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The Food and Drug Administration may only be blowing smoke by prefacing a new drug-labeling rule with a purported pre-emption of state court suits against drug makers, but it’s gotten some lawyers hopped up and others steamed. The source of the venting is a wordy preface to “Requirements on Content and Format of Labeling Human Prescription Drug and Biological Products” in the Code of Federal Regulations. The preamble took lawyers by surprise because it was not included in the proposed rule as published for comment. It says that “under existing pre-emption principles, FDA approval of labeling under the act. . . pre-empts conflicting or contrary state law” and goes on to list claims that are pre-empted, including failure to warn based on omission of labeling information. Immediately after the final rule — with preamble — was published on Jan. 18, plaintiffs lawyers and consumer activists excoriated the FDA for exceeding its authority. Across the aisle, lawyers for drug makers saw the preamble as a bulwark for bolstering their clients’ defenses. “This is big,” says John Brenner, of Newark, N.J.’s McCarter & English, who represents Pfizer, Eli Lilly & Co., and Bristol-Myers Squibb Co., among others. “It opens a whole new front in pharmaceutical products-liability litigation that most people thought was moot. Now it becomes an issue in almost every case.” Although Brenner expects some courts to resist the notion that the FDA is the final arbiter in prescription-drug liability cases, he expects circuit courts to split on the issue, sending the case to the U.S. Supreme Court in five or six years. “In the meantime there will be pitched battles all over the country,” he says. “This is obviously a new, more powerful statement of FDA’s position,” says Scott Elder of Alston & Bird’s Atlanta office, who defends drug makers. Another lawyer for drug makers, Paul Kim of Foley Hoag in Washington, says of the preamble, “It’s more of a clarification than anything truly novel. What’s new is the manner in which FDA has done it.” Specifically, the FDA bypassed the public notice and comment provisions of the Administrative Procedure Act. James O’Reilly, former FDA chief counsel and now a University of Cincinnati law professor, says the preamble is nothing more than a nonbinding advisory opinion. “It won’t be persuasive to the courts,” he says. When the FDA issued its proposed rule on Dec. 22, 2000, it stated that it had found no policies in the rule that had federalism implications or that pre-empted state law. “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 pre-empt state law,” the FDA stated. Steven Rauschenberger, an Illinois state senator and the president of the National Conference of State Legislatures, charges the agency with taking a backdoor approach. “FDA seeks to insert this currently unavailable language into its final rule without going through the requisite comment period that should be accorded to such an important shift in agency position,” he says. “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 has asked Health and Human Services Secretary Michael Leavitt to withdraw the language or republish the labeling rule to allow public comment on the controversial provision. Ken Suggs, president of the Association of Trial Lawyers of America, likewise condemns the FDA’s stealth approach to announcing a major policy shift on pre-empting state drug liability laws. “Congress has not given the FDA the statutory authority to promulgate rules pre-empting state tort law in this area,” he says. “Inserting language in the final rule counter to the proposed language is highly unusual and deprives organizations and individuals [of] their right to comment in the rule-making process.” Daniel Troy, who was the FDA’s chief counsel during the rulemaking process, says the preamble is the agency’s response to drug makers’ concerns over liability if certain risks and warnings are omitted. The labeling rule requires drug makers to include a “highlights” section with dosing information, product benefits and risks, and a section for boxed warnings. “Many of the comments we got on the proposed labeling rule said, �The highlights are all well and good but not if you expose us to potential state court liability for failure to warn,’ ” says Troy, who now represents drug companies with Sidley Austin Brown & Wood in Washington. So the preamble was worded to tell plaintiffs not to sue in state courts, based on the premise that the FDA has sole jurisdiction over prescription-drug companies’ labeling procedures. “I hope and expect the courts will accord FDA deference as a matter of federal law,” he says. But in the three years since Troy first made the pre-emption argument, in a friend-of-the-court brief on behalf of drug company Pfizer in a suit over suicide-related risks of the drug Zoloft, reaction has been tepid. The company has fended off some suits, but U.S. Chief District Judge James Rosenbaum in Minneapolis rejected the pre-emption theory out of hand, calling it “perverse” and a “public policy argument gone awry.” If the new rule’s preamble is to have an effect, the most immediate could be on the 9,200 suits against Merck & Co. Inc. over its painkiller Vioxx, most of which allege a failure to warn. “This issue is going to give Merck another significant tool for its Vioxx tool box,” says Jane Thorpe, of Foley Hoag in Washington.
Lisa Brennan is a reporter for the New Jersey Law Journal , the ALM publication in which this article first appeared.

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