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Drug manufacturers win pre-emption appeal

LOUISIANA RECORD

Thursday, November 21, 2024

Drug manufacturers win pre-emption appeal

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NEW ORLEANS – The U.S. Court of Appeals for the Fifth Circuit has upheld a lower court’s dismissal of a case brought by a Louisiana couple against the makers of the heartburn drug Reglan

Penny and John Morris originally sued PLIVA Inc., TEVA  Pharmaceuticals USA Inc. and Actavis Elizabeth LLC claiming that Penny Morris had been injured by using the pharmaceutical metoclopramide, or brand name Reglan.

Morris took the drug from early 2006 until July 2008. She allegedly developed movement disorders as a result of taking metoclopramide.

The district court dismissed the suit finding the Morris’s claim of inadequate warning was preempted.

In a per curiam opinion Circuit Judges W. Eugene Davis, Edith Jones and Jerry E. Smith held that the plaintiffs' failure to warn claims fail because the information (that Reglan could be dangerous) was available as early as 2003 in the FDA’s “Orange Book.”

The case is one of many resulting from injuries caused by Reglan and is controlled by PLIVA, Inc. v. Mensing which, according to the court, held that state law claims against generic manufacturers of Reglan were preempted by FDA regulations.

The panel upheld the dismissal of the suit.

Case No. 12-3019.

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