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Fen-Phen Litigation Against American Home Products Corporation: The Widespread Use of Fenfluramine (Pondimin) and Dexfenfluramine (Redux) for Weight Loss, The Health Problems Associated with Those Drugs, the Resulting Litigation Against American Home Prod

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2000

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Fen-Phen Litigation Against American Home Products Corporation: The Widespread Use of Fenfluramine (Pondimin) and Dexfenfluramine (Redux) for Weight Loss, The Health Problems Associated with Those Drugs, the Resulting Litigation Against American Home Prod (2000 Third Year Paper)

Abstract

The fen-phen affair has spawned thousands of lawsuits and a multitude of scientific studies concerning valvular heart disease. It has also led to a lively debate over off-label prescriptions, medical monitoring, and class actions. The proposed Settlement Agreement, while an attempt to put an end to the valvular litigation, will not be the end of the fen-phen affair. The Settlement Agreement has been widely criticized and plaintiffs' lawyers have indicated that there will be a large number of opt-outs, which could lead to a termination of the Agreement by American Home Products. In addition, PPH claims are generally not settled by the Agreement and plaintiffs are free to pursue those claims in court. American Home Products may be facing liability for fen-phen for years to come, and there is still much to be learned about the valvular heart disease associated with Redux and Pondimin use. In addition, there are new diet drug concerns related to an attempt to recreate fen-pen by the use of Prozac in place of Redux and/or Pondimin, and the new diet drug Meridia works in a very similar way to Redux and Pondimin. The lessons learned from fen-phen will be invaluable in other mass-tort pharmaceutical drug liability situations, and also with other diet drugs that are currently or soon to be on the market.

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Food and Drug Law, FDA, Fen-Phen, American Home Products, valvular heart disease

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Fen-Phen Litigation Against American Home Products… : DASH Story 2016-07-12
I am pursuing a Masters Degree in Clinical Translation Management at the University of St. Thomas in Houston, Texas. In the last spring semester I took a genetics class and the final project was to present a trial in an FDA regulatory case against American Home Products and their drug Fen-Phen. I partnered with a classmate to represent American Home Products in order to defend the company against the FDA's intentions to remove Fen-Phen from the market. I found this article on the web and it was my main source of reference to prepare the case against the classmates who represented the FDA. During my oral arguments in the case trial, most of the information that I gathered and then presented as evidence to defend American Home Products, was taken out of this Harvard Law student article. Two other classmates represented the jury in the trial. What was their verdict? They denied the FDA's request to remove Fen-Phen out of the market and the Genetics professors gave my classmate and I an A for the genetics final project.