FDA and Europe at Odds Over Meridia Ban, a Perfect Storm for Lawsuits
The bell appears to be tolling for Meridia (sibutramine), Abbott Labs (ABT)'s diet drug. The European Medicines Agency banned the drug on Thursday, saying the increased risk of heart attacks outweigh its benefits.
That puts Europe and the U.S. on a collision course over the drug: On Wednesday, the FDA restricted its use in the U.S. to patients who do not have heart problems but kept the drug on the market. At the same time, there have been calls to ban the drug in the U.S. since 2002.
Plaintiffs' lawyers will be sharpening their knives over the news: There's a dangerous drug on the market in America, generating heart problems -- and new clients. The question now becomes, What did Abbott know about cardiovascular events with Meridia, and when did the company know it?
The Europeans banned the drug because the FDA found that an extra 1 percent or more of users develop heart problems after taking it. There were 86,000 European users in the past year, the BBC reported, which means that 860 have damaged hearts because of Meridia. Officials said the drug doesn't work very well anyway:
Dr June Raine, of the [Medicines and Healthcare Products Regulatory Agency], said: "Evidence suggests that there is an increased risk of non-fatal heart attacks and strokes with this medicine that outweigh the benefits of weight loss, which is modest and may not be sustained in the long term after stopping treatment.We can even calculate the number of potential plaintiffs against Abbott: Public Citizen said there were 249,000 users in the U.S. In the FDA's study, an extra 70 patients of 5,000 taking Meridia developed heart problems compared to the placebo group. That means about 3,486 American patients developed heart problems from Meridia in just the last year.