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February 4, 2008

Teflon Paste Failure-to-Warn Claim Preempted by Medical Device Amendments

In yet another case, a court has ruled that a failure to warn claim regarding a Class III medical device is preempted by the FDA's approval of the product for sale.  In Mathis v. E.I. dupont De Nemours & Co., W.D. La., No. 06-0825 (1/16/08), the plaintiff claimed that she was injured by a Teflon paste used to treat her vocal chords paralyzed because of earlier thyroid surgery.  The product manufacturer moved for summary judgment arguing that Mathis' failure to warn claim was preempted.  In granting the defendant's motion, the court noted that the FDA had imposed device-specific requirements on the product, including requirements for the information to be included in the product's labeling and warnings, and that the warnings could not be modified without FDA approval.  To say that the warnings were inadequate or that additional or different warnings were required under state law would be imposing state requirements "different from or in addition to" those imposed by the FDA and thus, the court concluded, were preempted under 21 U.S.C. section 360k(a) of the Medical Device Amendments to the Food, Drug & Cosmetics Act.


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