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August 12, 2008

Texas Plaintiffs' Claims Preempted by Buckman

The judge overseeing multidistrict litigation regarding the bone-building drugs Aredia and Zometa dismissed plaintiffs' claims finding that a Texas law shields manufacturers of Food & Drug Administration-approved drugs from liability for failure to warn. In re:  Aredia and Zometa Products Liability Litigation, M.D. Texas, No. 06-1760, 7/25/08.  A separate provision of the Texas shield law provides that a plaintiff may rebut the presumption of non-liability by showing that the defendant withheld from or misrepresented to the FDA, the required information that was material to the drug's performance and was causally related to the plaintiff's injury.  The Texas law's rebuttal standard, however, amounts to a "fraud on the FDA" claim of the kind that is preempted by federal law for the reasons expressed in the U.S. Supreme Court's ruling in Buckman v. Plaintiffs' Legal Committee, 121 S.Ct. 1012 (2001).

JDP

August 12, 2008 | Permalink

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