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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