While details about the settlement remain sketchy, it's clear that fen-phen continues to haunt its users years after it vanished as a legal weight loss supplement."Fen-phen refers to the use in combination of fenfluramine and phentermine ... fenfluramine ("fen") and phentermine ("phen") are prescription medications that have been approved by the FDA for many years as appetite suppressants for the short-term management of obesity," reads an FDA "Questions and Answers" sheet on fen-phen, issued September 1997.
The FDA approved phentermine in 1959, while fenfluramine got the nod in 1973. The two medications remained obscure until the 1990s, when a hybrid "cocktail" of the two substances became widely popular as a weight loss aid.
Problem was, the FDA never approved "fen-phen". While the U.S. government was fine with the use of the individual drugs that made up the cocktail, studies on the combined use of fenfluramine and phentermine were scanty.
This was unfortunate, because it was soon discovered that fen-phen caused some unpleasant side effects, including Primary Pulmonary Hypertension (PPH), a potentially fatal lung disorder.
"Primary or unexplained pulmonary hypertension (PPH) is a rare lung disorder in which the blood pressure in the pulmonary artery rises far above normal levels for no apparent reason," explains literature from The American Heart Association.
In 1996, The New England Journal of Medicine published an article regarding fen-phen. According to The Journal, taking the drug cocktail for a period of three months or longer increased your risk of developing PPH by roughly 23%.
The risk factor wasn't just theoretical either.
"On July 8, 1997, the Mayo Clinic reported 24 patients developed heart valve disease after taking fen-phen," states the FDA Q and A sheet.
Reaction in the medical community was swift. In September 1997, the FDA asked the makers of fenfluramine to voluntarily withdraw their product from the market. Fen-phen soon disappeared as a legal diet aid. During its legal lifetime, an estimated six million people took the drug combination.
Soon, anti-fen-phen lawsuits were flying. One of the main targets of this litigation was
Wyeth pharmaceuticals, (formally American Home Products, prior to a name change in 2002), which produced fenfluramine under the name, Pondimin.
Headquartered in Madison, NJ, Wyeth boasts 50,000 employees and 2006 revenues of $20.4 billion.
One lawsuit in particular, launched by the family Cynthia Cappel-Coffey, who died at age 41 in early 2003 from PPH, allegedly brought about by fen-phen use, attracted massive attention. This was because the suit was decided in favour of the aggrieved family, to the tune of $1 billion. Wyeth appealed this ruling, which was handed down in a Beaumont, Texas courtroom in 2004.
In early April 2007, lawyers for Cappel-Coffey and Wyeth came to a settlement in Beaumont, details of which have not been widely revealed.
This isn't the end of Wyeth's legal troubles, however. Two years ago, American Lawyer magazine estimated that former fen-phen users had launched 50,000 product liability lawsuits against Wyeth and other companies.
Given that the symptoms of PPH sometimes take years to manifest, it's likely there will be plenty more lawsuits to come, from people victimized by a once popular dietary aid.