As any person who has fought with his or her weight is aware, losing weight is not easy. Yet carrying extra pounds can have a significant impact on health and self-esteem. As a consequence, there is an enormous market for dietary supplements and drugs which can help people lose weight.
In the late 1990's, the drugs known as Fen Phen, Redux, and Pondimin were frequently prescribed to assist with weight loss. In 1996, approximately 18 million prescriptions were written by U.S. doctors for Fen Phen. "Fen Phen" refers to the simultaneous prescription of fenfluramine (Fen...) and phentermine (Phen...).
As many as twenty percent of people who took those drugs suffered heart damage, including:
Damaged Heart Valves: The drugs Fen Phen and Redux are associated with damage to the heart's aortic and mitral valves; and
Primary Pulmonary Hypertension (PPH): A condition is caused by a narrowing of the blood vessels in the lungs, which can cause high blood pressure and can lead to heart failure. This condition is extremely serious, is usually progressive in nature, and can result in death. It has been associated with Fen Phen and Pondimin.
Ultimately, the makers of Pondimin and Redux voluntarily removed those products from the market at the request of the FDA, as a result of growing safety concerns.
The dangers of those drugs arose from their being simultaneously prescribed with phentermine. While Pondimin and Redux had been approved for short-term treatment of obesity, the FDA did not approve the combination of those drugs with phentermine - nor was any such approval required by law.
Manufacturer liability was based upon the assertion that it was known for many years that the use of Pondimin and Redux could lead to primary pulmonary hypertension (PPH), but the manufacturers downplayed the health consequences in order to maintain a very lucrative market for their drugs.