The new prescription drug labeling rule from the Food and Drug Administration asserts that if a label meets the agency’s requirements, state law failure-to-warn suits over the drug’s risks are preempted.

And experts predict courts are likely to defer to this position and find drug makers’ warnings to be sufficient if they meet the FDA’s requirements.

The rule “clearly bolsters a defendant’s argument that a warning [is adequate if it] complied with FDA oversight and review,” said Victor Schwartz, general counsel for the American Tort Reform Association in Washington, D.C, and a partner at Shook, Hardy & Bacon. “I think any judge in America who has the slightest bit of balance would give preemptive effect to this rule.”

Daniel Troy, former chief counsel of the FDA and a partner with Sidley Austin Brown & Wood in Washington, D.C., agreed.

“If any court applies sound administrative law principles, it should find this is entitled to deference,” he said.

The rule states that the “FDA believes that under existing preemption principles, FDA approval of labeling under [federal law], whether it be in the old or new format, preempts conflicting or contrary state law.”

But plaintiffs’ attorneys say that the FDA’s action is another attempt by the Bush administration to inappropriately slide tort reform into federal regulations.

“This is totally unsupportable in the case law and by the factual history of FDA’s traditional role,”said Los Angeles plaintiffs’ attorney Karen Barth Menzies, who has fought the FDA on this issue for years.

Philadelphia plaintiffs’ lawyer Thomas R. Kline, who practices with Kline & Specter, agreed.

“The FDA has gratuitously added commentary in the rule’s preamble, which has no force and effect of law,” he said, predicting that courts would strike it down.

The National Conference of State Legislatures has stated its opposition, complaining that the FDA should have consulted with the states before issuing such a policy statement.

Barth Menzies, who practices with Baum Hedlund, said that she and others are working with members of Congress to try to get the language removed from the rule.

In the interim, however, the FDA’s position is likely to have a big effect on the thousands of Vioxx claims waiting to be tried.

“It’s inevitable that … Merck … [is] going to raise preemption and cite the FDA’s language in the preamble,” said Kline, who serves on the plaintiffs’ steering committee for the Vioxx multi-district litigation.

Controversial Preamble

In general, the rule is intended to make package inserts in prescription drugs easier to read and understand.

The rule creates new “highlights” and “table of contents” sections to make clearer the major benefits and risks of a drug.

The label must also include the date the product was approved by the FDA, in addition to contact information to encourage the reporting of adverse events and side effects.

However, for product liability lawyers the most important part of the rule is contained in 10 pages of its preamble, where the FDA outlines its position that compliance with its rules on prescription drug package warnings would bar state law claims over the warnings.

“Under [federal law], FDA is the expert federal public health agency charged by Congress with ensuring that drugs are safe and effective, and that their labeling adequately informs users of the risks and benefits of the product and is truthful and not misleading,” the rule says.

The agency claims that state law product liability suits “threaten” its ability to disseminate information about scientifically substantiated risks of drugs without “overwarning” consumers to the point that they don’t heed to the most essential risk statements.

“The FDA interprets [federal law] to establish both a ‘floor’ and a ‘ceiling,’ such that additional disclosures of risk information can expose a manufacturer to liability … if the additional statement is unsubstantiated or otherwise false or misleading,” the rule states.

It goes on to list a number of specific failure-to-warn claims the FDA believes would be preempted. For example, the rule would preempt a claim that a drug maker failed to include warnings in the label that aren’t required by the agency.

A claim based on a drug maker’s failure to include certain labeling information in direct-to-consumer advertising would also be preempted, as long as the drug maker included a “brief summary” of the label as mandated by the rule.

Ongoing Debate

The FDA’s position is nothing new.

The rule itself states that the agency has made similar preemption statements in rules since 1982, including those related to aspirin labeling, over-the-counter drug packaging and drug warnings about pregnancy and nursing.

Since 2001, the FDA has been asserting in amicus briefs that its opinions preempt state tort law, in particular weighing in on suits over anti-depressants and suicide. The agency has argued that when it began approving certain anti-depressants, it made a determination that it wasn’t going to require specific warnings about suicide, and therefore any more stringent warnings that might have been required by state law should be preempted.

Throughout this time, plaintiffs’ lawyers have openly disagreed with the FDA. They claim that the agency provides only a minimum standard and that states have the right to impose stricter rules for drug warnings.

“The role of the FDA is to approve medications with the most accurate label based on what it knows at the time,” said Barth Menzies. “But it’s within the state court’s realm to police public health matters. If they want to require safer or stronger methods, they are allowed to do so. That doesn’t mean the federal standards conflict with the state ones.”

Furthermore, even if a company complied with the FDA’s requirements for a drug package insert, “a failure-to-warn claim goes far beyond the label,” Barth Menzies argued.

For example, “the company might have included the warning in the label, but neutralized in the way it spoke to physicians about the drug or in any promotional materials,” she contended.

Troy claims that the rule still leaves open the option to bring other types of suits.

“The only thing this even purports to address is failure-to-warn claims,” he said.

Schwartz agreed that “this doesn’t protect a company against fraud” or breach of warranty claims.

But Barth Menzies contended that the matter isn’t that simple, because private citizens can’t bring “fraud on the FDA” claims arguing that a drug maker failed to provide information it knew about a drug’s risks to the FDA.

And Kline argued that the potential viability of claims other than failure-to-warn skirts the real issue.

“The heart of drug litigation focuses on the failure-to-warn claim,” he said. “While there might be breach of warranty claims that would remain, this could strike a dagger in the heart of prescription drug product liability litigation.”

The rule goes into effect on June 30.

You can read or print the full text in the “important documents” section of the New England In-House website at www.newenglandbizlawupdate.com.

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