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ARTICLE · 04 AUGUST 2006

FDA Approval of Pharmaceutical Labeling Preempts Warning Claims

In a Chadbourne & Parke LLP Client Alert issued earlier this year,we reported that the FDA had issued revised regulations governing prescription drug labeling requirements generally preempting state laws. Since then, the issue has come to decision in at least two cases favoring pharmaceutical interests -- "Abramowitz and Colacicco".

United StatesLitigation, Mediation & Arbitration
Robert Conrad
Robert Conrad
David Wallace
David Wallace

See

Abramowitz v. Cephalon, Inc., 2006 WL 560639 (N.J. Super Ct., March 3, 2006); Colacicco v. Apotex, Inc., 2006 WL 1443357 (E.D. Pa.,May 25, 2006).

In a Chadbourne & Parke LLP Client Alert issued earlier this year,we reported that the FDA had issued revised regulations governing prescription drug labeling requirements generally preempting state laws.1 Since then, the issue has come to decision in at least two cases favoring pharmaceutical interests -- Abramowitz and Colacicco.

Actiq

Abramowitz

appears to have been one of the first reported decisions addressing the preemptive effect of these regulations. It involved allegations that Cephalon -- the maker of a pain medication called Actiq -- had failed to warn plaintiff that use of the drug, which contains sugars used to mask the unpleasant taste of the Fentanyl it contains,was associated with tooth decay.

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