FDA’s Rule Pre-empting State Law Failure-to-Warn Claim is Rejected

On July 3rd, the Vioxx multidistrict litigation court held that the Food and Drug Administrations (FDA)’s rule preempting state products liability law suits against drug companies in failure-to-warn claims is not persuasive. The court also stated that FDA cannot assume that Congress intended to override the long-standing presumption against preempting state law.

The court’s ruling is a victory for consumers injured by medicines that they claim are inaccurately labeled. Though issued in litigation pertaining to Vioxx, the ruling may also end up being applied to Avandia as cases are brought and move forward.

The FDA’s preemption theory is found in the preamble of its final regulations issued on January 4th, 2006, which states that products liability failure-to-warn claims based on drug labeling are preempted.

Eldon E. Fallon, U.S. judge of the Eastern District of Lousiana, in denying summary judgment on the basis of preemption, stated that the FDA’s preamble is only an opinion about plaintiff’s state law claims and the viability of such claims. According to Judge Fallon, “[The Preamble] does not purport to interpret any specific or regulatory provision, nor is it a regulation itself.” The court concluded that the preamble can only persuade but it lacks the power to regulate.

Judge Fallon also rejected the FDA’s argument of implied preemption. The FDA regulations, unlike state laws,do not provide any remedies for those who have been harmed by prescription drugs. Inasmuch as finding implied preemption would render the remedies prescribed by state laws useless,those who have been injured due to prescribed medicines that are found to be defective would thus have no means of legal recourse.

Although the court concluded that there exists no conflict between federal law and the state-law claims of plaintiffs, there are still issues about the FDA’s shortcomings regarding the safety of prescription drugs. In March of 2006, the General Accounting Office (GAO), in its report titled “Improvement Needed in FDA’s Post-market Decision-making and Oversight Process”, concluded that the “FDA lacks clear and effective processes for making decisions about, and providing management oversight of, post-market safety issues.

“The process has been limited by a lack of clarity about how decisions are made and about organizational roles, insufficient oversight by management, and data constraints.”

In agreement, the FDA responded that the conclusions of the GAO were reasonable. The FDA requested that the The National Academies’ Institute of Medicine prepare a report regarding the country’s drug safety system. The Institute of Medicine reported that the system is ineffective because of “serious resource constraints that weaken the quality and quantity of science that is brought to bar on drug safety; an organizational culture in [FDA] that is not optimally functional.”

Even employees of the FDA are uncomfortable with the FDA’s policies and practices regarding the approval of new drugs. In a survey conducted by the Union of Concerned Scientists last July, sixty percent of the FDA employees surveyed stated that they were aware of situations “where commercial interests have inappropriately induced or attempted to induce the reversal, withdrawal or modification of FDA determinations or actions.” The survey also showed that 18 percent of those surveyed stated that they “have been asked, for non-scientific reasons, to inappropriately exclude or alter technical information or [their] conclusions in an FDA scientific document.”

A survey conducted by the Department of Health and Human Services revealed that 18 percent of the FDA’s scientists and physicians who were surveyed felt that they were pressured to recommend that medications should be approved although they felt concerns regarding the quality, effectiveness, and/or safety of such medications. The personal injury lawyers at Levine & Slavit have decades of experience in handling personal injury claims involving dangerous and defective products . If you or someone close to you has been injured by a drug that was not properly labeled, contact the offices of Levine & Slavit in for their help. Levine & Slavit has offices in Manhattan and Long Island, handling cases in New York City, the Bronx, Brooklyn, Queens and surrounding areas including Westchester County.

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