The Higgins Firm is a full service law firm that has extensive experience representing the interests of those injured by countless harmful drugs and medical devices, including the weight loss drugs commonly known as Fen-Phen. While the dangerous side effects of Fen-Phen have been known for several years now, the damaging effects are still being felt by those who were prescribed the drugs years ago. The Higgins Firm has successfully represented a number of those harmed by the drugs, and we are ready to help the many others who have suffered as a result of taking Fen-Phen.What is Fen-Phen?
Fen-Phen is a combination of two different diet drugs—Fenfluramine and Phentermine—that first came on the market in 1992. Phentermine was approved by the United States Food and Drug Administration (“FDA”) in 1959 as a weight loss drug to be used over a short period. The drug, which acts like amphetamine and other stimulants, suppresses one’s appetite and tricks the body into feeling full after small meals. The second drug, Fenfluramine, was approved by the FDA in 1973 for use as a short-term weight loss aid. The drug works by depressing the central nervous system and raising serotonin levels in the bloodstream. This allows a person to feel full after eating only small amounts of food, much like Phentermine. It also causes grogginess and fatigue.
The combination of the two drugs began being prescribed after a study was published in 1992 touting the increased efficacy of the drugs when used in tandem. The study indicated that some of the side effects of the drugs (i.e. drowsiness, fatigue, dry mouth, insomnia, irritability, and in some case pulmonary hypertension) could be reduced when both drugs were taken at lower doses, for longer period of time. The problem, however, was that neither of the drugs were considered safe for use beyond one year, as noted by the FDA.Why is Fen-Phen Dangerous?
While the two drugs were each approved by the FDA for individual use, the combination of the two drugs was never approved. Nevertheless, doctors began prescribing the combination to their patients. Fen-Phen was prescribed rampantly, and nearly six million Americans were prescribed the drug combination while it was available. However, just five years after the Fen-Phen combination first hit the market, another study was published that detailed the long-term negative side effects of the drugs. The Mayo Clinic released the results of a research study in 1997, reporting the onset of cardiac valvular disease and pulmonary hypertension in twenty-four (24) women who had taken the two drugs—this was a third of the participants studied.
Cardiac valvular disease, or heart valve disease, occurs when one of the four heart valves (mitral, aortic, tricuspid or pulmonary) has been damaged. When functioning properly, heart valves control the force and direction of blood flow. In a patient with cardiac valvular disease, the heart valves are too narrow or hard to fully open and close in order to control blood flow. This can lead to complications such as stroke, pulmonary embolism, enlarged heart muscles or congestive heart failure. While certain antibiotics and antithrombotic medications can help treat the systems, valve surgery is often necessary to repair the damage.
Primary pulmonary hypertension/pulmonary arterial hypertension (PPH/PAH) is another common side effect of taking Fen-Phen. PPH/PAH is a condition that develops when scar tissue forms on the inner lining of the pulmonary artery. Scar tissue constricts the blood flow through the artery and, in turn, reduces the amount of blood that can be oxygenated. PPH/PAH manifests as shortness of breath, and can include such systems as swollen extremities, fatigue, weakness, fainting, continuous high blood pressure, and, in some cases, enlarged liver. There is no cure for pulmonary hypertension.
Due to the seriousness of the side effects, the FDA recalled Fen-Phen and ordered it off the market only months after the study was released.The Ensuing Litigation
Not long after the Mayo Clinic study was published, hundreds of lawsuits began to be filed. Trial lawyers began collecting cases to form class action lawsuits to be filed against the distributer of the drugs, American Home Products/Wyeth. As of 2005, over 50,000 had been filed by those injured by the drugs. Some estimate that, to date, more that $14 billion has been paid to injured victims.The Lasting Effects
Although Fen-Phen was taken off the market nearly twenty years ago, some who took the drugs in the nineties are only now experiencing the side effects. In some cases, those who took the drug combination are being diagnosed with lung and heart diseases over a decade after the last use. While the drug manufacturer argues that such cases should be thrown out, the judge overseeing all federal Fen-Phen cases across the country has ruled that these cases can go forward.What You Should Do
If you have been diagnosed with pulmonary hypertension or heart valve disease as a result of taking Fen-Phen, we encourage you to contact The Higgins Firm today. You may be entitled to substantial compensation. Our Nashville Fen-Phen attorneys are ready to discuss your potential claim and help you determine the next step.