Another Federal Court Finds Fraud-On-The-FDA Claims Preempted

What Happened?

Another federal district court ruled that the United

States Supreme Court's ruling in Buckman v. Plaintiffs'

Legal Committee is precedential in finding preemption of

failure to warn claims based on withholding information or

misrepresenting information to FDA.

What Does It Mean?

The majority of courts to address the viability of

failure-to-warn claims based on this type of fraud-on-the-FDA

theory have ruled that these claims are preempted.

"Buckman preemption" is an important defense to

failure-to-warn claims under state immunity statutes containing

fraud-on-the-FDA exceptions.

State tort reform efforts of the last few years led several

states to enact legislation providing immunity or rebuttable

presumptions to prescription drug and medical device manufacturers

facing failure to warn claims ? i.e., claims

that the labeling submitted to and approved by FDA on the basis of

safety and efficacy did not adequately warn physicians of a

particular side effect. Many of these statutes contain exceptions

or allow plaintiffs to rebut the presumption by proving

fraud-on-the-FDA ? that the manufacturer withheld or

misrepresented information from FDA. Manufacturers have wisely

challenged failure-to-warn claims brought under these statutes on

the grounds that they are preempted by federal law and FDA

regulations in accordance with the United States Supreme

Court's decision in Buckman v. Plaintiffs' Legal

Committee. In Buckman, the U.S. Supreme Court ruled

that federal law ? specifically, the Food, Drug and

Cosmetic Act (FDCA) ? preempted claims arising from a

manufacturer's alleged fraud-on-the- FDA.

A number of courts have been faced with the issue of whether,

under Buckman, the FDCA and FDA regulations preempt

failure to warn claims relying on these fraud-on-the-FDA

provisions. The majority of courts confronted with the issue have

ruled that these claims are indeed preempted. The issue reached the

United States Supreme Court earlier this year in Warner-Lambert

Company v. Kent but the Court split 4-4 ? leaving

its decision devoid of precedential authority.

In July 2008, subsequent to Kent, in In re Aredia

and Zometa Products Liability Litigation, 2008 WL 2944910

(M.D. Tenn. July 25, 2008), another federal court ruled that

Buckman preempts plaintiffs' failure-to-warn claims

based on a fraud-on-the-FDA exception to Texas' product

liability statute. Aredia involved failure-to-warn claims

brought by patients allegedly injured by Aredia and...

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