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Contrary to the expectations of many, the FDA Amendments Act of 2007 (FDAAA), signed into law by the President in late September, does not contain any provision expressly preempting state laws. The House Subcommittee on Health eliminated proposed language that would have precluded FDA act’s preemption of state law. The proposed language was:
“Nothing in this act or the amendments made by this act may be construed as having any legal effect on any cause of action for damages under the law of any state (including statutes, regulations, and common law.”
Without this language, the question is: Does the Act preempt conflicting state law?
What Does FDA Think?
There are three ways federal law can preempt contrary state law: (i) express preemption; (ii) field preemption; and (iii) conflict preemption. In January 2006, FDA issued a Final Rule revising the content and format requirements for prescription drug labeling. In the preamble to that rule, FDA said its decisions on prescription drug labeling preempt “conflicting or contrary” state law requirements, whether arising by statute, administrative rule, or product liability actions.
FDA’s preamble invokes conflict preemption – an implied preemption when state and federal law conflict with one another. See Lorillard Tobacco Co. v. Reilly, 533 U.S. 525, 121 S. Ct. 2404, 2414 (2001); Crosby v. National Foreign Trade Council, 530 U.S. 363, 372-73 (2000); English v. General Elec. Co., 496 U.S. 72, 78-79 (1990). Conflict preemption occurs when, “‘under the circumstances of [a] particular case, [the challenged state law] stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress’” or “where it is impossible for a private party to comply with both the state and federal law.” Crosby, 530 U.S. at 372-73 (citation omitted); Geier v. American Honda Motor Co., Inc., 529 U.S. 861, 873 (2000); English, 496 U.S. at 79.
What Do the Courts Think?
Since the FDA issued the Final Rule in January 2006, courts have split as to whether to apply conflict preemption to conflicting state laws.
Several federal district courts, one circuit court, and two state courts have ruled that FDA preempts state law.1 [Please read our FDA Alert on the recent Third Circuit decision expanding FDA preemption.] In one recent federal decision, In re Bextra & Celebrex Marketing Sales Practices & Product Liability Litig., 2006 WL 2374742 (N.D. Cal. Aug. 16, 2006), Judge Charles R. Breyer held that FDA’s labeling decisions preempt state consumer fraud actions when the evidence shows that FDA considered and rejected the labeling issue raised under state law.
On the other hand, six state courts and six federal courts have declined to apply preemption principles to state law claims.2 The Supreme Court accepted certiorari on one of these cases late in September. See Warner Lambert Co. v. Kent, ___ U.S. ___, 2007 WL 1420397, *1 (Sept. 27, 2007).
And finally, federal courts in North Carolina, Pennsylvania, and Kentucky have issued decisions that decline to impose preemption but contain dicta supporting preemption on facts similar to those in the Bextra and Celebrex litigation. In addition, allegations based on conduct that occurred in the midst of the labeling approval process would also result in preemption.3
What Does Congress Think?
Congress is also conflicted as to whether the new FDAAA preempts conflicting state law. Some senators have stated that the Act preempts conflicting state law. Senator Tom Coburn (R-OK) said during the floor debate that the “newly expanded role of the FDA does and should preempt state law when it comes to drug safety and labeling.” He explained that “[i]n order to ensure scientific drug safety the last thing that we need is the regulatory nightmare of every State court being a mini-FDA. Appropriate preemption of State jurisdiction includes not only claims against manufacturers, but also against health care practitioners for claims related to dissemination of risk information to patients beyond what is included in the labeling.”
No other legislator disputed that conflict preemption might apply. Instead, senators noted that the new Act does not preempt the entire field of prescription drug labeling, nor does the new Act expressly preempt state law.
Senator Edward M. Kennedy (D-MA): “We do not believe that the regulatory scheme embodied in this act is comprehensive enough to preempt the field or every aspect of state law. This legislation improves FDA oversight of postmarket drug safety, and does not undermine or preempt the efforts by injured patients to seek redress under State product liability law. 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.”
Senator Leahy (D-VT): “Congress has again decided that we are not preempting State law regarding the responsibility of drug manufacturers to immediately notify consumers of dangers without waiting for the FDA to act.”
What Happens Next?
Congress’s failure to include a general preemption provision in the Act means the plaintiffs’ bar will continue to argue that federal law does not preempt state product liability or consumer fraud actions. Meanwhile, pharmaceutical manufacturers and prescription drugs sponsors will continue to argue that conflict preemption at a minimum – if not field preemption – applies and preempts state law actions based on the contents of prescription drug labels. And, of course, the Supreme Court’s impending decision in Warner-Lambert v. Kent will add to, if not resolve, the prescription drug preemption debate.
