Fen Phen
Settlement

Primary Pulmonary Hypertension (PPH) Common Symptoms
-Shortness of breath
-Chest pain
-Weakness
-New Heart Murmur
-Fatigue
-Fainting
-Tiredness
-Death

The New England Journal of Medicine 1996 study found:
Primary Pulmonary Hypertension (PPH) occurs in 1 in 500,000 people normally but occurs in 1 in 20,000 fen phen users. It is estimated that between 6 million and 7 million people in the U.S. have taken fen phen.

Controversy
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American Home Products (AHP), fen phen manufacturer, knew about the testing in Europe that found the diet drugs to cause primary pulmonary hypertension (PPH). Despite this knowledge, AHP did not list PPH under the 'adverse reaction' area of the drug's label. The labels on the fen phen bottles were not changed until the number of fatalities reached 62 due to PPH. The FDA later found AHP had miscoded PPH reports, in addition to failing to have an official medical monitor in 1995.

Allegations of Fen Phen Cover-Up
American Home Products (AHP) has been accused of covering up problems with fen phen that emerged during FDA testing according to a former FDA scientist. Dr. Leo Lutwak told CBS News in April 2000 that the company knew about problems long before the 1997 fen phen withdrawal. Lutwak claims that AHP contorted his research to make it appear that they had no way of predicting the dangerous health complications fen phen causes. Because the FDA would not let Lutwak testify, the former FDA scientist told CBS he was planning on retiring in order to make him available to testify.

Fen Phen Settlement

American Home Products (AHP) withdrew popular diet drug fen phen from the market on September 15, 1997. The once deemed “miracle drug” took off with an immediate 18,000,000 prescriptions written in 1996 and in the U.S. there are estimates that between 6 million and 7 million people took fen phen.

Fen phen did not live up to its name, though, as reports of a serious and fatal condition called primary pulmonary hypertension (PPH) began to surface. But evidence of the serious and fatal health complications fen phen could cause were available well prior to the FDA withdrawal. In a 1996 study published in The New England Journal of Medicine, it concluded that there is a twenty-three-fold increase in the risk of developing PPH when using fen phen for more than three months.

Up until the 1997 fen phen withdrawal, individual lawsuits and class actions in federal and state courts were filed against AHP due to the adverse health effects the drugs caused, including PPH. The fen phen lawsuits sought compensation to cover monetary damages, medical monitoring, and screening. December 10, 1997, the Judicial Panel on Multidistrict Litigation transferred all federal fen phen cases to the U.S. District Court, and negations of a nationwide settlement to settle the claims resulting from fen phen use began. The settlement class received preliminary approval on November 23, 1999, and on May 2, 2000 the court held a hearing to determine if the proposed Settlement Agreement was fair, adequate, and reasonable.

The Settlement Agreement was approved on August 28, 2000, and the AHP Settlement Trust was established as of September 1, 2000. The Trial Court Approval of the Settlement Agreement was appealed to a higher court and the ruling was affirmed on August 15, 2001. Although the appeal requested all the judges to rehear the appeal, the request was denied on October 3, 2001. Final Judicial Approval was received on January 3, 2002 for the Nationwide Class Action Settlement Agreement with American Home Products.

The claim deadline for the Fen Phen Settlement must be filed by August 2002.

For legal advice and/or more information regarding this matter, please contact us.


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Quotes
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"I couldn't walk more than a couple of feet without having to stop and catch my breath. I asked him (Dr. Lewis Rubin of the U of Maryland) what the prognosis was and he said that without medication, my life expectancy was about two years."
-Andrea Adams, former fen phen user who now suffers the fatal disease PPH. Adams began to notice PPH symptoms just 18 months after beginning fen phen
(CNN, 12-96)

"We had been concerned about PPH links to these drugs for years, but that was lost amid all the scuffle about the heart valve disease. That came out of the blue. No one was expecting it. There are two issues here because there's a big difference between the heart valve problems and pulmonary hypertension. The heart valve problem is bad, but at least it's something there's a cure for. You can replace the valve if you get it in time and so forth, but there's no cure for pulmonary hypertension."
-Dr. Sean Gaine, director of the pulmonary hypertension center at John Hopkins Medical Center in Boston.

"I felt from the very beginning the drug companies (American Home Products) were covering up. I felt from the very beginning that these drugs (fen phen) were dangerous.
-Dr. Leo Lutwak, former FDA key reviewer of fen phen
(CBS 4-00)