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Notorious diet drug Fen Phen had been removed from the market in the late 1990s, after the FDA requested a voluntary recall. Although manufacturers settled initial claims in the early 2000s, a lingering issue concerning Fen Phen’s usage surfaced nearly 15 years larger: associated primary pulmonary hypertension (PPH), a condition with no cure resulting in lung and heart damage and heart failure.
Older and Newer Cases
Fen Phen is composed of two drugs: fenfluramine (also known as Pondimin) and phentermine (Ionamin). Both drugs had been approved in the 1950s for medically-monitored weight loss, but their combination – used in Fen Phen and Redux (dexfenfluramine) – had never been approved in the U.S. Manufacturers, however, pressured doctors to recommend the combination for off-label use as an appetite suppressant.
By 1996, 6 to 7 million people had taken Fen Phen or Redux, with 18 million prescriptions filled. However, results from an obesity study at the time found that 30 percent of subjects experienced a heart valve defect.
In response to the study and the FDA’s motion, 50,000 lawsuits were filed against manufacturers, with a $3.75 billion settlement in 2002. At the time, however, claims only concerned mitral and aortic valve regurgitation and not PPH, and alleged Wyeth withheld information about Fen Phen’s serious risks.
But just two years later, claims associating Fen Phen use with delayed development of PPH began to appear in courts, with manufacturer Wyeth paying $1 billion to a former Fen Phen user who died from PPH.
By September 2012, Pfizer, who absorbed Wyeth, attempted to have PPH-related Fen Phen claims dismissed in a Philadelphia court but lost. This group of cases alleges Fen Phen is associated with development of PPH more than 10 years after usage, but Pfizer claims no evidence supports this correlation.
As of 2013, 106 cases were pending in multi-district litigation, and Wyeth had set aside an additional $21 billion to settle this smaller group of claims.
Filing a Lawsuit
For this recent group of Fen Phen cases, patients who weren’t part of the initial settlement but developed PPH and those who were involved more than 10 years ago can file a claim. Statute of Limitations, in this case, is not based on when manufacturers withdrew Fen Phen and Redux but instead when a patient developed PPH. However, all plaintiffs involved must provide supporting evidence showing PPH is not associated with another source.