1 Pennsylvania Employees Benefit Trust Fund v. Zeneca Inc., ___ F.3d ___, No. 05-5340, 2007 WL 2376312 (3d Cir. Aug, 17, 2007) (holding that FDA has “exclusive authority” to regulate prescription drug advertising);
Tucker v. SmithKline Beecham Corp., No. 1:04-cv-1748-DFH-WTL, slip op. at *12 (S.D. Ind. Sept. 19, 2007) (comparing judicial holdings since Final Rule, noting trend against preemption, but ultimately holding that where there is a “particularly clear showing of conflict” preemption is appropriate);
Bruesewitz v. Wyeth, Inc., 2007 WL 2463378 (E.D. Pa. Aug. 24, 2007) (vaccine case);
In re Baycol Prods. Litig., 495 F. Supp. 2d 977 (D. Minn. 2007);
Prohias v. Pfizer, Inc., 490 F. Supp. 2d 1228 (S.D. Fla. 2007);
Sykes v. Glaxo-SmithKline, 484 F. Supp. 2d 289 (E.D. Pa. 2007) (vaccine case);
Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514 (E.D. Pa. 2006);
Brockert v. Wyeth Pharmaceuticals, 2007 WL 2077554 (Tex. Dist. Jan. 31, 2007);
Prohias v. AstraZeneca Pharmaceuticals, L.P., 958 So.2d 1054 (Fla. App. 2007);
Militrano v. Lederle Labs., 810 N.Y.S.2d 506 (N.Y.A.D. 2006) (vaccine case); Price v. Cook, 2007 WL 2154766 (W. Va. Cir. July 9, 2007);
Ledbetter v. Merck & Co., 2007 WL 1181991 (Tex. Dist. Apr. 20, 2007);
Conte v. Wyeth, Inc., 2006 WL 2692469 (Cal. Super. Sept. 15, 2006);
Abramowitz v. Cephalon, Inc., 2006 WL 560639 (N.J. Super. Mar. 3, 2006).
2 Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), cert granted,
Warner-Lambert Co. v. Kent, ___ U.S. ___, 2007 WL 1420397, *1 (Sept. 25, 2007);
In Re: Vioxx Products Liability Litig., ___ F. Supp. 2d ___, 2007 WL 1952964 (E.D. La. July 3, 2007);
In re Zyprexa Products Liability Litig., 489 F. Supp. 2d 230 (E.D.N.Y. 2007);
Barnhill v. Teva Pharmaceuticals USA Inc., 2007 U.S. Dist. Lexis 44718 (S.D. Ala. Apr. 24, 2007);
Jackson v. Pfizer, Inc., 432 F. Supp. 2d 964 (D. Neb. 2006);
Laisure-Radke v. Par Pharmaceutical, Inc., 2006 WL 901657 (W.D. Wash. Mar. 29, 2006);
Strong v. American Cyanamid Co., ___ S.W.3d ___, 2007 WL 2445938 (Mo. App. Aug. 28, 2007) (vaccine case);
Ferrari v. American Home Products Corp., 2007 WL1933129 (Ga. App. July 5, 2007) (vaccine case);
Deutsch v. Wyeth, Inc., 2007 WL 2060072 (N.J. Super. Law Div. June 22, 2007);
Cona v. Merck & Co., Nos. ATL-L-3553-05, ATL-L-1296-05 (N.J. Super. Law Div. June 8, 2007) (not on either service);
Kelly v. Wyeth, 2007 WL 1302589 (Mass. Super. Apr. 12, 2007);
Levine v. Wyeth, ___ A.2d ___, 2006 WL 3041078 (Vt. Oct. 27, 2006);
McNellis v. Pfizer, Inc., 2006 WL 2819046 (D.N.J. Sept. 29, 2006); and
Coutu v. Tracy, 2006 WL 1314261 (R.I. Super. May 11, 2006).
3 Sarli v. Mylan Bertek Pharmaceuticals Inc., 2007 WL 2111577 (M.D.N.C. July 19, 2007) (“If the FDA determined that a warning was not warranted based on the evidence that had been submitted to the FDA, . . . , then a claim asserting the impropriety of such failure to include the warning at issue would be preempted.”);
Weiss v. Fujisawa Pharmaceutical Co., 464 F. Supp. 2d 666 (E.D. Ky. 2006) (“FDA's position [requiring preemption] is persuasive insofar as it rejects failure-to-warn claims (1) based on conduct that allegedly occurred prior to and during the labeling approval process and (2) based on proposed warnings that FDA has specifically considered and rejected as scientifically unsubstantiated.”); and
Perry v. Novartis Pharmaceutical Corp., 456 F. Supp. 2d 678 (E.D. Pa. 2006) (“Even where compliance with both federal and state law is possible, preemption may be found where the existence of state law tort suits would disrupt the statutory and regulatory scheme that Congress envisioned.”).