Fen Phen

In 1997 the FDA asked American Home Products a the makers of Pondimin (Fenfluramine) and Redux (Dexfenfluramine), to withdraw it's popular anti-obessity drugs from the market.American Home Products Corp. of Madison, N.J., manufactured fenfluramine under the brand name Pondimin and a American Home Product's subsidiary Wyeth-Ayerst Laboratories, manufactured Dexfenfluramine for Interneuron Pharmaceuticals, which was marketed under the name of Redux. Medical studies have linked Pondimin or Redux to heart valve.

The FDA stated that in findings from doctors who evaluated patients that took Fenfluramine and Dexfenfluramine, with echocardiograms, that approximately 30 percent of patients who were evaluated had abnormal echocardiograms, even though they had no symptoms. This is a much higher than expected percentage of abnormal test results.

Additionally a Mayo Clinic study that was published in the New England Journal of Medicine on August 28, 1997 suggested that as high as one-third of a patient sampling of Fen-Phen diet pill users had evidence of heart valve disease. The study found that there was a high incidence of heart valve disease in patients taking these diet pills, without any other known reason for valve disease.

In addition to heart valve disease the use of fenfluramine and dexfenfluramine has been found to increase the risk of developing Primary Pulmonary Hypertension or (PPH). PPH is a rare disease of that causes the progressive narrowing of the blood vessels of the lungs. Studies estimate that treatment with certain appetite suppressant drugs tends to increase the chances of developing PPH by approximately 25 to 30 percent.

Medical reports have also linked Pondimin (fenfluramine hydrochloride) to the occurrence of serious regurgitant cardiac valvular disease, including disease of the mitral, aortic, and/or tricuspid valves. In one medical study, 24 patients, who received combination therapy with fenfluramine and phentermine for treatment of obesity, were found to have regurgitant cardiac valvular disease; five of these patients required valvular surgery. There have also been reports that taking fenfluramine alone can cause valvular disease.

In 1999, American Home Products agreed to pay as much as $3.75 billion to settle lawsuits over its Redux and Pondimin diet drugs, in what would be a record injury settlement involving a pharmaceuticals company. The agreement would provide benefits, ranging from drug refunds to injury payments of as much as $1.4 million a person, for the six million or so people who took the drugs. However, many victims and lawyers don't feel the settlement was far reaching enough, as it left out thousands of injuries.

The amounts which individuals are entitled to recover under this Settlement depend on the person's age at diagnosis of valvular heart disease, the person's "Level of Severity" and additional criteria as set forth below.

Matrix A-1 For Diet Drug Recipients:

Matrix Level I is severe left sided valvular heart disease without complicating factors, and is defined as one of the following:

(a)Severe aortic regurgitation (AR) > 5O% jet height/left ventricular outflow tract height (JH/LVOTH)3 and/or severe mitral regurgitation (MR) > 40% regurgitant jet area/left atrial area (RJA/LAA)4,5; and no complicating factors as defined below;
(b) FDA Positive valvular regurgitation 6 with bacterial endocarditis contracted after commencement Pondimin and/or Redux use.

Matrix B-1 For Derivative Claimants:

For claims as to the mitral valve, Diet Drug Recipients who were diagnosed as having Mild Mitral Regurgitation (regardless of the duration of ingestion of Pondiminand/or Redux).

Diet Drug Recipients who ingested Pondimin and/or Redux for 60 days or less, who were diagnosed as FDA Positive.
Diet Drug Recipients who ingested Pondimin and/or Redux for 61 or more days, who were diagnosed as FDA Positive with any of the following conditions:

With respect to an aortic valve claim:

The following congenital aortic valve abnormalities: unicuspid, bicuspid or quadricuspid valves, ventricular septal defect associated with aortic regurgitation.

Aortic dissection involving the aortic root and/or aortic valve;
Aortic sclerosis in people who are > 60 years old as of the time they are first diagnosed as FDA Positive
Aortic root dilatation >5.0 cm
Aortic stenosis with an aortic valve area <1.0 square centimeter by the Continuity Equation.

For the Diet Drug Recipients' spouses, children and "significant others":

Diet Drug Recipients' spouses, children and "significant others" ("Derivative Claimants") may also be eligible for Matrix Payments under the law and if so, they will be paid an amount set forth in one of the "Derivative Matrices".

Matrix A-2 is used where the Diet Drug Recipient was eligible for Matrix A-1 payments.

Matrix B-2 For Derivative Claimants is used where the Diet Drug Recipient was eligible for Matrix B-1 payments.