FDAnews Drug Daily Bulletin


Jan. 18, 2005

Wyeth has agreed to support an amendment to a nationwide legal settlement with users of its fen-phen products -- a move that would guarantee payments to the largest group of members involved in the class action lawsuit.

The so-called seventh amendment to the National Diet Drug Settlement calls for the creation of a new claims processing structure, funding arrangement and payment schedule for matrix Level I or II claims, the least serious but most numerous claims in the settlement. The settlement involves claims filed against Wyeth by users of Pondium (fenfluramine) and Redux (dexphenfluramine), two Wyeth drugs used in the popular fen-phen diet treatment. The drugs were recalled in 1997 after research showed they might cause heart-valve damage and a fatal lung condition.

Under the terms of the amendment, all qualified Level I and II claimants would receive a pro rata share of a new $1.275 billion settlement fund to be created by Wyeth. Class members who have more serious claims (Level III and IV) are not affected by the amendment.

The amendment was approved on a preliminary basis by the U.S. District Court for the Eastern District of Pennsylvania in August 2004, but it had to be approved by the majority of the claimants before it could be finalized.

Wyeth's decision to support the changes clears the way for the amendment to be formally approved by the court, which has scheduled a Jan. 18 hearing to address the matter.