Fen-Phen Diet Drug Litigation (1990s): Understanding Settlements for Pharmaceutical Injuries
In the 1990s, the diet drug combination known as Fen-Phen promised a revolutionary solution for weight loss. However, this “miracle” drug soon turned into a nightmare for many, leading to severe health complications and one of the largest pharmaceutical injury litigations in history. This blog post delves into the Fen-Phen diet drug litigation, exploring the settlements awarded for pharmaceutical injuries and offering insights for those affected by similar situations.
The Rise and Fall of Fen-Phen
Fen-Phen was a combination of two drugs: fenfluramine and phentermine. Fenfluramine, marketed as Pondimin, and dexfenfluramine, sold as Redux, were appetite suppressants. While phentermine had been approved earlier, the combination of these drugs had never received specific FDA approval. Despite this, Fen-Phen became incredibly popular in the early to mid-1990s, with millions of prescriptions written.
However, the success was short-lived. In July 1997, the Mayo Clinic released a study highlighting a link between Fen-Phen and heart valve disease. This revelation led the FDA to request the withdrawal of fenfluramine and dexfenfluramine from the market in September 1997. The consequences were far-reaching, triggering a wave of lawsuits against the manufacturers, primarily American Home Products (AHP), which later became Wyeth, now a subsidiary of Pfizer.
The Fen-Phen Diet Drug Litigation: A Timeline
- 1973: Fenfluramine (Pondimin) is approved by the FDA for short-term use in dieting.
- 1992: The “Fen-Phen” combination gains popularity.
- Mid-1990s: Millions of prescriptions are written for Fen-Phen.
- July 8, 1997: The Mayo Clinic releases a study linking Fen-Phen to heart valve disease.
- September 15, 1997: Fenfluramine (Pondimin) and dexfenfluramine (Redux) are withdrawn from the market.
- October 7, 1997: Class-action lawsuits are filed against the manufacturers and distributors of Fen-Phen.
- 1999: American Home Products Corporation agrees to a significant settlement.
- August 2000: A $4.75 billion settlement is approved, offering medical monitoring and compensation.
Understanding the Settlements for Pharmaceutical Injuries
The Fen-Phen litigation resulted in one of the largest pharmaceutical settlements in history. In August 2000, a court approved a settlement valued at $4.75 billion to cover medical monitoring and compensation for those injured by the drug. This settlement eventually grew to an estimated $7.65 billion due to the increasing number of plaintiffs.
The settlement aimed to provide:
- Medical Monitoring: To detect and manage potential health issues related to Fen-Phen use.
- Compensation: For individuals who developed heart valve disease, pulmonary hypertension, or other related conditions.
Lieff Cabraser served as counsel for the plaintiff that filed the first nationwide class action lawsuit against the diet drug manufacturers alleging that they had failed to adequately warn physicians and consumers of risks associated with the drugs. Lieff Cabraser represented over 2,000 individuals who suffered valvular heart disease, pulmonary hypertension, or other problems and obtained more than $350 million in total for clients in individual cases and/or claims.
Levin Sedran & Berman served as Co-Lead Counsel in the Fen-Phen (Diet Drugs) litigation.
Common Injuries and Health Issues
The Fen-Phen litigation primarily addressed injuries related to the cardiovascular and pulmonary systems. The most common health issues included:
- Heart Valve Disease: Damage to the heart valves, particularly the mitral and aortic valves, leading to regurgitation (blood leaking backward).
- Pulmonary Hypertension: A condition characterized by high blood pressure in the arteries of the lungs, leading to shortness of breath, fatigue, and chest pain.
- Endocardial Fibrosis: A thickening and scarring of the inner lining of the heart.
Legal and Regulatory Ramifications
The Fen-Phen case had significant legal and regulatory ramifications. It underscored the importance of rigorous testing and regulation of drugs before they are marketed to the public. The case also highlighted the potential liability of pharmaceutical companies for failing to adequately warn consumers about the risks associated with their products.
Are Fen-Phen Claims Still Being Filed?
While the initial settlement has long passed, some individuals may still be eligible to file supplemental claims if their condition has worsened. To qualify, individuals generally needed to have:
- Registered with the AHP Settlement Trust on or before May 3, 2003.
- Provided proof of use of Pondimin or Redux.
- Established a baseline heart valve injury with a qualifying echocardiogram.
- Previously received Matrix Compensation from the Original AHP Settlement Trust.
Advice for Those Affected by Pharmaceutical Injuries
If you believe you have been injured by a pharmaceutical drug, consider the following steps:
- Seek Medical Attention: Consult with a healthcare professional to assess your condition and receive appropriate treatment.
- Gather Medical Records: Collect all relevant medical records, including prescriptions, test results, and doctor’s notes.
- Consult with a Personal Injury Attorney: An experienced attorney can evaluate your case, explain your legal options, and help you pursue compensation for your injuries.
- Be Aware of Deadlines: States have statutes of limitations that set deadlines for filing lawsuits. It is essential to consult with an attorney as soon as possible to ensure that you do not miss any deadlines.
Other Notable Pharmaceutical Settlements
The Fen-Phen litigation is just one example of the many cases where pharmaceutical companies have faced legal action for injuries caused by their products. Other notable cases include:
- Opioid Crisis: Settlements with pharmaceutical companies like Cardinal Health, McKesson, AmerisourceBergen, and Johnson & Johnson for their role in the opioid crisis, reaching billions of dollars.
- GlaxoSmithKline (2012): A $3 billion settlement for unlawfully promoting prescription drugs and failing to report safety information.
- Pfizer (2009): A $2.3 billion settlement for the false promotion of drugs like Bextra, Geodon, Lyrica, and Zyvox.
- Johnson & Johnson (2013): A $2.2 billion settlement for misbranding the antipsychotic drug Risperdal.
- Abbott (2012): A $1.5 billion settlement for the unlawful promotion of Depakote for unapproved uses.
Conclusion
The Fen-Phen diet drug litigation serves as a stark reminder of the potential risks associated with pharmaceutical drugs and the importance of holding manufacturers accountable for their actions. While the case is now decades old, its impact continues to be felt by those who suffered injuries and by the legal and regulatory landscape that has evolved in its wake. If you or someone you know has been affected by a pharmaceutical injury, seeking legal advice and understanding your rights is crucial.