Battle Brews Over New FDA Rule Preempting State Law

A quite battle appears to be brewing between the courts and prescription drug regulators in the Bush administration.

On Jan. 18, the Food and Drug Administration announced its final rule on new federal requirements for drug warning labels, Requirements on Content and Format of Labeling Human Prescription Drug and Biological Products, 21, C.F.R., Parts 201,314, 601. The action had been in the works for five years. Under the guise of helping consumers by making the instruction sheets that accompany prescriptions more user friendly, the preamble to the final rule contains some controversial language.

The requirements state that they preempt all state tort liability claims based on inadequate drug warning labels. It’s not clear where the FDA finds the authority to alter the current state of law. In fact, in its Notice of Proposed Rule-Making issued Dec. 22, 2000, the FDA stated, "Because enforcement of these labeling provisions is a federal responsibility, there should be little, if any, impact from this rule, if finalized, on the states or on the distribution of power and responsibilities among the various levels of government. In addition, this proposed rule does not preempt state law." Fed. Reg. Vol. 65, No. 247.

State Sen. Steven Rauschenberger, R-Elgin, the President of the National Conference of State Legislatures, has said, "It is unacceptable that FDA would not permit the states to be heard on language that has a direct impact on state civil justice systems nationwide." Rauschenberger wants the language withdrawn or the labeling rule republished to allow public comment on the controversial provisions.

In essence, without any opportunity for public reaction, and in apparent violation of the provisions of the Administrative Procedure act, the FDA issued a final rule that may have significant implications in failure-to-warn cases. These include most of the 9,200 suits against Merck & Co. Inc. over its Vioxx painkiller.

A court case now underway in Chicago sheds light on the law surrounding this preemption controversy.

Donald Zikis died Dec. 16, 2002. He killed himself, allegedly as a result of taking the prescription drug Zoloft. His widow brought a lawsuit against the pharmaceutical company, Pfizer, claiming a failure to properly warn users of the drug’s dangerous side effects. Zikis v. Pfizer, N.D. Ill., No. 04 C 8104, decided Nov. 8, 2005.

The drug manufacture contended that the plaintiff’s claims were preempted by the Food, Drug and Cosmetic Act (FDCA), 21, U.S.C.S. sect. 301 et seq. Specifically, Pfizer argued that at the time Zikis took the product, the association between suicide and Zoloft was unknown.

U.S. District Judge Samuel Der-Yeghiayan was unpersuaded even by an amicus brief filed by the FDA. He found that "although Congress may not have impliedly ‘occupied the field’ in a certain area, ‘state law is naturally preempted to the extent of any conflict with a federal statute’ that either (1) makes it ‘impossible for a private party to comply with both state and federal laws,’ or (2) makes the state law an obstacle to the accomplishment and execution of the full purposes and objectives of Congress." Id., [citations omitted].

In the Zikis case, the court found that the manufacturer failed to show any tangible conflicts between the widow’s claims and the FDCA. In fact, the court held that Pfizer could have unilaterally supplemented its warning label as soon as the increased suicide risk was discovered, as provided by FDA regulations.

In rejecting the defendant’s motion for reconsideration of the court’s denial of its motion for summary judgment, the court rejected Pfizer’s argument that added warnings to the label "might mislead physicians about the risks entailed in prescribing a drug, ‘thereby overdeterring its use.’" Id. Instead, as the court in Zikis pointed out, a drug manufacturer can, "without prior approval by the FDA, add warnings that ‘add or strengthen a contraindiction, warning, precaution, or adverse reaction.’" Id. That approach certainly embraces the very mission of the FDA, which is to protect the public’s health.

As of this writing, the Zikis case was in settlement talks and could settle in February.

Perhaps the new FDA rule should be challenged. If the U.S. Supreme Court were to follow its reasoning in Medtronic v. Lohr, 518 U.S. 470 (1996), in which it upheld state tort law claims against a medical device manufacturer, the FDA’s latest actions on warning labels may well be found constitutional. The defendants in Zikis have not demonstrated that Congress meant to eliminate judicial recourse for those injured by negligent conduct.

Interestingly, James O’Reilly, who teaches food and drug law at the University of Cincinnati College of Law, has been quoted as saying that the preamble is nothing more than a non-binding advisory opinion and will not be persuasive to the courts.

The new rule will not take effect until June 30. Before that time, regardless of any recourse in the courts, lawyers and consumers have time to contact their congressional representatives to question the FDA’s action. Doctors, too, should be concerned about how these new regulations impact them, particularly since their input also was not sought.