Fen-Phen

In 1997, the FDA asked American Home Products Corporation (now doing business as Wyeth, Inc.), the makers of Pondimin® (fenfluramine) and Redux™ (dexfenfluramine), to withdraw it's popular diet drugs from the market. American Home Products Corporation of Madison, New Jersey, manufactured fenfluramine under the brand name Pondimin® and the 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® and Redux™ to heart valve and lung problems.

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 drug 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.

Heart Valve Damage
The two most common heart valve disorders are aortic valve regurgitation and mitral valve regurgitation. Aortic valve regurgitation and mitral valve regurgitation occur when the aortic and mitral valves are damaged or not working properly.

Heart valves help blood flow in only one direction as it moves between different chambers of the heart and into and out of the heart. Aortic valve regurgitation occurs when the flaps of the aortic heart valve do not form a tight seal, which allows blood to leak backwards through the valve when the heart muscle relaxes. Aortic valve regurgitation may reduce blood flow to organs throughout the body, including the heart muscle itself. As a result of the reduced blood flow, the heart may need to pump harder, which over years, may enlarge the lower left heart chamber.

During the early stages of aortic valve regurgitation, a person may not experience any symptoms, but the reduced blood flow eventually can cause chest pain, palpitations or irregular heartbeats (arrhythmias), a serious infection in the heart (endocarditis), heart failure, and in rare cases, sudden death. Sometimes a person may only notice symptoms once heart failure develops. There are certain instances when aortic valve regurgitation can occur suddenly, and will include severe symptoms such as shortness of breath and extreme tiredness. In this case, a person should seek immediate medical attention. Medications to lower blood pressure are usually used to treat aortic valve regurgitation. If the valve leakage is severe and the heart is unable to keep up with the increase in pumping, surgery may be needed to replace the aortic valve.

Like aortic valve regurgitation, mitral valve regurgitation usually develops over many years. In the case of mitral valve regurgitation, a significant amount of blood flows back into the left atrium through the leaky mitral valve. In an attempt to circulate this extra blood, the left ventricle pumps harder and may enlarge over time. After many years of increase pumping, the left ventricle may become weaker and symptoms of heart failure can develop.

Mitral valve regurgitation is a common disorder, but the disorder can range from mild to severe cases. Some people will never develop symptoms and the condition may not get worse, but mitral valve regurgitation can also develop suddenly. A person may experience symptoms such as severe shortness of breath (dyspnea), fluid in the lungs and chest pain. People who develop sudden mitral valve regurgitation almost always need urgent surgery to repair or replace their mitral valve.

A number of causes can lead to both aortic valve regurgitation and mitral regurgitation. Some causes include conditions such as aortic valve stenosis and endocarditis; infections such as rheumatic fever and injury, such as trauma to the heart valve or aorta; inherited and autoimmune diseases; and heart abnormalities present from birth. The use of diet drugs such as fenfluramine and dexfenfluramine, also appear to significantly increase the risk of heart valve disease.

Depending on the damage, heart valves may either be repaired or replaced. Sometimes the surgeon can restore the valve to function normally by remodeling the tissue (removing stretched tissue or sewing the edges). Heart valves that are seriously deformed or degenerated cannot be repaired. The old valve is removed and replaced with a new valve mechanism. A new valve is attached by sewing it to a rim of tissue kept from the original valve. The replacement heart valves are either natural (biologic) or artificial (mechanical). Natural valves are from human donors (cadavers), modified natural valves are from animal donors (porcine: pigs), which are placed in synthetic rings, and artificial valves are made of metal or plastic. Natural valves typically require the use of anti-rejection medications, whereas artificial valves will typically require life-long anticoagulation medication to prevent blood clot formation.

Primary Pulmonary Hypertension
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 that causes the progressive narrowing of the blood vessels of the lungs, which causes higher blood pressure in these blood vessels and eventually leads to heart and/or lung failure. Various studies indicate that these diet drugs may increase the chances of developing PPH by approximately 25 to 30 percent, especially in those people who have used the drugs for more than three months.

The first symptoms of PPH may be very minor, which sometimes delays the diagnosis. A person with PPH may experience shortness of breath following exertion, excessive fatigue, dizziness, fainting, ankle swelling, bluish lips and skin and chest pain. Even if the disease has progressed, the signs and symptoms may be hard to detect or even confused with other conditions that affect the heart and the lungs. A physician may determine if a patient has PPH through a cardiac catheterization.

PPH is treated with a number of drugs, which can't cure or halt the progression of this disease, but they may relieve symptoms. Some patients take vasodilators, which help to dilate the blood vessels in the lungs, which reduces the blood pressure in them. In addition, anticoagulants may be used to decrease the tendency of the blood to clot in the lungs. Although some patients do well with medication, others with severe PPH may need a lung transplantation or heart and lung transplantation.

It is hard to detect the number of PPH cases, however, it is estimated that there are 300 new cases per year. PPH is more common in women between the ages of 21 and 40, but it can affect anyone at any age.

Litigation
American Home Products (Wyeth, Inc.) estimates that about 6 million people took these diet drugs before they were pulled off the market by the FDA in 1997. On January 3, 2002, a nationwide class action settlement for thousands of people who took the Fen-Phen diet drug combination received Final Judicial Approval and became final. Final Judicial Approval meant that certain new procedures took place under the Settlement Agreement.

The filing deadline for all class action Matrix and Opt-Out claims was May 3, 2003. Since that time, the Trust has obtained Judicial approval to institute additional claims processing procedures, including the audit of each and every claim by the Trust’s cardiologists, to determine whether the claim will be paid or denied. This has delayed payment of virtually every claim filed and created a large backlog of unpaid claims.

Time Limits on Filing Suit
Every case has a statute of limitations that will apply. It varies by the type of case and the state where the case is filed. Don't wait until there is trouble or until the end of your case to get a lawyer. Your attorney would prefer to be involved every step of the way, to monitor your case, to guide you, to prevent trouble, and to assist you.

Irwin & Boesen represents persons who have been injured by dangerous drugs. Please contact us for an honest and fair evaluation of your case.