisdiction pursuant to 28 U.S.C. § 1291. We exercise plenary review of the District Court's order granting defendant's motion to dismiss. Santiago v. GMAC Mortgage Group, 417 F.3d 384, 386 (3d Cir.2005). When reviewing a motion to dismiss for failure to state a claim under Fed.R.Civ.P. 12(b)(6), we accept as true all well-pled factual allegations in the complaint and all reasonable inferences that can be drawn from them, and we affirm the order of dismissal only if the pleading does not plausibly suggest an entitlement to relief. Wilkerson v. New Media Tech. Charter Sch., 522 F.3d 315, 321-22 (3d Cir.2008).

III. Discussion

The sole question presented in this appeal is whether Fellner's state claim for damages is preempted by federal law. Tri-Union offers three distinct theories of preemption: (1) that the FDA has adopted a "pervasive regulatory approach" — embodied in the FDA's Advisory, backgrounder and internal enforcement guideline — with which Fellner's state lawsuit actually conflicts; (2) that the FDA has "reject[ed] the use of warning labels" in favor of a more "nuanced" approach — that is, that the FDA has reached a decision that warnings should not be regulated, a decision which preempts the state from entertaining a claim based on a duty to warn theory; and (3) that the FDA would have rejected any warning as "misbranding," a determination which preempts Fellner's failure-to-warn claim.

A. The Doctrine of Federal Preemption

The doctrine of federal preemption is rooted in the Supremacy Clause of the United States Constitution, U.S. Const. art. VI, cl. 2, which invalidates state laws that "interfere with, or are contrary to, federal law." Hillsborough County v. Automated Med. Labs., 471 U.S. 707, 712, 105 S.Ct. 2371, 85 L.Ed.2d 714 (1985) (quoting Gibbons v. Ogden, 22 U.S. 1 (9 Wheat. 1, 211), (1824)). As we recently explained,

[t]he Supreme Court has identified three major situations where there is preemption ... (1) "express" preemption, applicable when Congress expressly states its intent to preempt state law; (2) "field" preemption, applicable when "Congress' intent to pre-empt all state law in a particular area may be inferred [because] the scheme of federal regulation is sufficiently comprehensive" or "the federal interest is so dominant that the federal system will be assumed to preclude enforcement of state laws on the same subject;" and (3) "conflict" preemption, applicable when "state law is nullified to the extent that it actually conflicts with federal law," even though Congress has not displaced all state law in a given area.

Colacicco v. Apotex Inc., 521 F.3d 253, 261 (3d Cir.2008) (quoting Hillsborough County, 471 U.S. at 713, 105 S.Ct. 2371). See also English v. General Elec. Co., 496 U.S. 72, 78-79, 110 S.Ct. 2270, 110 L.Ed.2d 65 (1990) (summarizing the three types of preemption). Tri-Union has not argued, nor could it, that Fellner's lawsuit is expressly preempted by the Food, Drug and Cosmetics Act ("FDCA") or by federal regulation.² Similarly, we do not interpret TriUnion's brief as asserting a field preemption claim, and any such claim would be unavailing.³ If preemption exists in this case it must be conflict preemption.

As the Supreme Court frequently reiterates, in all cases "preemption fundamentally is a question of congressional intent." English, 496 U.S. at 78-79, 110 S.Ct. 2270. See also Medtronic v. Lohr, 518 U.S. 470, 485, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) ("`[t]he purpose of Congress is the ultimate touchstone' in every preemption case") (citation omitted). However, "state laws can be preempted by federal regulations as well as by federal statutes." Hillsborough County, 471 U.S. at 713, 105 S.Ct. 2371. Where Congress has delegated the authority to regulate a particular field to an administrative agency, the agency's regulations issued pursuant to that authority have no less preemptive effect than federal statutes, assuming those regulations are a valid exercise of the agency's delegated authority. Fidelity Fed. Savings and Loan Ass'n v. de la Cuesta, 458 U.S. 141, 153-54, 102 S.Ct. 3014, 73 L.Ed.2d 664 (1982).

Although federal administrative law as well as Congressional enactments are the supreme law of the land, we must reiterate, lest the analysis become unmoored, that it is federal law which preempts contrary state law; nothing short of federal law can have that effect. The Supreme Court's longstanding interpretation of the Supremacy Clause, and indeed the Supremacy Clause itself, mandate this principle:

Article VI of the Constitution provides that the laws of the United States "shall be the supreme Law of...