On January 24, 2006, the U.S. Food and Drug Administration (FDA) issued a Final Rule entitled Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 71 Fed. Reg. 3922 (Jan. 24, 2006). In the now-famous preamble to that Final Rule, the FDA stated its view that “… under existing preemption principles, FDA approval of labeling under the act, whether it be in the old or new format, preempts conflicting or contrary State law.”   The preamble contains a detailed explanation of why the FDA believes that allowing certain state tort law claims for failure to warn would conflict with and stand as an obstacle to achievement of the full objectives and purposes of Federal labeling requirements for pharmaceutical and biologic products.   The FDA explains that it makes labeling decisions based on “a comprehensive scientific evaluation of the products’s risks and benefits under the conditions of the use prescribed, recommended, or suggested in the labeling.”   The FDA further explains:

Given the comprehensiveness of FDA regulation of drug safety, effectiveness, and labeling under the act, additional requirements for the disclosure of risk information are not necessarily more protective of patients.   Instead, they can erode and disrupt the careful and truthful representation of benefits and risks that prescribers need to make appropriate judgments about drug use. Exaggeration of risk could discourage appropriate use of a beneficial drug.

* * *

State law actions also threaten FDA’s statutorily prescribed role as the expert Federal agency responsible for evaluating and regulating drugs. State actions are not characterized by centralized expert evaluation of drug regulatory issues. Instead, they encourage, and in fact require, lay judges and juries to second-guess the assessment of benefits versus risks of a specific drug to the general public – the central role of FDA – sometimes on behalf of a single individual or group of individuals. That individualized reevaluation of the benefits and risks of a product can result in relief – including the great of significant damage awards or penalties – that creates pressure on manufacturers to attempt to add warnings that FDA has neither approved nor found to be scientifically required. This could encourage manufacturers to propose “defensive labeling” to avoid State liability, which, if implemented, could result in scientifically unsubstantiated warnings and underutilization of beneficial treatments.

Id., at 3935.   The FDA’s full analysis can be read in the following link, under section “D” entitled “Comments on Product Liability Implications of the Proposed Rule,” at p. 37).


Since promulgating this Final Rule in January, 2006, there has been considerable debate in the courts as to the level of deference courts should give to FDA’s position regarding preemption.   This issue was recently the focus of pre-trial motions in two cases pending in the Vioxx multidistrict litigation pending in New Orleans, Louisiana, In Re: Vioxx Products Liability Litigation, MDL No. 1657, United States District Court, Eastern District of Louisiana.   In a July 3, 2007 ruling, the Court rejected Merck’s preemption defense and concluded that “the FDA’s current view on the question of immunity for prescription drug manufacturers is entirely unpersuasive and thus not entitled to deference.” A copy of the July 3, 2007 Order and Reasons is attached in the following link.   Order

In the Vioxx MDL, Merck filed motions for summary judgment in two of the pending cases on the grounds that the plaintiffs’failure to warn claims were impliedly preempted because the Vioxx labeling was approved by the FDA. The label expressly mentioned the results of a study that showed a statistically significant increase in serious cardiovascular thrombotic events and noted that such information “should be taken into consideration and caution should be exercised when Vioxx is used in patients with a medical history of ischemic heart disease.” In both of the cases, the plaintiff did not begin taking Vioxx until after Merck had revised, and the FDA had approved, the package insert warning of the risk of cardiovascular thrombotic events.

In reaching its ruling, the Vioxx Court noted that several other courts have given deference to the FDA’s position and recognized implied preemption, but concluded that “the majority of courts continue to find that state-law claims against prescription drug manufacturers are not preempted, affording little or no deference to the FDA’s recent statements.”   See, Order and Reasons, at p. 16, for the Court’s listing of opinions for and against giving deference to the FDA’s position.   The Court discussed several reasons for refusing to give deference to the FDA, including: (1) the preemption statements in the preamble “were not promulgated pursuant to [FDA’s] rulemaking authority, nor do they seek to clarify any ambiguity in the FDA regulations …, [r]ather, the FDA added these views at the end of the rulemaking process in a preamble….” (2) prior to January 24, 2006, the FDA had recognized that state-law claims could coexist with federal regulation of prescription drugs; and (3) because there are no federal remedies for individuals harmed by prescription drugs, a finding of implied preemption “… would abolish state-law remedies and would, in effect, render legally impotent those who sustain injuries from defective prescription drugs.”

Although not discussed as one of the formal bases for its ruling, the Court made a point to state its concern that “FDA must rely heavily, if not exclusively, on the data provided by the manufacturer, the very entity that seeks approval of the drug and its label.”  The Court noted that “while the scope of the FDA’s duty is vast, it is increasingly argued that the agency’s staffing, laboratory facilities, and research capacity is sorely lacking; calls for changes in the FDA’s structure and procedures have only increased in the wake of Merck’s voluntary withdrawal of Vioxx from the market.”   Order and Reasons,  pp. 10-11.   It is unclear to what extent these latter concerns factored in the Court’s preemption analysis, but it is significant that the Court chose to mention them in the ruling.

The Vioxx Court’s ruling is the first in Louisiana addressing the effects of FDA’s 2006 preamble statements, and it certainly will add fuel to the debate over the deference that should be given FDA’s preemption statement. Several other courts have thoroughly considered the issue and have ruled that FDA’s statement is entitled to great deference.   See, e.g., Sykes v. Glaxo-SmithKline, 484 F.Supp.2d 289, 306-17 (E.D. Pa. 2007) and In re Bextra & Celebrex Mktg. Sales Practices & Prod. Liab. Litig., MDL 1699, 2006 WL 2374742, at *5-12 (N.D. Cal. Aug. 16, 2006).   Those courts note, among other things, that “… an agency’s view of the preemptive effect of its regulations may change over time as the agency gains more experience with the interrelationship between its regulations and state laws.” See In re Bextra, supra, at *8. They further recognize that the FDA is not constrained to express its preemption position in formal rule-making procedures, but rather may “communicate those intentions, for example, through statements in regulations, preambles, interpretive statements, and responses to comments.” Sykes, supra, 484 F.Supp.2d at 314, quoting Horn v. Thoratec Corporation, 376 F.3d 163, 170 n. 12 (3rd Cir. 2004).

Merck has requested the United States Fifth Circuit Court of Appeal to address the issue, but it remains to be seen whether the Fifth Circuit will intervene at this juncture. Until the issue is addressed more thoroughly at the appellate levels, it appears that the viability of the preemption defense will continue to be difficult to predict and likely will vary from jurisdiction to jurisdiction.