Kip Petroff No Comments

Wonder if it’s worth complaining? How seven complaints in Fargo, North Dakota resulted in the largest and most expensive drug recall in American History.

My last blog urged consumers to speak up about defective products. Consumers are the ones with the most information, but when faced with the task of actually filing a report, some are understandably hesitant. It’s the same kind of reluctance that keeps many well-minded citizens from voting: “Why bother? My opinion will never make a difference anyway!” But the truth is you can make a difference.

The Fen-Phen Recall of 1997

“Fen-Phen” was a combination of two FDA-approved weight loss drugs that were highly sought after in the 1990’s. The massive popularity of Fen-Phen was eclipsed only by that of Redux, a drug that was supposed to be the once-a-day, new and improved version. Redux was approved for weight loss in 1996 amid massive media attention. Together, they were poised to become blockbuster obesity solutions.

American Home Products stood to profit from the sale of both these drugs. And profit they did! Hundreds of thousands of new prescriptions for Fen-Phen and Redux were written in the year after Redux was approved, bringing the total estimated users nationwide to six million. People across the US were shedding pounds effortlessly! It looked like the world would become a thinner, healthier place thanks to a new “magic pill.”

But there was a problem.

In early 1997 in North Dakota, a cardiac sonographer noticed a pattern. Several young women who had taken Fen-Phen were now having rare left-sided heart valve leakage. She mentioned this to the cardiologists in her group, and they contacted the Mayo Clinic who then contacted American Home Products and the Food and Drug Administration. By July of 1997, it became evident that the popular weight loss drug came at a dangerously steep price.

A press conference was held at the Mayo Clinic that summer, and American Home Products, under pressure from the FDA, “voluntarily” recalled the drugs and initiated a massive public safety and product recall.

It was originally estimated that as many as 2 million people might have been sickened – a true public health crisis. Tens of thousands of Fen-Phen users returned their unused prescriptions and rushed to their doctors for urgent care. Thousands of medical tests were run in the first month alone, while thousands more enrolled in medical studies. An astronomical number of lawsuits were filed, making Fen-Phen the largest pharmaceutical recall and mass tort litigation in the history of the United States.

Why should you report a faulty or defective product? The Fen-Phen recall was the direct result of one woman, a technician, following through on a suspicion many others might have ignored. Her actions almost certainly prevented hundreds, if not thousands, of additional heart problems and set in motion events that would compensate those already injured.

My partner and I tried the first Fen-Phen lawsuit, and we were able to prove that American Home Products, known by then as Wyeth, had been aware of health risks but had failed to inform the public. My firm would go on to try several additional Fen-Phen cases and would settle over 10,000 – a small fraction of those that existed nationwide. It was a major medical mistake that resulted in thousands of damaged hearts, hundreds of products liability trials, and more than $22 billion dollars in damages – a price today’s pharmaceutical consumers continue to pay.

The Fen-Phen Lesson

Fen-Phen litigation was my full-time job from 1997 to around 2005. My firm tried four individual cases to jury verdict, relying heavily on those initial Fargo sonogram reports. To this day, the experience stands as a shining example of how a tiny bit of data, when viewed with a watchful eye, can impact millions. Your formal complaint becomes one dot on a blank sheet of paper. Maybe it will be the only one, but maybe it will join others, and a pattern will begin to emerge, allowing a governmental field investigator to connect the dots and see a red flag before more people get hurt.

The “Consumer Corner” on my firm’s website makes reporting easy by providing a separate button for each of the most common consumer complaints. Each agency has a toll free number, and you can also contact my firm directly through the online Contact Form, if you still have questions. Gather your documentation, press the appropriate button in the Consumer Corner, and the complaint process will be over before you know it. You’ll be glad you did!