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Diet Drug Litigation – Fen-Phen

It seemed like a miracle cure to many Americans battling obesity. “Fen-phen” — a combination of the two diet drugs fenfluramine and phentermine — was achieving great success in treating obesity. Both fenfluramine and phentermine had been approved by the U.S. Food and Drug Administration (FDA). However, the use of the drugs in combination had not been FDA-approved and was being used “off-label.” When it was determined that fenfluramine was linked to heart-valve damage, manufacturers voluntarily removed the drug fenfluramine from the market upon recommendation to do so by the FDA. Phentermine is still on the market as there have been no studies linking that drug to heart valve damage. The FDA recommended that patients who took the combination fen-phen consult their physicians about having an echocardiogram to determine whether heart valve damages has occurred.

As a result of the drug recall, thousands of lawsuits have been filed against American Home Products (AHP), the company responsible for the marketing, sale and labeling of fenfluramine in the United States. More than 100 class action suits were also filed against the company seeking:

  1. to create an equitable fund to provide medical screening services to patients who had used fenfluramine for varying periods of time to determine if they had asymptomatic valvular heart disease;

  2. to recover the amounts expended by consumers to purchase the drug or to obtain echocardiograms as a consequence of exposure to these drugs; and

  3. to recover personal injury damages on behalf of classes of persons who took the drug.

The Judicial Panel on Multidistrict Litigation coordinated and consolidated all the cases filed in federal court to one court. The court determined that there were up to 6 million class members. In 1999, a preliminary settlement was entered into between AHP and the federal class. At that time, all people who took fenfluramine made, manufactured, or marketed by AHP were given notice of the settlement, their settlement rights, and how they could receive benefits under the settlement. All of these people were considered members of the class action and had to “opt out” of the class by affirmatively communicating the wish not to be a member of the class. In 2002, the United States District Court for the Eastern District of Pennsylvania granted a final approval of a settlement of the consolidated federal fen-phen cases. The settlement provides refunds for the costs of purchasing the drug, medical monitoring and some medical treatment or payment for monitoring and treatment, and compensation for some valvular heart conditions that are evaluated under specific conditions and meet certain medical requirements.

Payments to class members come out of a trust established by AHP. The trust calculates the benefits of each class member separately, depending on each member’s individual damages. In order to recover under the trust, class members were required to register with the trust by August 1, 2002 for certain benefits and by May 3, 2003 for other benefits. Those who opted out of the class action may pursue independent actions against AHP.

Copyright 2011 LexisNexis, a division of Reed Elsevier Inc.


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