Preemption Of Failure-To-Warn Claims: The Battle Inside And Outside The Courtroom

Sunday, October 1, 2006 - 01:00
John P. Lavelle, Jr.
Anne G. Sweeny

In January 2006, the FDA issued its much-anticipated new prescription drug labeling rule. The rule states the agency's position that FDA approval of labeling preempts many state law failure-to-warn claims. If generally adopted, the FDA's position will eliminate many of the most common tort claims attacking the labeling of prescription drugs.

In courtrooms across the country, pharmaceutical manufacturers, plaintiffs and their lawyers are now waging battle over the legal significance of the FDA's pronouncement. At the same time, opponents of preemption have turned up the heat in a variety of forums seeking to overturn the agency's position by political pressure or legislation. The ultimate resolution of this issue is of enormous importance to pharmaceutical manufacturers as well as to the plaintiffs' personal injury bar, each of which have substantial financial stakes riding on the outcome. Because the challenges to the FDA's position raise fundamental questions concerning the deference owed to an agency's view on preemption, the shots fired in this battle will reverberate far and wide.

The FDA's Position On Preemption

The FDA published its Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products in the Federal Register. 71 Fed. Reg. 3922 (Jan. 24, 2006). In what has been referred to as the "preemption preamble" to this Final Rule, the agency states that "under existing preemption principles, FDA approval of labeling preempts conflicting or contrary State law." Id. at 3934. Without preemption, the FDA explains that not only would its "role as the expert Federal agency responsible for evaluating and regulating drugs" be threatened, but patient safety would be undermined because "[e]xaggeration of risk could discourage appropriate use of a beneficial drug." Id. at 3935.

The FDA addresses and rejects two familiar arguments often made against preemption. The FDA states that the regulations do not merely establish "minimum" safety standards. Id . at 3934-3935. Rather, the labeling regulations "establish both a 'floor' and a 'ceiling.'" Id. at 3935. Moreover, the FDA rejects the argument that a manufacturer may strengthen warnings without prior FDA approval, declaring that "the determination whether labeling revisions are necessary is, in the end, squarely and solely FDA's under the act." Id. at 3934.

To further guide manufacturers and courts, the FDA identifies six specific types of claims that the Rule would preempt, including that a manufacturer:

  • "fail[ed] to put in Highlights or otherwise emphasize" information in the label;

  • "fail[ed] to include in an advertisement" information contained in the label where the manufacturer has complied with the FDA's draft guidance on direct-to-consumer advertising;

  • "fail[ed] to include contraindications or warnings that are not supported by evidence that meets the standards" of the rule;

  • "fail[ed] to include in labeling or in advertising a statement," proposed to but not required by the FDA at the time of plaintiff's alleged injury;

  • failed to include a statement in labeling or advertising, "which FDA has prohibited;" and

  • "breached an obligation to plaintiff by making statements that FDA approved for inclusion in the drug's label" unless the FDA has found that the manufacturer "withheld material information relating to the statement."
  • Id. at 3935-3936.

    The FDA states that the preamble "represents the government's long standing views" on the issue. Id. at 3934. But not everyone agrees. One federal court finding in favor of preemption has even termed the preamble a "180-degree reversal of the [FDA's] prior position." In re: Bextra and Celebrex Mktg. Sales Practices and Prod. Liab. Litig., 2006 WL 2374742, at *8 (N.D. Cal. Aug. 16, 2006). Whether or not the preamble states a policy change is one of the hotly debated issues in the litigation spawned by publication of the final rule.

    Litigation On Legal Significance Of FDA's Stated Position

    Just eight months later, a substantial body of case law already has developed interpreting the preamble. As of the press date of this article, seven courts have issued opinions considering the Rule. Four have found that the Rule preempts state "failure-to-warn" claims.1 Three have held that the Rule has no preemptive impact.2 Behind this split in authority lay two fundamentally different viewpoints of the significance of the FDA's pronouncement.

    The opinion providing the most detailed analysis of both sides of the debate so far is the decision of the United States District Court for the Eastern District of Pennsylvania in Colacicco adopting the FDA's preamble. The plaintiff there alleged that the defendant drug manufacturers failed to warn adequately of the increased risk of suicide associated with the antidepressant drug Paxil. Colacicco, 432 F.Supp.2d at 520. The Court dismissed plaintiff's state failure-to-warn claims, explaining that, under principles of implied preemption and Third Circuit precedent, the FDA's stated position on preemption was entitled to "significant deference." Id. at 529.

    The Court disagreed with plaintiff's contention that the FDA's inconsistent statements of policy on preemption mandated against deference. The plaintiff argued that, in the initial version of the Final Rule, published in 2000, the FDA stated that its regulations are "minimum standards" that "do not preempt state tort law." Id. at 530 (quoting 65 Fed. Reg. 81082, 81103 (Dec. 22, 2000)). Although the court regarded the FDA's December 2000 statement "problematic" and "difficult to reconcile," the Court stated that a federal agency's initial interpretation "is not instantly carved in stone." Moreover, the Court found it "significant" that after the year 2000, the FDA "has been very consistent" in its position, espousing preemption in amicus briefs the agency filed in two federal court cases, Kallas v. Pfizer, Inc., No. 2:04-cv-0998 (D. Utah filed Sept. 15, 2005) and Motus v. Pfizer, Inc., 2002 WL 3230384 (9th Cir. filed Sept. 3, 2002). Id. at 531-532.

