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FDAs New Labeling Rule Adds Fuel to Preemption Fire

By Teresa Rider Bult, Litigation News Associate Editor – November 26, 2008

While some consider the FDA‘s new rule [PDF] “clarifying” its supplemental application for drug and medical device labeling as tightening the process for changing labels, the plaintiffs’ bar has expressed concern that the rule [PDF] will assist in shielding companies from failure to warn liability.

FDA Approval of Labels
The FDA requires that drug, biologics, and medical device manufacturers obtain FDA approval of their warning labels before the drugs or devices are marketed and sold. Manufacturers generally must also obtain FDA approval before making changesto labeling information. However, in limited circumstances, companies can revise or supplement their warning labels prior to FDA approval (through changes being effected (CBE) supplements) to ensure consumers are immediately made aware of newly discovered risks.

The labeling regulations [PDF], which became effective in late September, clarify that a manufacturer can make unilateral pre-FDA approved labeling changes “only to reflect newly acquired information” when there is “reasonable evidence of a causal association” between the drug or device and the risk.

The final rule defines “newly acquired information” as “information not previously submitted to [the] FDA.” This includes “new analyses of previously submitted data,” such as adverse event reports, new clinical study information, and new analyses that “reveal risks of a different type or greater severity or frequency than previously included in submissions to [the] FDA,” the Federal Register notes.

History of the Rule
Until the rule was enacted, there was room for interpretation as to whether a manufacturer was allowed, or, conversely, had the duty, to revise its warning labels prior to FDA approval. Plaintiffs would often argue that under various state product liability laws, the manufacturers had a duty to unilaterally revise their warning labels prior to (or sometimes despite) FDA approval, and that the company’s inadequate warning resulted in their injury.

In the rulemaking process, the FDA declined requests to set “different standards for when a sponsor must warn, as opposed to when it may warn of a particular risk or adverse event.” The FDA also disagreed with comments that the rule would undermine confidence in medical products. The rule is “intended to ensure that scientifically valid and appropriately worded warnings will be provided in the approved labeling for medical products, and to prevent overwarning, which may deter appropriate use of medical products, or overshadow more important warnings,” the FDA notes.

“This change strengthens the agency’s ability to fulfill its role of protecting the public health,” says Neville Boschert, Jackson, MS, Section of Litigation Products Liability Committee’s Medical Device subcommitee cochair.

“The rule does not relieve a sponsor of its duty to maintain its label, but clarifies the FDA’s position of what constitutes sufficient evidence to meet the standards required for a label change,” Boschert says.

Opposition to the Rule
Some members of the plaintiff’s bar disagree. “The rule allows drug and device companies to claim complete immunity for failing to warn,” says American Association for Justice President Les Weisbrod, Washington, D.C., in a recent press release.

“Between the drug companies ghostwriting medical journal articles and misrepresenting data to the FDA in order to meet regulations, the agency’s action with this rule leaves many people and their doctors in the dark without information about the hazardous side effects of prescription drugs and medical devices,” Weisbrod says.

Effect on State Tort Law
Plaintiffs are also concerned the new rule will strengthen arguments that FDA regulations preempt state tort law. Discussing the new rule, the FDA asserts that when a product manufacturer does “not meet the standard to change its labeling through a CBE supplement under this rule to include the warning a plaintiff alleges should have been added to labeling, [s]tate law liability that is premised on a failure to warn is preempted.”

The agency also states that “an ‘irreconcilable conflict’ (i.e., an impossibility of compliance with both [f]ederal and [s]tate law) is not the only basis for preemption of [s]tate law. Under implied preemption principles, if a [s]tate law frustrates [f]ederal objectives, the [s]tate law is preempted.”  Even so, the FDA makes clear, “This rule does not preempt all [s]tate tort law.”

The FDA’s position on preemption is consistent with its prior stance, which has caused controversy for years, says Lori B. Leskin, New York, cochair of the Section’s Products Liability Committee Pharmaceuticals Subcommittee.

Supreme Court Review
This controversy has culminated in the closely watched U.S. Supreme Court case of Wyeth v. Diane Levine [PDF], set to be heard on November 3, 2008, Leskin notes. 

“The FDA CBE amendment and the Levine case must be analyzed hand-in-hand,” Leskin says. “It is the expectation that the Levine case will ultimately decide this precise issue—whether the FDA’s authority to approve drug labeling preempts state laws governing products liability, for CBE cases and otherwise,” Leskin notes.

Although it is too soon to tell how this controversy will be resolved, guidance is on the horizon, Leskin predicts.


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