    The Colacicco Court also flatly rejected the plaintiff's contention that the preemption preamble amounts to "mere legal argument" and, therefore, should be ignored. Id. at 530. The court held that, under Supreme Court precedent, a federal agency may properly communicate preemptive intent through "amicus briefs, preambles and interpretive rules." Moreover, the Court found that it did not have the authority to second guess the FDA, to which Congress delegated the regulation of prescription drugs, including final decisions about their labeling.

    Finally, the Court held, contrary to plaintiff's contention, that the preemption preamble could be applied retroactively. Because the preemption preamble simply clarified the FDA's "longstanding views on preemption," the Court characterized the preamble as an "interpretive rule," rendering retroactivity concerns "irrelevant." Moreover, the Court explained, even if the preamble did not apply retroactively the Court would have found preemption anyway based on the views previously expressed by the FDA in its amicus briefs in Kallas and Motus. Id. at 534-535.

    The district court's decision in Colacicco will not be the final word, as an appeal to the Third Circuit is pending. Appeals have been sought in other cases as well. For example, Pfizer has filed a motion to vacate, or in the alternative a motion for certification of interlocutory appeal, in McNellis v. Pfizer, Inc., 2005 WL 3752269 (D.N.J. Dec. 29, 2005), a case decided just prior to the issuance of the FDA's Final Rule in January 2006. The first appellate decisions addressing the preamble should come by early 2007.

    The Battle Outside The Courtroom

    Meanwhile, opponents of preemption have taken up the fight outside the courtroom. Plaintiffs' attorneys, congressional Democrats, the National Conference of State Legislatures, and consumer advocacy groups have sharply criticized the Rule as an attempt by the Bush Administration to curry favor with big industry. Senator Edward M. Kennedy (D-MA) and Representative Maurice Hinchey (R-NY) have promised to fight preemption through legislation if necessary. See FDA Labeling Rule Faces Opposition Over Preemption , Generic Line, Vol. 23, No. 2 (Jan. 25, 2006), Moreover, Congressmen Henry A. Waxman (D-CA), John Dingell (D-MI), and Sherrod Brown (D-OH) wrote to Michael Leavitt, Secretary of Health and Human Services, on February 23, 2006, opposing the preemption of state product liability laws involving drug labeling or advertising.3

    The National Conference of State Legislatures ("NCSL") has called federal preemption of state authority "a growing concern," and a "backdoor way to impose the will of special interests on state public policy." Federal Preemption of State Authority a Disturbing and Growing Trend (April 6, 2006), The NCSL argues the preemption preamble violates Executive Order 13132, which requires the FDA to consult with NCSL before promulgating a final rule in order to minimize any preemptive impact. See FDA Final Rule on Prescription Drug Labeling (Jan. 19, 2006), NCSL is reportedly considering suing the FDA over the Final Rule. See FDA Labeling Rule Under Fire , Drug Industry Daily, Vol. 5, No. 13 (Jan. 19, 2006),

    The consumer advocacy group Public Citizen has also opposed the preemption preamble, calling it a "sneak attack on consumer rights" by President Bush. FDA's Drug Label Rule Fails to Guarantee Access to Vital Information and Includes 'Sneak Attack' on Patients' Legal Rights (Jan. 18, 2006), Even the Tort Trial and Insurance Practice Section ("TIPS") of the American Bar Association briefly considered, but ultimately withdrew, a resolution opposing the promulgation by federal agencies of rules preempting state tort claims. See ABA Tort Trial and Insurance Practice Section, Report to the House of Delegates, No. 103 (Aug. 2006),


    The battle over whether the FDA's pronouncement on preemption is entitled to deference will be waged in many courtrooms in the months to come. It remains to be seen whether a consensus builds among the courts - as, for example, the overwhelming majority of federal and state courts has now recognized that FDA premarket approval of a medical device preempts most state law tort claims. Ultimate resolution of the issue may depend on the United States Supreme Court, Congress, or even the 2008 Presidential election. For now, however, the preemption fight continues, with the stakes high and the outcome uncertain.1 Ackerman v. Wyeth Pharm., No. 4:05CV84, slip op., at 11 (E.D. Tex. Sept. 8, 2006); In re: Bextra, 2006 WL 2374742, at *10-12 (N.D. Cal. Aug. 16, 2006) (finding that the Rule preempts state failure-to-warn claims, but not false advertising claims); Colacicco v. Apotex, Inc., 432 F.Supp.2d 514, 529-538 (E.D. Pa. 2006); Abramowitz v. Cephalon, Inc., 2006 WL 560639, at *3 (N.J. Super. Ct. March 3, 2006).
    2 Jackson v. Pfizer, Inc., 432 F.Supp.2d 964, 968-969, fn.3 & fn.4 (D. Neb. 2006); Laisure-Radke v. Par Pharm., Inc., 2006 WL 901657, at *3, *6 (W.D. Wash. March 31, 2006); Coutu v. Tracy, 2006 WL 1314261, at *3-*4 (R.I. Super. Ct. May 11, 2006).
    3 This letter was cited by and attached as an exhibit to plaintiffs' response in opposition to Pfizer's motion to vacate, or in the alternative for interlocutory appeal, in the McNellis case. See Pl. Br. In Opp., 2006 WL 1042665 (D.N.J. filed March 2, 2006).

    John P. Lavelle, Jr. is Partner-in-Charge of the Product Liability and Mass Tort Practice Group at Ballard Spahr Andrews & Ingersoll, LLP. Anne G. Sweeny is staff attorney in the Group. Lawyers in Ballard's Product Liability and Mass Tort Group have extensive experience litigating product liability cases across the United States in the state and federal courts as national, regional, or local counsel for our clients.

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